General Precautions - Orthofix G-Beam Fusion Beaming System Gebrauchsanweisung

GENERAL PRECAUTIONS

1. Ensure that all components needed for the operation are available in the operating theatre.
2. Examine all components carefully prior to use. Product integrity, sterility (in the case of sterile products) and performance are assured only if the packaging is undamaged.
3. Careful handling and storage of the product is required. Scratching or damage to the component can significantly reduce the strength and fatigue resistance of the products.
4. Prior to surgical use, user must ensure all instruments function as intended.
5. Cannulated instruments should be inspected prior to use to confirm that the cannulation is free from obstruction. The correctly sized guidewire should be passed through it to check that it slides easily.
6. Ensure that drilling and cutting tools are sharp.
7. Select the appropriate color-coded instruments for the selected implant to be used.
8. Screen with an image intensifier during guidewire insertion, drilling and G-Beam™ insertion, removal and whenever necessary. In all cases, the benefit of fluoroscopy should be weighed against the risk
from radiation exposure on an individual patient basis.
9. If preoperatively the patient is able to actively plantarflex the great toe metatarsal phalangeal joint, the plantar approach is not recommended as this may damage the plantar plate, one or both flexor tendons
and possibly the sesamoids.
10. Always assemble the 7.4mm diameter G-Beam™ with the chosen end cap before insertion.
11. Ensure not to place the guidewire groove within a joint line.
12. Avoid penetrating the posterior cortex/subchondral bone of the talus during guidewire insertion and drilling in order to obtain good bone purchase.
13. Ensure that the leading threads have purchase of the bone of the talar body or neck/body junction and that the trailing threads have purchase of subchondral bone of the metatarsal head.
POSSIBLE ADVERSE EFFECTS
1. Loosening of the implant and loss of fixation.
2. Bending, breakage or other damage to the implant.
3. Implant migration/dislocation.
4. Delayed union, malunion or nonunion.
5. Increased fibrous tissue response.
6. Bone and soft tissue infection.
7. Neurovascular, soft tissue and bone damage.
8. Post-operative pain.
9. Metal sensitivity reactions.
10. Sensitive scar/soft tissue irritation.
11. Shortening of the affected bone.
12. Joint stiffness and contracture.
13. Thromboembolic events.
14. Avascular necrosis.
15. Wound healing complications.
16. Insufficiency fractures in surrounding bones.
A successful result is not achieved in every surgical case. Additional complications may develop at any time due to improper use, medical reasons or device failure that require surgical re-intervention to remove
or replace the internal fixation device. Preoperative and operative procedures including knowledge of surgical techniques and proper selection and placement of the device are important considerations in the
successful utilization of the devices by the surgeon.
MRI SAFETY INFORMATION
The Orthofix G-Beam™ 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
Orthofix G-Beam™ in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.
RISKS DUE TO THE RE-USE OF "SINGLE USE" DEVICE
Implantable Device*
The "SINGLE USE" implantable device* of Orthofix is identified through symbol " " reported on the product label. After the removal from the patient, the implantable device* has to be discarded.
The re-use of implantable device* introduces contamination risks for users and patients.
The re-use of implantable device* can not guarantee the original mechanical and functional performances, compromising the effectiveness of the products and introducing health risks for the patients.
(*): Implantable device
Any device intended to be totally/partially introduced into the human body through surgical intervention and intended to remain in place after the procedure for at least 30 days is considered an implantable device.
Non Implantable Device
The "SINGLE USE" non implantable device of Orthofix is identified through symbol " " reported on the label or indicated in the "Instructions For Use" supplied with the products. The re-use of "SINGLE USE"
non implantable device cannot guarantee the original mechanical and functional performances, compromising the effectiveness of the products and introducing health risks for the patients.
INSTRUCTIONS FOR PROCESSING AND REPROCESSING
These instructions apply to G-Beam™.
These reprocessing instructions are written in accordance with ISO17664 and have been validated by Orthofix in compliance with international standards. It is the responsibility of the health care facility to ensure that the reprocessing
is performed in accordance with Orthofix reprocessing validated instructions and to perform verification and routine monitoring of the process accordingly. Any deviation from these instructions is responsibility of the health care
facility in charge of reprocessing.
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