Proximal Humeral Plating System Instructions for Use

2 Pages

EN AOS PROXIMAL HUMERAL PLATING SYSTEM    INSTRUCTIONS FOR USE Federal Law restricts this device to sale by or on the order of a physician DEVICE DESCRIPTION The AOS PROXIMAL HUMERAL PLATING SYSTEM is an open reduction and internal fixation devices that consist of titanium alloy plates and screws varying in design to provide the surgeon with multiple options to accommodate patient anatomy and optimize patient outcomes... he system is provided in a dedicated sterilization tray and includes an accompanying set of instruments... NDICATIONS FOR USE The AOS PROXIMAL HUMERAL PLATING SYSTEM is indicated for fractures, fracture dislocations, osteotomies, and nonunion of the proximal humerus... 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, insufficient bone quality or quantity, previous infection, or obesity... ARNINGS The AOS PROXIMAL HUMERAL PLATING SYSTEM must be sterilized prior to use... lease refer to the section on STERILIZATION below... he AOS PROXIMAL HUMERAL PLATING 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 Proximal Humeral Plating System Surgical Technique (PN 9023) for additional information on the use of the AOS PROXIMAL HUMERAL PLATING SYSTEM... he implants of the AOS PROXIMAL HUMERAL PLATING 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... The AOS PROXIMAL HUMERAL PLATE has not been evaluated for safety and compatibility in the MR environment... t has not been tested for heating, migration, or image artifact in the MR environment... he safety of the AOS PROXIMAL HUMERAL PLATING SYSTEM in the MR environment is unknown... canning a patient who has this device may result in patient injury... or proper care and handling of AOS REUSABLE INSTRUMENTS and AOS SINGLE USE INSTRUMENTS, please refer to their package insert (IFU-9000)... 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 PROXIMAL HUMERAL PLATING 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... lates may be bent at designated bending notch locations for a contoured anatomical fit... lease refer to the AOS Proximal Humeral Plating System Surgical Technique (PN 9023) for proper instructions on bending plates... OSTOPERATIVE The AOS PROXIMAL HUMERAL PLATE is not designed to withstand the stress of weight-bearing, load-bearing, or excessive activity... aution patients against unassisted activity that requires lifting, 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 PROXIMAL HUMERAL PLATE may be removed after treatment... n the absence of pain, removal of the implant in elderly or debilitated patients is not suggested... Page 1 of 2  IFU-9021 / U May 2021   STERILIZATION The AOS PROXIMAL HUMERAL PLATING 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-9021 / U May 2021
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