Da Vinci Tibial Nail System Instructions for Use

2 Pages

EN AOS DA VINCI™ TIBIAL NAIL SYSTEM    INSTRUCTIONS FOR USE Federal Law restricts this device to sale by or on the order of a physician DEVICE DESCRIPTION The AOS DA VINCI™ TIBIAL NAIL SYSTEM consists of intramedullary nails of varying length and diameters and with cross locking holes to accommodate varying sizes of locking screws... he intramedullary nails and screws are manufactured from titanium alloy... HE AOS DA VINCI™ TIBIAL NAILS are intramedullary nails in lengths of 27cm to 39cm... or the nails with working diameters of 8mm, 9mm, 10mm, and11mm, the proximal diameter is 11... m... or the 12mm and 13mm diameter nails, the diameter is throughout the length... he nails have a proximal bend of 10°, and the distal end has a 3° bend... he proximal portion has two holes and one slot designed to accept a 5... m cortical screw... he distal end of the nail has three holes with the 9mm, 10mm, 11mm, 12mm, and 13mm diameter nails accepting 5... m cortical screws and the 8mm diameter nail accepting 4... m screws... he proximal end of the nail is threaded to accept an end cap and/or a static locking spacer... he system is provided in a dedicated sterilization tray and includes an accompanying set of instruments... NDICATIONS FOR USE The AOS DA VINCI™ TIBIAL NAIL SYSTEM is intended to provide temporary stabilization of various types of fractures, malunions, and nonunions of the tibia... he AOS DA VINCI™ TIBIAL NAIL SYSTEM is indicated for long bone fracture fixation of tibial fractures, which may include the following: transverse, oblique, spiral, segmental, and comminuted fractures; fractures with bone loss and bone transport; open and closed fractures, pathologic fractures; corrective osteotomies; pseudarthrosis of the tibial shaft; non-unions, malunions, metaphyseal and epiphyseal fractures... ONTRAINDICATIONS 1... atients with an active superficial infection... ediatric patients, or patients with skeletal immaturity... atients with a history of frequent infections... atients with known sensitivity or allergies to the implant materials... atients with neuromuscular deficiencies in the affected limb sufficient to render the procedure unwarranted... onditions that preclude cooperation with the rehabilitation regimen for postoperative care or impair the patient's ability to follow directions... hysical conditions that would preclude adequate implant support or retard healing, such as blood supply impairment in the treated area, obliterated medullary canal, insufficient bone quality or quantity, previous infection, or obesity... ARNINGS The AOS DA VINCI™ TIBIAL NAIL SYSTEM must be sterilized prior to use... lease refer to the section on STERILIZATION below... he AOS DA VINCI™ TIBIAL NAIL SYSTEM is intended for use by individuals with adequate training and familiarity with techniques associated with the orthopedic surgical procedure employed... or further information about techniques, complications, and hazards, consult the medical literature... lease refer to the AOS Da Vinci™ Tibial Nail System Surgical Technique (PN 9018) for additional information on the use of the AOS DA VINCI™ TIBIAL NAIL SYSTEM... age 1 of 2  The implants of the AOS DA VINCI™ TIBIAL NAIL SYSTEM are for single use only... euse of the devices is associated with risks for the transmission of infectious diseases and loss of mechanical strength... hile the device may appear undamaged, previous stress may have created imperfections and internal stress patterns which could lead to implant failure... se care in storage and handling of devices... hile in storage, device components should be protected from corrosive environments such as salt air, moisture, etc... hile handling device components, do not apply excessive force to implants, as cutting, bending, or scratching the surface of device components can reduce their strength and fatigue resistance... nspect all device components for damage prior to surgery... eplace damaged or worn components, as necessary... or proper care and handling of AOS REUSABLE INSTRUMENTS and AOS SINGLE USE INSTRUMENTS, please refer to their package insert (IFU-9000)... RI SAFETY INFORMATION Non-clinical testing has demonstrated that AOS DA VINCI™ TIBIAL NAIL SYSTEM implants are MR Conditional...  patient with these devices can be safely scanned in an MR system meeting the following conditions: 1... tatic magnetic field of 1... Tesla (1... T) or 3-Tesla (3 T)... aximum spatial field gradient of 2,670 G/cm (26... T/m)... hen scanning in a 1... T scanner, patients implanted in the tibia can be scanned with a whole-body averaged SAR of 2... W/kg (Normal Operating Mode) when landmarked superior to the distal femur for a maximum scan time of 15 minutes... canning is not permitted at landmark locations inferior to the distal femur... hen scanning in a 3 T scanner, patients implanted in the can be scanned with a whole-body averaged SAR of 2... W/kg (Normal Operating Mode) for landmark locations superior to the distal femur and below the distal tibia for a maximum scan time of 15 minutes... therwise, the whole-body SAR needs to be limited to 1... W/kg or less for a maximum scan time of 15 minutes... he scanner SAR restrictions above apply to a circularly polarized wholebody RF coil... or other RF coil types (e... , extremity, head, neck), appropriate whole-body SAR restrictions should be considered to ensure similar levels of localized SAR are achieved... F HEATING Under the scan conditions defined above, AOS DA VINCI™ TIBIAL NAIL SYSTEM implants are expected to produce a maximum temperature rise less than or equal to 5... ºC after 15 minutes of continuous scanning... R ARTIFACT In non-clinical testing, the image artifact caused by AOS DA VINCI™ TIBIAL NAIL SYSTEM implants extend radially approximately 4... cm from the device... OSSIBLE ADVERSE EVENTS 1... erve or soft tissue damage, necrosis of bone or bone resorption, necrosis of the tissue, or inadequate healing from surgical trauma or presence of implant... ascular disorders including thrombophlebitis, pulmonary emboli, wound hematomas, and avascular necrosis of the femoral head... etal sensitivity or histological or allergic reaction to device materials... rritation injury of soft tissues, including impingement syndrome... ain, discomfort, or abnormal sensations... nfections, both deep and superficial... one damage or refracture... IRECTIONS FOR USE PREOPERATIVE Inspect all AOS DA VINCI™ TIBIAL NAIL SYSTEM implant components under adequate lighting prior to sterilization for wear or damage that would impact its performance... f wear or damage is identified, component parts should be discarded and replaced... n image intensifier and an appropriate fracture table are required to perform this surgery... FU-9010 / AC May 2021   Allergies and other reactions to device materials should be ruled out preoperatively... NTEROPERATIVE Select the most appropriate implant size suitable for the patient's age, weight, and bone quality... se the largest implant suitable for the patient to prevent loosening, migration, bending, cracking, or fracture of the device or bone or both...  stable construct should be achieved and verified under image intensification... OSTOPERATIVE The AOS DA VINCI™ TIBIAL NAIL SYSTEM is not designed to withstand the stress of weight-bearing, load-bearing, or excessive activity... aution patients against unassisted activity that requires walking, to reduce the likeliness of weight bearing on the affected limb during treatment... evice breakage or damage can occur when the implant is subjected early weight-bearing or increased loading associated with delayed union, nonunion, or incomplete healing... nternal or external supports may be utilized to minimize internal stress loading of the implant and broken bone until solid bony union is evident by radiograph... eriodic x-ray examinations for at least the first six (6) months postoperatively are recommended for close comparison with postoperative conditions to detect changes in position, non-union, loosening, bending, or cracking of components... he AOS DA VINCI™ TIBIAL NAIL SYSTEM may be removed after treatment... n the absence of pain, removal of the implant in elderly or debilitated patients is not suggested... STERILIZATION The AOS DA VINCI™ TIBIAL NAIL SYSTEM must be sterilized by the following process parameters... hey should be removed from their original packaging and labeling and placed within the appropriate sterilization tray... he sterilization tray should be wrapped in an FDA cleared protective wrapping... o not stack sterilization trays... he following process parameters have been validated for the sterilization of the AOS trays, implants, and instruments... he recommended drying time is 30 minutes... Method Cycle Steam Pre-Vacuum  Temperature 270 °F (132 °C)  Exposure Time 4 minutes  The sterilization process complies with the requirements of ISO 17665 1, in accordance with AAMI TIR 12 and ANSI/AAMI ST77 and has been validated to a sterility assurance level of 10-6 CFU... INFORMATION For further information please contact Advanced Orthopaedic Solutions at 310-533-9966... SYMBOL GLOSSARY  Part number (catalog number)  Lot number (batch code)  Quantity  Material   Caution   Consult instructions for use   Manufacturer   Date of manufacture    Expiration date   Do not reuse   Sterilized using irradiation  Do not resterilize  Non-sterile product  MR Conditional  Do not use if package is damaged  Authorized Representative in the European Community  Page 2 of 2    Advanced Orthopaedic Solutions, Inc... 203 Kashiwa Street Torrance, CA 90505 USA Phone: 310-533-9966 Email: regaffairs@aosortho... m  IFU-9010 / AC May 2021
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