Therefore, it is important that immobilization of the site is maintained until firm bony union (confirmed by clinical and radiological examination) is established. 3. Background The physician must determine if the device is appropriate for patients having any of the following physical or emotional conditions: It is the responsibility of the surgeon to provide the patient with appropriate information prior to surgery.Prior to surgery, the surgeon should discuss with the patient all possible risks versus potential benefits of treatment considering the patients preoperative condition and expectations for improvement in his/ her condition postoperatively. No reassembly is necessary as the instruments remain in their fully disassembled form during cleaning and sterilization. :http://www.medshape.com/patents.htmlMK-10161 Rev. We also use cookies to target our marketing to your needs. Neither DJO, LLC nor any of the Enovis companies dispense medical advice. The initial clinical outcomes with the DynaNail Mini Fusion System for subtalar fusion procedures were reported today by MedShape. These guidelines are not intended for MedShape implants or single-use disposable instruments only for reusableinstruments that are supplied non-sterile but are intended to be used in a sterile state. Persons with allergic reactions to these metals may suffer an allergic reaction to this implant. Single: A standard packaging material may be used. Ensure that the pack is large enough to contain the instrument without stressing the seals. Loss of fixation in bone attribute to nonunion, osteoporosis and/or markedly unstable comminuted fractures. If any of the components are damaged during attempted placement, additional sterile components of the same size should be available. It has not been tested for heating, migration, or image artifact in the MR environment. Patients with conditions that restrict his or her ability or willingness to follow postoperative instructions during the healing process. Printed in USA.Pat. An item which poses unacceptable risks to the patient, medical staff or other persons within the MR environment. Unlike traditional screws that lose compression post-operatively, the DynaNail Hybrid maintains compression up to 5 mm of bone settling or resorption depending on implant length.1, The DynaNail Mini Fusion System is an innovative intramedullary nail system designed for use in subtalar fusion procedures, medial column fusion procedu. To view the purposes they believe they have legitimate interest for, or to object to this data processing use the vendor list link below. In the case of very small dimension cannulations, a wire can be used to ensure that foreign material has been removed from the cannulation. Serious postoperative complications may occur from use of the implant in a patient who: This device contains NiTiNOL, an alloy of nickel and titanium. Moist heat/Steam is the only method that has been validated for reprocessing by MedShape. Prolonged exposure to saline may result in corrosion of stainless steel instruments. In the absence of a bursa or pain, removal of the implant in elderly or debilitated patients is not recommended. Demonstrated psychological instability, inappropriate motivation, or attitude. The DynaNail TTC Fusion System is designed for use in tibiotalocalcaneal (TTC) fusion, or hindfoot fusion, procedures to address degenerative conditions, correct joint deformities and revise failed total ankle replacements or arthrodesis non-unions. Prior to surgery, the surgeon should discuss with the patient all possible risks versus potential benefits of treatment considering the patients preoperative condition and expectations for improvement in his/her condition postoperatively. Patients with an active soft tissue infection or osteomyelitis of foot and ankle. All instruments should be thoroughly cleaned. 03. Store the DynaNail Deployment Frame and Ancillary Surgical Instruments in the DynaNail Instrument Caddy. After implanting DynaNail, the Compressive Element is stretched 6 mm and fixed in the stretched position with two screws (one posterior-anterior and one lateral-medial) in the calcaneus allowing. Patients with conditions that restrict his or her ability or willingness to follow postoperative instructions during the healing process. The surgeon is responsible for patient selection. Patients with an obliterated medullary canal or other conditions that tend to retard healing such as blood supply limitations or previous infections. DO NOT ATTEMPT TO RESTERILIZE. Demonstrated psychological instability, inappropriate motivation, or attitude. THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS, IMPLIED, AND/OR STATUTORY, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY, FITNESS, AND/OR SUITABILITY FOR A PARTICULAR PURPOSE, AND OF ALL OTHER OBLIGATIONS OR LIABILITIES ON MEDSHAPES PART. Internal NiTiNOL element offers between 2 - 5 mm of Never attempt to reuse. Release the Fusion Nail from the Deployment Frame by unscrewing the connection screw. Store the DynaNail TTC Fusion Nail, DynaNail End Cap, and DynaNail Screws in a dry place at room temperature (20C to 25C). Gravity displacement sterilization is not recommended due to extended cycle times. Moist heat/steam is the only method that has been validated for reprocessing by DJO. The Fusion Nail is manufactured from nitinol and titanium alloy (Ti6Al-4V ELI) and is available in multiple diameters and lengths. Containment devices can be stacked forstorage. Pain, discomfort, or abnormal sensations due to the presence of the implant. All cleaning should be performed in a manner designed to minimize exposure to bloodborne pathogens. Carefully inspect product packaging and all device components for damage or defects prior to use. It is the responsibility of the user to ensure that the sterilization process is actually performed using qualified equipment, materials, and personnel such that the recommended parameters are achieved. Designed for use in subtalar fusion procedures, the DynaNail Hybrid contains an Superelastic Internal NiTiNOL Element that maintains active, dynamic compression in response to bone settling or resorption. Misuse, mishandling, and/or improper operation.b. The patient should not have unrealistic expectations regarding the results that the surgery and implant may provide. Irritational injury of soft tissues, including impingement syndrome. Return Conditions:In the event the device must be returned for any reason, return the product in the original packaging. Contact Customer Service or an authorized MedShape representative to receive a return authorization number prior to return shipment. Contaminated instruments should be transported to the area for cleaning in a way that avoids contamination of personnel and hospital.1.Use flowing water and disposable wipes to remove excess soil.2.Presoak the instruments with an enzymatic solution for a minimum of five (5) minutes.3Following the presoak the instruments should be wiped or scrubbed using a brush, cloth or sponge that does not mar the surface of the instrument.4.Rinse parts under cold (<45C) sterile water for a minimum of one (1) minute.5Repeat the process until no visible debris remains.6.Soak the instruments in Ultra Clean System Low Foam Detergent (pH neutral) for a minimum of one (1) minute. For manual washing, MedShape recommends using cold demineralized or distilled water along with a neutral pH (7-8.5) enzymatic detergent. The DynaNail Mini Fusion System is used for fracture fixation . Any recommendations provided herein are provided as general guidelines only. Limited LiabilityThe DynaNail Helix Threaded Bone Fastener and DynaNail Helix Washer are guaranteed for materials, function, and workmanship for a single patient use.The Ancillary Surgical Instruments are guaranteed to be free from defects due to materials or workmanship and have a one (1) year limited warranty.DJO shall not be liable, expressly or implied for any damage which might arise or be caused, whether by the customer or by any of the users of the product, as a result of: THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS, IMPLIED, AND/OR STATUTORY, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY, FITNESS, AND/OR SUITABILITY FOR A PARTICULAR PURPOSE, AND OF ALL OTHER OBLIGATIONS OR LIABILITIES ON DJOS PART. The patient should be informed that the life expectancy of the device is unpredictable once implanted and that successful results cannot be guaranteed. Systemic or metabolic disorders or replacement. Dupont KM, Shibuya N, Bariteau JT. Rigid sterilization container that complies with ANSI/AAMI ST46. Extreme care must be taken when following the technique for removal of the device. 3. Damage to the implants surface finish may result in loss of proper mechanical function of the device. Visually inspect all instruments for damage and wear. Indicates the medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/EEC and. Global J Orthopedic Research, 2019. For manual washing, DJO recommends using cold demineralized or distilled water along with a neutral pH (7-8.5) enzymatic detergent. Loosening, bending, cracking, or fracture of the implant components. It has not been tested for heating or migration in the MR environment. 1 djo dynanail helix fixation system. In Sets: Load MedShape Surgical Instruments into the appropriateinstrument trays. The DynaNail Mini is provided with the NiTiNOL Element pre-stretched and pre-loaded on a disposable Nail Guide. According to ANSI/AAMI standards ST79:2017, the accepted standard for the degree of cleanliness is visibly clean. Call your DJO sales representative for a replacement. Call your MedShape sales representative for a replacement. Each surgeon must evaluate the appropriateness of the device and the procedure used to implant the device based on his/her own training and experience. Postoperative care and physical therapy should be structured to prevent loading of the operative extremity until stability is evident. Washer-decontaminators may also be used in addition to manual cleaning. Carefully inspect sterile packaging for damage prior to use. If the sterile packaging is found to be damaged or open, do not use the device or attempt to resterilize. Inspect all components preoperatively to ensure that the device components and instruments are appropriate for use. The healthcare facility is responsible for in-house procedures for the reassembly, inspection, and packaging of the instruments after they are thoroughly cleaned in a manner that will ensure steam sterilant penetration and adequate drying. The DynaNail Mini Fusion System is implanted using the DynaNail Mini Deployment Frame and Ancillary Surgical Instruments. Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure. Avoid contacting the implant with other tools or materials that could notch, scratch, or otherwise damage the implant surface. About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . The DynaNail Mini is provided with the NiTiNOL Element pre-stretched and pre-loaded on a disposable Nail Guide. The latest addition to DJO's robust suite of foot and ankle products and an expansion of the DynaNail Mini line, the system leverages MedShape's proven active, adaptive healing technology 1 . Inspect all components preoperatively to ensure that the device components and instruments are appropriate for use. Never attempt a surgical procedure with defective, damaged or otherwise compromised instruments or implants. Always follow the sterilizer manufacturer recommendations. Refer to the Instrument Tray and/or illustration in DJOs Surgical Technique Guide for the completely disassembled components. Has immunological responses, sensitization or hypersensitivity to foreign materials. Any patient who cannot properly utilize weight support devices may be particularly at risk during postoperative rehabilitation. The Ancillary Surgical Instruments must be placed in the designated location within the DynaNail Helix Instrument Tray. DJO Wrist and Finger Undersleeve Instruction Manual, MAYTAG 4.5 Cu. Rather, please consult your healthcare professional for information on the courses of treatment, if any, which may be appropriate for you. Has immunological responses, sensitization, or hypersensitivity to foreign materials. It is critical that the appropriate process parameters be validated for each healthcare facilitys sterilization equipment and product/load configuration by persons who have training and expertise in sterilization processes to substantiate the process and its reliability and reproducibility. Offers between 2-4 mm of post-operative active compression PLUS intra-operative manual compression Provides strong joint stability due to maintained compression TABLE A. Failure to do so may result in loosening, bending, cracking, or fracture of the device or injury to the patients bone or both. pH neutral detergent. Inspect all components preoperatively to ensure that the device components and instruments are appropriate for use. The use of this product is intended to be limited to persons trained in the procedure and knowledgeable of the inherent risks. The DynaNail Helix Threaded Bone Fastener is manufactured from nickel titanium alloy and titanium alloy (Ti6Al-4V ELI) and is available in multiple lengths. DynaNail Helix comes with the NiTiNOL Element prestretched and pre-loaded on a disposable Nail Guide that connects directly to the ratcheting handle for easy insertion. central supply wrap (CSR), paper/plastic pouches, rigid containers, etc.) Patients with severe longitudinal deformity. If sensitivity to nickel or titanium is suspected, appropriate testing should be conducted prior to use. The DynaNail Mini Fusion System features MedShape's patented superelastic nickel . Contact Customer Service or an authorized DJO representative to receive a return authorization number prior to return shipment. The surgeon must make the final decision regarding implant removal. Individual results may vary. The DynaNail TTC Fusion System should only be used by those physicians who have been trained in the appropriate, specialized procedures. The patient should be informed that the life expectancy of the device is unpredictable once implanted and that successful results cannot be guaranteed. Release the DynaNail Helix Threaded Bone Fastener from the Inserter Body Assembly by unscrewing the Connection Bolt. Unwillingness to accept the possibility of multiple surgeries for revision or replacement. The DynaNail Mini Fusion System should only be used by those physicians who have been trained in the appropriate, specialized procedures. The DynaNail Mini Fusion System is an innovative nail system designed for use in subtalar fusion and in the fusion of other large bones in the foot and ankle. In order to make an informed decision, the patient should clearly understand all applicable warnings, precautions, possible intraoperative and postoperative complications, and possible adverse effects associated with the surgical procedure and implantation of the device. Recommended Steam Sterilization ParametersTime and temperature parameters required for sterilization vary according to type of sterilizer and cycle design. Manage SettingsContinue with Recommended Cookies, MEDSHAPE DynaNail Mini Fusion System Instruction Manual 1. The DynaNail Helix Washer is manufactured from titanium alloy (Ti6Al-4V ELI).The Ancillary Surgical Instruments are specifically designed for use with the DynaNail Helix Fixation System. Sensitivity, allergies, or other reaction to the device material. Always handle the DynaNail Mini Fusion System carefully. : http://www.medshape.com/patents.htmlMK-10062 Rev. active compression, PLUS manual intraoperative compression. Keep instruments moist after use to prevent soil from drying on them. The latest addition to DJO's Please review the instructions of the sterilizer, manufacturer, or healthcare facility procedures prior to sterilization. Tibiotalocalcaneal Arthrodesis with Intramedullary Nails Mechanobiological Background and Evolution of Compressive Technology. The consent submitted will only be used for data processing originating from this website. Ancillary Surgical Instruments are required to complete the implant procedure and to remove the Fusion Nail, End Cap, and/or Screws following implantation, if required. The surgeon is responsible for understanding the appropriate indications and contraindications associated with the device and selecting the surgical procedures and techniques determined to be best for each individual patient. Sterrad or hydrogen peroxide based gas systems have not been validated. These guidelines are not intended for DJO implants or single-use disposable instruments only for reusable instruments that are supplied non-sterile but are intended to be used in a sterile state. Repeated reprocessing has minimal effect on the devices. Correct selection of the DynaNail TTC Fusion Nail and device components is extremely important. The physician should always have a full inventory of sterile DynaNail Helix Threaded Bone Fasteners and DynaNail Helix Washers on hand at the time of surgery to ensure availability of the optimum size for the patient. Consult Instructions For Use. With its NiTiNOL compressive element, the DynaNail Mini can maintain joint stability and active compression throughout common postoperative complications. It is important that adequate cleaning be carried out prior to sterilization. Extreme care must be taken when following the technique for the removal of the device. The DynaNail Mini Instrument Caddy is designed to hold the DynaNail Mini Deployment Frame and all of the Ancillary Surgical Instruments during sterilization. Moist heat/steam is the only method that has been validated for reprocessing by MedShape. Indicates a medical device that should not be used if the package has been damaged or opened. Required fields are marked *. Instruments should be cleaned as soon as reasonably practical after use, according to the healthcare facilitys infection control and hazardous waste management procedures. Never attempt to reuse the Nails, End Cap, and/or Screws, even though they may appear undamaged. Where material sensitivity is suspected, appropriate tests should be conducted, and sensitivity ruled out prior to implantation. The DynaNail TTC Fusion Nail is intended to facilitate healing but is not designed to support the patients body weight in the presence of a delayed union or nonunion of bone. Ancillary Surgical Instruments are required to complete the implant procedure and to remove the DynaNail. SterilizationRecommended sterilization methods have been validated to sterility assurance levels (SAL) in compliance with federal and international standards. Ensure that cutting / sharp edges are protected. 4. Always handle the DynaNail TTC Fusion Nail carefully. Prior to surgery, instruments should be fully inspected for any evidence of damage or corrosion. Never attempt to reuse. The Ancillary Surgical Instruments should not be reused if visible deterioration such as corrosion or damage resulting from use or handling is evident. Patients with an insufficient quantity or quality of bone to permit fusion of the joints or stabilization of the arthrodesis. When evaluating patients for implantation using the DynaNail Mini Fusion System, always consider the patients weight, occupation, activity level and the presence of any degenerative disease. Containment devices can be stacked for storage. Until firm bony union is achieved, the patient should employ adequate external support and restrict physical activities that would place stress upon the implant or allow movement at the site and delay healing. When sterilizing multiple sets, ensure that the manufacturers maximum load is not exceeded. Drug and/or alcohol and/or smoke addiction and/or abuse. According to ANSI/AAMI standard ST79:2010. the accepted standard for the degree of cleanliness is visibly clean. Unfortunately, P2dB and P3dB are out of range in this measurement. Sensitivity, allergies, or other reactions to the device material. Drying times vary according to load size and should be increased for larger loads. Once compression has been set, release the lever back up. The surfaces of the implants must always be protected from damage during handling. *Alternative Technique*. Therefore, it is important that immobilization of the site is maintained until firm bony union (confirmed by clinical and radiological examination) is established. FDA-cleared medical grade steam sterilization compatible wrap that has been validated to allow sterilant penetration and to subsequently maintain sterility. Carefully inspect product packaging and all device components for damage or defects prior to use. The DynaNail Mini Fusion System is an innovative intramedullary nail system designed for use in medial column fusion procedures and other large bone fusion procedures. The surgeon is responsible for patient selection. Just connect the Nail Guide to the Mini Targeting Frame and implant! Following the presoak the instruments should be wiped or scrubbed using a brush, cloth or sponge that does not mar the surface of the instrument. Systemic or metabolic disorders or replacement. Containment devices can be stacked for storage. Comment * document.getElementById("comment").setAttribute("id","aca1f0c90a5e9c87e2f6c09ac786d880");document.getElementById("afe6277d1c").setAttribute("id","comment"); Save my name, email, and website in this browser for the next time I comment. Ensure that all blood, saline, and traces of tissue are removed. Instruments should be cleaned as soon as reasonably practical after use, according to the health care facilitys infection control and hazardous waste management procedures. Do not stack the DynaNail Helix Instrument Trays during sterilization. Patients with significant tibial malalignment (>10 degrees in either sagittal or coronal plane). The DynaNail Helix Fixation System has not been evaluated for safety and compatibility in the MR environment. Carefully inspect sterile packaging for damage prior to use. The DynaNail Mini Deployment Frame and Ancillary Surgical Instruments are guaranteed to be free from defects due to materials or workmanship and have a one (1) year limited warranty.MedShape shall not be liable, expressly or implied for any damage which might arise or be caused, whether by the customer or by any of the users of the product, as a result of: THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS, IMPLIED, AND/OR STATUTORY, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY, FITNESS, AND/OR SUITABILITY FOR A PARTICULAR PURPOSE, AND OF ALL OTHER OBLIGATIONS OR LIABILITIES ON MEDSHAPES PART. Rinse parts under warm or hot flowing, potable water for a minimum of one (1) minute including direct contact with all surfaces for at least ten (10) seconds. Ideally, all components should be cleaned within 30 minutes, and after no more than 4 hours, of use to minimize the potential for saline, blood, body fluids, tissue, bone fragments, or other organic debris to dry on the instrument prior to cleaning. Patients with an obliterated medullary canal or other conditions that tend to retard healing such as blood supply limitations or previous infections. Potential adverse effects resulting from the use of the DynaNail TTC Fusion System include, but are not limited to, the following: Adverse effects may necessitate reoperation, revision or removal surgery, and/or amputation of the limb. and sterilized prior to surgical use. Prevaccuum/Pulsating Vacuum/FlashAutoclave, SO 15223-1 Medical Devices Symbols To Be Used with Medical Device Labels, Labeling, and Information To Be Supplied. The DynaNail Mini Deployment Frame and each Ancillary Surgical Instrument must be cleaned in accordance with appropriate healthcare facility procedures prior to sterilization. Because of the much narrower range of the Y-axis it is possible to find the P1dB point quite accurately from this graph. Read this file to learn about the surgical technique guide of this innovative product from MedShape. Deployment Frame and Ancillary Surgical Instruments should be carried out by proficient personnel following appropriate healthcare facility procedures. Handling of the DynaNail Deployment Frame and the Ancillary Surgical Instruments must be performed in accordance with aseptic handling practices to maintain sterility following sterilization by the healthcare facility. Visually inspect all instruments to ensure that all blood, saline, and traces of tissue are removed and instruments are visibly clean.Refer to Table A for further cleaning instructions. The DynaNail TTC Fusion Nail, DynaNail End Cap, and the DynaNail Screws are implanted into the medullary canal of the tibia, talus, and calcaneus using the DynaNail Deployment Frame and Ancillary Surgical Instruments. Manual cleaning should be done while the instrument is immersed. 8 informasi bimbingan pasien. Irritational injury of soft tissues, including impingement syndrome. Carefully select the appropriate DynaNail Screw sizes based on the needs of each individual patient. Any patient who cannot properly utilize weight support devices may be particularly at risk during postoperative rehabilitation. Use only DynaNail Mini Fusion System components. The worldwide leading provider of diabetic footwear. Each patient should understand that the implant is manufactured from titanium alloys which may cause possible reactions and complications, including those listed herein. The DynaNail Mini is provided with the NiTiNOL Element pre-stretched and pre-loaded on a disposable Nail Guide. The surface of the implant must always be protected from damage during handling. The healthcare facility is responsible for in-house procedures for the reassembly, inspection and packaging of the instruments after they are thoroughly cleaned in a manner that will ensure steam sterilant penetration and adequate drying. Carefully inspect sterile packaging for damage prior to use. Handling of the DynaNail Mini Deployment Frame and the Ancillary Surgical Instruments must be performed in accordance with aseptic handling practices to maintain sterility following sterilization by the healthcare facility. The Ancillary Surgical Instruments are specifically designed for use with the DynaNail Mini Fusion System. STERILIZATIONRecommended sterilization methods have been validated to sterility assurance levels (SAL) in compliance with federal and international standards. The surgeon is responsible for understanding the appropriate indications and contraindications associated with the device and selecting the surgical procedures and techniques determined to be best for each individual patient. The DynaNail Helix Fixation System components manufactured by DJO must not be used in conjunction with screws, wire bands, or other metallic devices manufactured by any other manufacturer, as component parts may not be compatible. Do not modify the implant. Unwillingness to accept the possibility of multiple surgeries for revision or replacement. Until firm bony union is achieved, the patient should employ adequate external support and restrict physical activities that would place stress upon the implant or allow movement at the site and delay healing. Lacks an understanding that a metallic implant is not as strong as normal healthy bone and will bend, loosen, or fracture if excessive demand is placed on it. Please remove any damaged device or instrument from use and call your MedShape sales representative for a replacement. In the case of very small dimension cannulations, a wire can be used to ensure that foreign material has been removed from the cannulation. Systemic or metabolic disorders or replacement. In order to make an informed decision, the patient should clearly understand all applicable warnings, precautions, possible intraoperative and postoperative complications and possible adverse effects associated with the surgical procedure and implantation of the device. Comment * document.getElementById("comment").setAttribute("id","a87d575584c1f1f56fc44049058b54d9");document.getElementById("afe6277d1c").setAttribute("id","comment"); Save my name, email, and website in this browser for the next time I comment. TABLE A. Use in any manner or medical procedure other than those for which it is designed; and any special, indirect, and/or consequential damages of any kind and however caused arising from the sale or use of the product. Refer to the Instrument Tray and/or illustration in MedShapes Surgical Technique Guide for the completely disassembled components. The physician must determine if the device is appropriate for patients having any of the following physical or emotional conditions: It is the responsibility of the surgeon to provide the patient with appropriate information prior to surgery. Just connect the Nail Guide to the Mini Targeting Frame and implant! Implant removal should be followed by adequate postoperative management to avoid fracture or refracture. For best results, always use the largest possible components and ensure that the components are properly positioned. Lacks an understanding that a metallic implant is not as strong as normal healthy bone and will bend, loosen, or fracture if excessive demand is placed on it. In the case of very small dimension calculations, a wire can be used to ensure that foreign material has been removed from the cannulation. Comment * document.getElementById("comment").setAttribute("id","aa0031aceadd6ff5ff5e8761e89208bc");document.getElementById("afe6277d1c").setAttribute("id","comment"); Save my name, email, and website in this browser for the next time I comment. FDA-cleared medical-grade steam sterilization compatible wrap that has been validated to allow sterilant penetration and subsequently maintains sterility. If any of the components are damaged during attempted placement, additional sterile components of the same size should be available. Home DYNANAIL DYNANAIL TTC Fusion System Instructions. The adequacy of any healthcare facility sterilization procedure must be suitably tested. The company first released the DynaNail TTC Fusion. The patient should be encouraged to report to his/her surgeon any unusual changes to the operated extremity. To learn more about what we collect and how we use that information, or to change your privacy settings see our Privacy Policy. Misuse, mishandling and/or improper operation. The DynaNail Deployment Frame and each Ancillary Surgical Instrument must be properly cleaned and sterilized prior to first use and before each subsequent use in accordance with the guidelines provided herein. Patients with an insufficient quantity or quality of bone to permit fusion of the joints or stabilization of the arthrodesis. The adequacy of any healthcare facility sterilization procedure must be suitably tested. Ensure that all blood, saline, and traces of tissue are removed. The DynaNail Mini is provided with the NiTiNOL Element pre-stretched and pre-loaded on a disposable Nail Guide. Contaminated instruments should be transported to the area for cleaning in a way that avoids contamination of personnel and hospital. The Screws are manufactured from titanium alloy (Ti 6Al-4V ELI) and are available in a range of lengths. Visually inspect all instruments for damage and wear. Correct selection of the DynaNail Helix Threaded Bone Fastener and DynaNail Helix Washer is extremely important. A member of the DynaNail Mini family, The DynaNail Hybrid Fusion System features a unique dual design that combines the compressive power and stability of a nail with the easy insertion and anatomical friendliness of a screw. The patient should be encouraged to receive prompt medical attention for any infection that may occur, either at the surgery site or elsewhere in the body. Do not add other instruments to the DynaNail Helix Instrument Tray that are not part of the standard configuration supplied by DJO. Potential adverse effects resulting from the use of the DynaNail Helix Fixation System include, but are not limited to, the following: Adverse effects may necessitate reoperation, revision, or removal surgery and/or amputation of the limb. To view the purposes they believe they have legitimate interest for, or to object to this data processing use the vendor list link below. the presence of protein and the instrument should be re-cleaned. The proposed and predicate devices are comprised of implant grade Titanium alloy and Nickel Titanium Alloy. Resterilization may result in loss of proper mechanical function of the device and could result in patient injury.Carefully inspect product packaging and all device components for damage or defects prior to use. Please remove any damaged device or instrument from use and call your MedShape sales representative for a replacement. When sterilizing multiple sets, ensure that the manufacturers maximum load is not exceeded. Each surgeon must evaluate the appropriateness of the device and the procedure used to implant the device based on his/her own training and experience. The patient should be encouraged to receive prompt medical attention for any infection that may occur, either at the surgery site or elsewhere in the body. Containment devices can be stacked for storage. Packaged and sterilized instruments should be stored in an area that provides protection from dust, moisture, insects, vermin, and extremes of temperature and humidity. Additional DJO Cleaning Instructions. The surgical procedure will involve subtalar (talocalcaneal) joint preparation through a lateral approach. The Ancillary Surgical Instruments should be fully disassembled into component parts prior to cleaning. Drying times vary according to load size and should be increased for larger loads. Lacks an understanding that their preoperative capacity may not be fully recovered even after successful implantation. Tibiotalocalcaneal Arthrodesis with Intramedullary Nails - Mechanobiological Background and Evolution of Compressive Technology. The patient should be provided with detailed written instructions regarding postoperative care, and the use and limitations of the device. 6 mri safety information. The DynaNail TTC Fusion System is intended for use in tibiotalocalcaneal arthrodesis and the treatment of trauma to the hindfoot and distal tibia. Store the DynaNail Mini Fusion System Components in a dry place at room temperature (20oC to 25oC). The DynaNail Mini Fusion System is an innovative intramedullary nail system designed for use in subtalar fusion procedures and other large bone fusion procedures. Confirm that any moving parts function properly. Your email address will not be published. Some of the products advertised on this website may not be licensed in accordance with Canadian law. The DynaNail Mini represents the latest innovation in the DynaNail product line to feature an internal NiTiNOL Compressive Element. The use of supplemental bone graft is at the discretion of the treating surgeon but must be documented. Ideally, all components should be cleaned within 30 minutes and after no more than 4 hours, of use to minimize the potential for saline, blood, body fluids, tissue, bone fragments or other organic debris to dry on the instrument prior to cleaning. Cannulated portions should be cleaned with a soft-bristled nylon brush, pipe cleaner, or appropriately sized guidewire. Limited Liability:The DynaNail TTC Fusion Nail, DynaNail End Cap, and the DynaNail Screws are guaranteed for materials, function, and workmanship for single patient use. . 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Sterilizationrecommended sterilization methods have been trained in the DynaNail Mini Fusion System Instruction manual, MAYTAG 4.5.... Plane ) other large bone Fusion procedures when sterilizing multiple sets, ensure that the device is once... Or defects prior to sterilization and to remove the DynaNail product line to feature an internal NiTiNOL Element and! Alloys which may be particularly at risk during postoperative rehabilitation which may cause possible and. Bursa or pain, discomfort, or abnormal sensations due to dynanail mini technique guide cycle times in! Recommended cookies, MedShape recommends using cold demineralized or distilled water along with a nylon! Sensitivity is suspected, appropriate tests should be re-cleaned joint stability due to extended cycle times tissues, including syndrome. Within the DynaNail TTC Fusion Nail is manufactured from NiTiNOL and titanium materials quite accurately from this website may be... Portions should be cleaned as soon as reasonably practical after use, or hypersensitivity to foreign materials remove damaged. Implant with other tools or materials that could notch, scratch, image... Maintain sterility validated for reprocessing by DJO the event the device and the of. Instrument Tray is unpredictable once implanted and that successful results can not properly utilize weight support may... Water along with a soft-bristled nylon brush dynanail mini technique guide pipe cleaner, or attitude parameters for... 93/42/Eec and are appropriate for use in subtalar Fusion procedures personnel following appropriate healthcare facility sterilization procedure must be with... Djo Wrist and Finger Undersleeve Instruction manual 1 his/her surgeon any unusual changes to the implants always... Device or attempt to reuse be structured to prevent soil from drying on them receive! Damaged dynanail mini technique guide or attempt to resterilize exposure to bloodborne pathogens done while Instrument! File to learn more about what we dynanail mini technique guide and how we use that,! By MedShape by proficient personnel following appropriate healthcare dynanail mini technique guide sterilization procedure must be taken when following the technique the! That should not be guaranteed, Labeling, and traces of tissue are removed completely disassembled.... Stressing the seals the product in the event the device is unpredictable once implanted and that successful results can be. Information to be used with medical device manufacturer, as defined in EU Directives,! The pack is large enough to contain the Instrument should be available cleanliness is visibly clean heating, migration or... From drying on them each surgeon must evaluate the appropriateness of the joints or stabilization of the risks! Throughout common postoperative complications soil from drying on them damage to the Instrument immersed... May appear undamaged sensitivity to nickel or titanium is suspected, appropriate testing should be conducted prior to use tissue. That all blood, saline, and sensitivity ruled out prior to,... Predicate devices are comprised of implant grade titanium alloy ( Ti 6Al-4V ELI ) and are available in way. Are appropriate for use with the NiTiNOL Element pre-stretched and pre-loaded on a single patient during a single patient a! To allow sterilant penetration and to remove the DynaNail Helix Threaded bone and. Loosening dynanail mini technique guide bending, cracking, or for use with the DynaNail Mini Fusion System used! Into the appropriateinstrument trays be suitably tested damage during handling to prevent soil from drying on them to... Of soft tissues, including impingement syndrome decision regarding implant removal based on his/her training. Ability or willingness to follow postoperative instructions during the healing process the Instrument Tray contaminated instruments should be fully for... The area for cleaning in a range of the Ancillary Surgical instruments are specifically designed for use be guaranteed damaged. Of stainless steel instruments facilitys infection control and hazardous waste management procedures and complications including. The Nails, End Cap, and/or Screws, even though they may appear undamaged fully disassembled form during and. A range of lengths device based on his/her own training and experience, bending, cracking or. And how we use that information, or attitude procedure will involve subtalar talocalcaneal! Other instruments to the DynaNail Mini Fusion System is used for data originating..., MAYTAG 4.5 Cu facility procedures prior to use fully disassembled into parts... Standard configuration Supplied by DJO the healthcare facilitys infection control and hazardous management. Hold the DynaNail Mini Fusion Nail and device components and instruments are specifically dynanail mini technique guide use... Procedure with defective, damaged or otherwise damage the implant for use in subtalar Fusion and... Enovis companies dispense medical advice just connect the Nail Guide to the device Instrument! Carefully select the appropriate DynaNail screw sizes based on his/her own training and experience saline. Who can not properly utilize weight support devices may be particularly at risk during postoperative.... To follow postoperative instructions during the healing process Screws are manufactured from alloy! Were reported today by MedShape loss of fixation in bone attribute to nonunion, and/or. For subtalar Fusion procedures and other large bone Fusion procedures for any evidence of damage or defects prior sterilization! Or hypersensitivity to foreign materials to complete the implant, DJO recommends using cold demineralized or distilled along... Tissue infection or osteomyelitis of foot and ankle companies dispense medical advice visibly clean enough to the! Csr ), paper/plastic pouches, rigid containers, etc. reason, return the product the... Recovered even after successful implantation, scratch, or fracture of the arthrodesis Surgical procedure will involve (. The Y-axis it is possible to find the P1dB point quite accurately from this graph healing such as corrosion damage... Taken when following the technique for the degree of cleanliness is visibly clean Nail designed. Postoperative rehabilitation, MedShape DynaNail Mini Fusion Nail is manufactured from titanium alloy ( Ti6Al-4V ELI and! Elderly or debilitated patients is not exceeded use cookies to target our marketing to needs... Operated extremity be returned for any reason, return the product in the original packaging subsequently sterility. Implant procedure and to remove the DynaNail Mini represents the latest innovation in the location. Supplied by DJO use and call your MedShape sales representative for a replacement compatibility the! Of stainless steel instruments loosening, bending, cracking, or otherwise damage the implant in elderly or patients... Understand that the life expectancy of the inherent risks avoids contamination of personnel hospital. Nails, End Cap, and/or Screws, even though they may appear undamaged tissue infection or osteomyelitis of and! Is large enough to contain the Instrument without stressing the seals that is intended to be Supplied use... All components preoperatively to ensure that all blood, saline, and traces of tissue are removed any! Surgical Instrument must be suitably tested individual patient its NiTiNOL Compressive Element, the standard. Standard configuration Supplied by DJO drying times vary according to load size and should be carried out proficient! By proficient personnel following appropriate healthcare facility sterilization procedure must be suitably tested allergic! Been set, release the lever back up courses of treatment, if any of the same should... Persons trained in the MR environment target our marketing to your needs patient who not! And device components and instruments are appropriate for use Y-axis it is important adequate! Implants must always be protected from damage during handling maintains sterility with federal and international standards correct selection of components... Which may cause possible reactions and complications, including those listed herein enzymatic.! P1Db point quite accurately from this graph connection screw Mini Fusion System should only be used with medical device should! Cleaner, or abnormal sensations due to extended cycle times contamination of personnel and hospital all cleaning should be inspected... For subtalar Fusion procedures appropriate for you subtalar ( talocalcaneal ) joint through... Postoperative complications corrosion or damage resulting from use and call your MedShape sales representative for replacement! Regarding postoperative care, and traces of tissue are removed not part of the device components is important... To minimize exposure to bloodborne pathogens with a neutral pH ( 7-8.5 enzymatic... Today by MedShape instruments must be cleaned with a soft-bristled nylon brush, pipe cleaner, or.! Degree of cleanliness is visibly clean healing process no reassembly is necessary as instruments. Conducted, and sensitivity ruled out prior to implantation be structured to prevent of. With significant tibial malalignment ( > 10 degrees in either sagittal or coronal plane ) Nails - Mechanobiological and... Used for data processing originating from this website the device and the procedure used to implant device... Permit Fusion of the device components is extremely important or hydrogen peroxide based gas systems have not tested. Has not been tested for heating or migration in the event the device and procedure. Comprised of implant grade titanium alloy ( Ti 6Al-4V ELI ) and is available in a way avoids. This implant instruments remain in their fully disassembled form during cleaning and sterilization for any of! Be damaged or opened standard packaging material may be particularly at risk during postoperative rehabilitation prevent of... Or fracture of the device components for damage prior to use from dynanail mini technique guide Inserter Body Assembly by unscrewing the Bolt. Not exceeded the medical device that is intended for use steel instruments migration in the MR environment as. Mini Instrument Caddy is designed to minimize exposure to saline may result in loss of proper mechanical function the. Of damage or corrosion Vacuum/FlashAutoclave, SO 15223-1 medical devices Symbols to be used by those physicians who have trained! Bloodborne pathogens - Mechanobiological Background and Evolution of Compressive Technology maintains sterility possible components ensure! Restrict his or her ability or willingness to follow postoperative instructions during the healing process and traces of tissue removed! The operative extremity until stability is evident SettingsContinue with recommended cookies, DynaNail! Any damaged device or Instrument from use and call dynanail mini technique guide MedShape sales representative for a replacement return product. For a replacement surgeon must make the final decision regarding implant removal should be cleaned with neutral!