ADVANCED ORTHOPAEDIC SOLUTIONS

ANTEGRADE FEMORAL NAIL, RIGHT 13mm x 44cm

Magellan Femoral Nail System Instructions for Use

3 Pages

EN fractures, bone lengthening, fractures proximal to a total knee arthroplasty or prosthesis, fractures distal to a hip joint, non-unions and malunions, and fractures resulting from osteoporosis. CONTRAINDICATIONS  AOS MAGELLAN FEMORAL NAIL SYSTEM     INSTRUCTIONS FOR USE  Federal Law restricts this device to sale by or on the order of a physician DEVICE DESCRIPTION The AOS MAGELLAN FEMORAL NAIL SYSTEM is comprised of the AOS MAGELLAN ANTEGRADE FEMORAL NAIL, the AOS MAGELLAN RETROGRADE NAIL, and the AOS MAGELLAN ES™ RETROGRADE NAIL. These devices are all titanium alloy open reduction and internal fixation intramedullary nails and screws. The nails are cannulated through their entire length, and accepts 5.0mm, 6.0mm and 6.5mm interlocking screws. The AOS ANTEGRADE FEMORAL NAIL proximal screw holes accept 6.5mm fully threaded screws or 6.0mm partially threaded cancellous screws. The proximal slot accepts a 5.0mm cortical screw. All distal screw holes accept 5.0mm cortical screws. All nails have a proximal diameter of 13mm (14mm for the 14mm nail) with distal diameters available from 9mm to 14mm. The nails are available in lengths of 30cm to 46cm in 2cm increments. The proximal end of the nail is threaded to accept an end cap. The system is provided in a dedicated sterilization tray and includes an accompanying set of instruments. The AOS RETROGRADE FEMORAL NAIL distal screw holes and slot accept 6.5mm fully threaded screws or 6.0mm partially threaded cancellous screws. The proximal screw holes accept 5.0mm cortical screws. All nails have a distal diameter of 13mm, with proximal diameters available from 10mm to 13mm. The nails are available in lengths of 30cm to 46cm in 2cm increments. The supracondylar retrograde nails are available in 22cm length. All retrograde nails are threaded on the distal end to accept an end cap. The system is provided in dedicated sterilization tray and includes an accompanying set of instruments. INDICATIONS FOR USE The AOS ANTEGRADE FEMORAL NAIL is intended for use in intramedullary fixation of fractures of the femur to include the following: open and closed femoral fractures, pseudoarthrosis and correction osteotomy, pathologic fractures, impending pathologic fractures, and tumor resections, supracondylar fractures, including those with severe comminution and intraarticular extension, ipsilateral femur fractures, bone lengthening, fractures proximal to a total knee arthroplasty or prosthesis, fractures distal to a hip joint, nonunions and malunions, fractures resulting from osteoporosis. The AOS RETROGRADE FEMORAL NAIL is intended for use in intramedullary fixation of fractures of the femur to include the following: open and closed femoral fractures, pseudoarthrosis and correction osteotomy, pathologic fractures, impending pathologic fractures, and tumor resections, supracondylar fractures, including those with severe comminution and intraarticular extension, ipsilateral femur fractures, bone lengthening, fractures proximal to a total knee arthroplasty or prosthesis, fractures distal to a hip joint, nonunions and malunions, and fractures resulting from osteoporosis. The AOS ES™ RETROGRADE FEMORAL NAIL is intended for use in intramedullary fixation of fractures of the femur to include the following: open and closed femoral fractures, pseudoarthrosis osteotomy, correction osteotomy, pathologic fractures and impending pathologic fractures, tumor resections, supracondylar fractures, including those with severe comminution and intra- articular extension, ipsilateral femur Page 1 of 3  1. Patients with an active superficial infection. 2. Pediatric patients, or patients with skeletal immaturity. 3. Patients with shaft fractures should not be treated with the AOS ES™ RETROGRADE FEMORAL NAIL. 4. Patients with a history of frequent infections. 5. Patients with known sensitivity or allergies to the implant materials. 6. Patients with neuromuscular deficiencies in the affected limb sufficient to render the procedure unwarranted. 7. Conditions that preclude cooperation with the rehabilitation regimen for postoperative care or impair the patient's ability to follow directions. 8. 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 MAGELLAN FEMORAL NAIL SYSTEM must be sterilized prior to use. Please refer to the section on STERILIZATION below. The AOS MAGELLAN FEMORAL 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 Magellan Femoral Nail System Surgical Technique (Antegrade: PN 9076, Retrograde and ES™ PN 9077) for additional information on the use of the AOS MAGELLAN FEMORAL NAIL SYSTEM. The implants of the AOS MAGELLAN FEMORAL 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 MAGELLAN FEMORAL NAIL SYSTEM implants are MR Conditional. A patient with these devices can be safely scanned in an MR system meeting the following conditions: 1. 2. 3.  Static magnetic field of 1.5-Tesla (1.5 T) or 3-Tesla (3 T). Maximum spatial field gradient of 2,670 G/cm (26.7 T/m). When scanning in a 1.5 T scanner, patients can be scanned with a whole-body averaged SAR of 2.0 W/kg (Normal Operating Mode) when landmarked superior to the hip for a maximum scan time of 15 minutes. If scanning is performed between below the hip, the wholebody SAR needs to be limited to 1.0 W/kg or less for a maximum scan time of 15 minutes. 4. When scanning in a 3 T scanner, patients can be scanned with a whole-body averaged SAR of 2.0 W/kg (Normal Operating Mode) for all landmark location 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. IFU-9030 / C May 2021
File Type: PDF
File Size: 185 KB
File Name: ADVANCED ORTHOPAEDIC SOLUTIONS - AOS - 9030 - Magellan Femoral Nail System Instructions for Use - 2021-05 - Rev C.pdf

By clicking Download you are confirming this is the correct document for your purposes
and that you agree to our Terms & Conditions