ADVANCED ORTHOPAEDIC SOLUTIONS
Clavicle System (Plates and Rods) Instructions for Use
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EN heating, migration, or image artifact in the MR environment. The safety of the AOS CLAVICLE PLATING SYSTEM in the MR environment is unknown. Scanning a patient who has this device may result in patient injury. For proper care and handling of AOS REUSABLE INSTRUMENTS and AOS SINGLE USE INSTRUMENTS, please refer to their package insert (IFU-9000).
AOS CLAVICLE PLATING SYSTEM
INSTRUCTIONS FOR USE
Federal Law restricts this device to sale by or on the order of a physician DEVICE DESCRIPTION The AOS CLAVICLE PLATING SYSTEM is an open reduction and internal fixation device that consist of plates and screws varying in design to provide the surgeon with multiple options to accommodate patient anatomy and optimize patient outcomes. All implants are made of titanium alloy. The plates and mating screws are designed for implantation into human subjects. The system is provided in a dedicated sterilization tray and includes an accompanying set of instruments. INDICATIONS FOR USE The AOS CLAVICLE PLATING SYSTEM provides fixation for fractures, fusions, or osteotomies for the clavicle. 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, insufficient bone quality or quantity, previous infection, or obesity. WARNINGS The AOS CLAVICLE PLATING SYSTEM must be sterilized prior to use. Please refer to the section on STERILIZATION below. The AOS CLAVICLE PLATING 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 Clavicle Plating System Surgical Technique (PN 9911) for additional information on the use of the AOS CLAVICLE PLATING SYSTEM. The implants of the AOS CLAVICLE PLATING SYSTEM are for single use only. Reuse of these devices are 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.
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 CLAVICLE PLATING 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. 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. A stable construct should be achieved and verified under image intensification. Plates may be bent at designated bending notch locations for a contoured anatomical fit. Please refer to the surgical technique (PN 9911) for proper instructions on bending plates. POSTOPERATIVE The AOS CLAVICLE PLATING SYSTEM is not designed to withstand the stress of weight bearing, load bearing, or excessive activity. Caution patients against unassisted activity that requires lifting, 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, nonunion, loosening, bending or cracking of components. The AOS CLAVICLE PLATING SYSTEM may be removed after treatment. In the absence of pain, removal of the implant in elderly or debilitated patients is not suggested.
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. The AOS CLAVICLE PLATING SYSTEM has not been evaluated for safety and compatibility in the MR environment. It has not been tested for Page 1 of 4
IFU-9047 / C May 2021
STERILIZATION The AOS CLAVICLE PLATING 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
Temperature
Exposure Time
Steam
Pre-Vacuum
270 °F (132 °C)
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 4
Advanced Orthopaedic Solutions, Inc. 3203 Kashiwa Street Torrance, CA 90505 USA Phone: 310-533-9966 Email: [email protected] IFU-9047 / C May 2021
EN The AOS CLAVICLE NAIL SYSTEM has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration, or image artifact in the MR environment. The safety of the AOS CLAVICLE NAIL SYSTEM in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.
AOS CLAVICLE NAIL SYSTEM
INSTRUCTIONS FOR USE
Federal Law restricts this device to sale by or on the order of a physician DEVICE DESCRIPTION The AOS CLAVICLE NAIL SYSTEM is an open reduction and internal fixation devices that consist of titanium alloy intramedullary rods and screws varying in design to provide the surgeon with multiple options to accommodate patient anatomy and optimize patient outcomes. The system is provided in a dedicated sterilization tray and includes an accompanying set of instruments. INDICATIONS FOR USE The AOS CLAVICLE NAIL is intended to be used to repair an acute fracture, malunion, or nonunion of the clavicle. 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, insufficient bone quality or quantity, previous infection, or obesity. WARNINGS The AOS CLAVICLE NAIL SYSTEM must be sterilized prior to use. Please refer to the section on STERILIZATION below. The AOS CLAVICLE 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 Clavicle Nail System Surgical Technique (PN 9612) for additional information on the use of the AOS CLAVICLE NAIL SYSTEM. The implants of the AOS CLAVICLE NAIL SYSTEM is for single use only. Reuse of these devices are 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.
Page 3 of 4
Refer to the packaging insert for AOS REUSABLE INSTRUMENTS and AOS SINGLE USE INSTRUMENTS (IFU-9000) for proper care and handling of these items. 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 CLAVICLE 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. 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 quantity. A stable construct should be achieved and verified under image intensification. Plates may be bent at designated bending notch locations for a contoured anatomical fit. Please refer to the surgical technique (PN 9911) for proper instructions on bending plates. POSTOPERATIVE The AOS CLAVICLE NAIL SYSTEM is not designed to withstand the stress of weight bearing, load bearing, or excessive activity. Caution patients against unassisted activity that requires lifting, 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, nonunion, loosening, bending or cracking of components. The AOS CLAVICLE NAIL SYSTEM may be removed after treatment. In the absence of pain, removal of the implant in elderly or debilitated patients is not suggested.
IFU 9047 / C May 2021
STERILIZATION The AOS CLAVICLE 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
Temperature
Exposure Time
Steam
Pre-Vacuum
270 °F (132 °C)
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 4 of 4
Advanced Orthopaedic Solutions, Inc. 3203 Kashiwa Street Torrance, CA 90505 USA Phone: 310-533-9966 Email: [email protected] IFU-9047 / C May 2021