ADVANCED ORTHOPAEDIC SOLUTIONS

ES TROCHANTERIC NAIL, LEFT 14mm x 48cm x 130°

Galileo Trochanteric Nail System Instructions for Use

3 Pages

EN 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.  AOS GALILEO® TROCHANTERIC NAIL SYSTEM     INSTRUCTIONS FOR USE  Federal Law restricts this device to sale by or on the order of a physician DEVICE DESCRIPTION The AOS GALILEO® TROCHANTERIC NAIL SYSTEM includes the AOS GALILEO® TROCHANTERIC NAIL and the AOS ES™ TROCHANTERIC NAIL. These are open reduction and internal fixation device. The AOS TROCHANTERIC NAIL is available in 17cm, 20cm, 30cm, 33cm, 36cm, 39cm, 42cm and 45cm lengths, with proximal diameters ranging from 9mm to 14mm. All implants in the AOS GALILEO® TROCHANTERIC NAIL SYSTEM, including all nails, screws, and end caps, are made of titanium alloy. The nails have a proximal bend of 5° and two proximal screw holes. The proximal screw holes in the long nails have 10° of anteversion. One of the proximal screw holes accepts a 10.5mm Solid Lag Screw, 10.5mm Solid Locking Lag Screw, side specific 10.5mm Galileo® Lag Screw, or side specific Galileo® CRT²™ Lag Screw, which are used to lag together fractures of the proximal femur. To help minimize lag screw back out, the Solid Locking Lag Screw, Galileo® Lag Screw, and Galileo® CRT²™ Lag Screw can be locked on to the nail intraoperatively. Both the AOS Galileo® Lag Screw and Galileo® CRT²™ Lag Screw allow the threads to collapse unidirectionally up to 10mm within the barrel with the exception of the 85mm length (7mm collapse) and 90mm length (9mm collapse). The other proximal screw hole accepts an optional 5.0mm anti-rotation screw. The distal end of the nail has one slot and one hole to accept 5.0mm screws. The ES™ nails have a targeted hole in the proximal third which accepts the 5.0mm cortical screw. 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. INDICATIONS FOR USE The AOS GALILEO® TROCHANTERIC NAIL is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures. The long trochanteric nail is additionally indicated for subtrochanteric fractures, pertochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fracture, ipsilateral femoral fractures, proximal and distal non-unions and malunions and revisions procedures. The AOS ES™ TROCHANTERIC NAIL is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric, intertrochanteric and high subtrochanteric, fractures and combinations of these fractures. CONTRAINDICATIONS 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™ TROCHANTERIC NAIL. 4. Patients with a history of frequent infections. 5. Patients with known sensitivity or allergies to the implant materials. Page 1 of 3  WARNINGS The AOS GALILEO® TROCHANTERIC NAIL SYSTEM must be sterilized prior to use. Please refer to the section on STERILIZATION below. The AOS GALILEO® TROCHANTERIC NAIL 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 Galileo® Trochanteric Nail System Surgical Technique (PN 9065) for additional information on the use of the AOS GALILEO® TROCHANTERIC NAIL SYSTEM. The implants of the AOS GALILEO® TROCHANTERIC 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 GALILEO® TROCHANTERIC 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. RF HEATING Under the scan conditions defined above, AOS GALILEO® TROCHANTERIC NAIL SYSTEM implants are expected to produce a maximum temperature rise less than or equal to 5.4 ºC after 15 minutes of continuous scanning. MR ARTIFACT In non-clinical testing, the image artifact caused by AOS GALILEO® TROCHANTERIC NAIL SYSTEM implants extend radially approximately 4.1 cm from the device.  IFU-9006 / C May 2021
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