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. The intramedullary nails and screws are manufactured from titanium alloy. THE AOS DA VINCI™ TIBIAL NAILS are intramedullary nails in lengths of 27cm to 39cm. For the nails with working diameters of 8mm, 9mm, 10mm, and11mm, the proximal diameter is 11.5mm. For the 12mm and 13mm diameter nails, the diameter is throughout the length. The nails have a proximal bend of 10°, and the distal end has a 3° bend. The proximal portion has two holes and one slot designed to accept a 5.0mm cortical screw. The distal end of the nail has three holes with the 9mm, 10mm, 11mm, 12mm, and 13mm diameter nails accepting 5.0mm cortical screws and the 8mm diameter nail accepting 4.2mm screws. The proximal end of the nail is threaded to accept an end cap and/or a static locking spacer. The system is provided in a dedicated sterilization tray and includes an accompanying set of instruments. INDICATIONS 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. The 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. CONTRAINDICATIONS 1. Patients with an active superficial infection. 2. Pediatric patients, or patients with skeletal immaturity. 3. Patients with a history of frequent infections. 4. Patients with known sensitivity or allergies to the implant materials. 5. Patients with neuromuscular deficiencies in the affected limb sufficient to render the procedure unwarranted. 6. Conditions that preclude cooperation with the rehabilitation regimen for postoperative care or impair the patient's ability to follow directions. 7. Physical 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. WARNINGS The AOS DA VINCI™ TIBIAL NAIL SYSTEM must be sterilized prior to use. Please refer to the section on STERILIZATION below. The 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. For further information about techniques, complications, and hazards, consult the medical literature. Please 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. Page 1 of 2
The implants of the AOS DA VINCI™ TIBIAL NAIL SYSTEM are for single use only. Reuse of the devices is associated with risks for the transmission of infectious diseases and loss of mechanical strength. While the device may appear undamaged, previous stress may have created imperfections and internal stress patterns which could lead to implant failure. Use care in storage and handling of devices. While in storage, device components should be protected from corrosive environments such as salt air, moisture, etc. While 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. Inspect all device components for damage prior to surgery. Replace damaged or worn components, as necessary. For proper care and handling of AOS REUSABLE INSTRUMENTS and AOS SINGLE USE INSTRUMENTS, please refer to their package insert (IFU-9000). MRI SAFETY INFORMATION Non-clinical testing has demonstrated that AOS DA VINCI™ TIBIAL NAIL SYSTEM implants are MR Conditional. A patient with these devices can be safely scanned in an MR system meeting the following conditions: 1. Static magnetic field of 1.5-Tesla (1.5 T) or 3-Tesla (3 T). 2. Maximum spatial field gradient of 2,670 G/cm (26.7 T/m). 3. When scanning in a 1.5 T scanner, patients implanted in the tibia can be scanned with a whole-body averaged SAR of 2.0 W/kg (Normal Operating Mode) when landmarked superior to the distal femur for a maximum scan time of 15 minutes. Scanning is not permitted at landmark locations inferior to the distal femur. 4. When scanning in a 3 T scanner, patients implanted in the can be scanned with a whole-body averaged SAR of 2.0 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. Otherwise, the whole-body SAR needs to be limited to 1.0 W/kg or less for a maximum scan time of 15 minutes. The scanner SAR restrictions above apply to a circularly polarized wholebody RF coil. For other RF coil types (e.g., extremity, head, neck), appropriate whole-body SAR restrictions should be considered to ensure similar levels of localized SAR are achieved. RF 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 5.9 ºC after 15 minutes of continuous scanning. MR ARTIFACT In non-clinical testing, the image artifact caused by AOS DA VINCI™ TIBIAL NAIL SYSTEM implants extend radially approximately 4.1 cm from the device. POSSIBLE ADVERSE EVENTS 1. Nerve or soft tissue damage, necrosis of bone or bone resorption, necrosis of the tissue, or inadequate healing from surgical trauma or presence of implant. 2. Vascular disorders including thrombophlebitis, pulmonary emboli, wound hematomas, and avascular necrosis of the femoral head. 3. Metal sensitivity or histological or allergic reaction to device materials. 4. Irritation injury of soft tissues, including impingement syndrome. 5. Pain, discomfort, or abnormal sensations. 6. Infections, both deep and superficial. 7. Bone damage or refracture. DIRECTIONS 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. If wear or damage is identified, component parts should be discarded and replaced. An image intensifier and an appropriate fracture table are required to perform this surgery. IFU-9010 / AC May 2021
Allergies and other reactions to device materials should be ruled out preoperatively. INTEROPERATIVE Select the most appropriate implant size suitable for the patient's age, weight, and bone quality. Use the largest implant suitable for the patient to prevent loosening, migration, bending, cracking, or fracture of the device or bone or both. A stable construct should be achieved and verified under image intensification. POSTOPERATIVE The AOS DA VINCI™ TIBIAL NAIL SYSTEM is not designed to withstand the stress of weight-bearing, load-bearing, or excessive activity. Caution patients against unassisted activity that requires walking, to reduce the likeliness of weight bearing on the affected limb during treatment. Device breakage or damage can occur when the implant is subjected early weight-bearing or increased loading associated with delayed union, nonunion, or incomplete healing. Internal 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. Periodic 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. The AOS DA VINCI™ TIBIAL NAIL SYSTEM may be removed after treatment. In 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. They should be removed from their original packaging and labeling and placed within the appropriate sterilization tray. The sterilization tray should be wrapped in an FDA cleared protective wrapping. Do not stack sterilization trays. The following process parameters have been validated for the sterilization of the AOS trays, implants, and instruments. The 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)
Consult instructions for use
Date of manufacture
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. 3203 Kashiwa Street Torrance, CA 90505 USA Phone: 310-533-9966 Email: [email protected]
IFU-9010 / AC May 2021