ES TROCHANTERIC NAIL, RIGHT 10mm x 30cm x 130°

Galileo Trochanteric Nail System Instructions for Use

3 Pages

EN 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... hese are open reduction and internal fixation device... he AOS TROCHANTERIC NAIL is available in 17cm, 20cm, 30cm, 33cm, 36cm, 39cm, 42cm and 45cm lengths, with proximal diameters ranging from 9mm to 14mm... ll implants in the AOS GALILEO® TROCHANTERIC NAIL SYSTEM, including all nails, screws, and end caps, are made of titanium alloy... he nails have a proximal bend of 5° and two proximal screw holes... he proximal screw holes in the long nails have 10° of anteversion... ne of the proximal screw holes accepts a 10... m Solid Lag Screw, 10... m Solid Locking Lag Screw, side specific 10... m Galileo® Lag Screw, or side specific Galileo® CRT²™ Lag Screw, which are used to lag together fractures of the proximal femur... o 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... oth 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)... he other proximal screw hole accepts an optional 5... m anti-rotation screw... he distal end of the nail has one slot and one hole to accept 5... m screws... he ES™ nails have a targeted hole in the proximal third which accepts the 5... m cortical screw... he proximal end of the nail is threaded to accept an end cap... he system is provided in a dedicated sterilization tray and includes an accompanying set of instruments... NDICATIONS 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... he 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... he 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... ONTRAINDICATIONS 1... atients with an active superficial infection... ediatric patients, or patients with skeletal immaturity... atients with shaft fractures should not be treated with the AOS ES™ TROCHANTERIC NAIL... atients with a history of frequent infections... atients with known sensitivity or allergies to the implant materials... age 1 of 3  6... 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 GALILEO® TROCHANTERIC NAIL SYSTEM must be sterilized prior to use... lease refer to the section on STERILIZATION below... he AOS GALILEO® TROCHANTERIC NAIL 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 Galileo® Trochanteric Nail System Surgical Technique (PN 9065) for additional information on the use of the AOS GALILEO® TROCHANTERIC NAIL SYSTEM... he implants of the AOS GALILEO® TROCHANTERIC 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 GALILEO® TROCHANTERIC 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 can be scanned with a whole-body averaged SAR of 2... W/kg (Normal Operating Mode) when landmarked superior to the hip for a maximum scan time of 15 minutes... f scanning is performed between below the hip, the wholebody SAR needs to be limited to 1... W/kg or less for a maximum scan time of 15 minutes... hen scanning in a 3 T scanner, patients can be scanned with a whole-body averaged SAR of 2... W/kg (Normal Operating Mode) for all landmark location 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 GALILEO® TROCHANTERIC 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 GALILEO® TROCHANTERIC NAIL SYSTEM implants extend radially approximately 4... cm from the device... FU-9006 / C May 2021   POSSIBLE 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 GALILEO® TROCHANTERIC 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... llergies 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... he Trochanteric End Cap with Post implant should not be used with the AOS Solid Locking Lag Screw or Galileo® Telescoping Lag Screw, as it may cause damage to the locking feature of the screws... he lockout spacer in the Galileo® Telescoping Lag Screw should always be removed after implantation of the screw... he telescoping feature only works properly if the lockout spacer is removed... OSTOPERATIVE The AOS GALILEO® TROCHANTERIC 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, nonunion, loosening, bending, or cracking of components... ssure daily cleansing of pin-skin interface... aintain meticulous daily pin site care management to prevent infection... he AOS GALILEO® TROCHANTERIC NAIL SYSTEM may be removed after treatment... n the absence of pain, removal of the implant in elderly or debilitated patients is not suggested... TERILIZATION The AOS GALILEO® TROCHANTERIC 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... Page 2 of 3  IFU-9006 / C May 2021
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