Adverse Effects - INION HEXALON VIS LCA/LCP BIODEGRADABLE Mode D'emploi

Insert the screw into the desired position over the guide wire to the appropriate depth then withdraw the screwdriver and guide
wire. Please note that the screw must always be implanted completely inside the bone (i.e., below or flush with the bone
surface) to avoid soft tissue irritation by protruding screw.
It is important to hold the screwdriver and the screw parallel to the long axis of the bone tunnel during screw insertion.
Surgeons must apply their professional judgment when determining the appropriate screw size based on the specific
indication, preferred surgical technique and patient history.
When using soft tissue grafts in the knee, depending on the bone quality, the screw diameter should be 0-1 mm larger than
the diameter of the graft/bone tunnel.
When fixing tendons/ligaments/grafts into non-transosseous bone sockets (outside the knee indication), the bone socket
should be 1 mm larger than the diameter of the screw/graft and at least 2 mm longer than the screw.
Note: Take care to ensure that the tip of the screwdriver is inserted all the way down to the bottom of the screw
socket before screw insertion.
6. If there is difficulty to insert the screw (e.g., due to high bone density), repeat step 4, and try again.
If the tip of the screwdriver gets stuck in the screw socket during screw insertion, remove the screwdriver by gently tapping on
the front end of the handle of the screwdriver with a small mallet (i.e., in outward direction).
If the screw can be inserted almost without any torsional resistance consider removing the screw and replacing it with one size
larger diameter screw for optimal fixation strength.
• In case of ACL/PCL reconstruction, complete femoral fixation first (as described above), and thereafter repeat steps 3-5 for tibial fixation.
• For more detailed surgical instructions, please refer to appropriate surgical technique literature.
Post operative reminders
• As with any surgical procedure, careful postoperative management is important for optimal healing.
• Provide the patient with detailed instructions for postoperative care (e.g. regarding immobilization).
• Antibiotic therapy at the discretion of the clinician.
Evaluation of results
Radiographs can be taken to evaluate bone healing.
The device is MR Safe.
WARNINGS
• Incorrect selection, insertion, placement, positioning, fixation, torque overload or bending of the implant can cause subsequent undesirable
results or breakage of the screw or instrument. The surgeon should be familiar with the devices, the method of application and the surgical
procedure prior to performing the surgery.
• Thin soft tissue coverage over the implant may increase the risk of complications.
PRECAUTIONS
• Instruments are available to aid accurate implantation of the INION HEXALON™ BIODEGRADABLE ACL/PCL SCREW. Surgical instruments
are subject to wear with normal usage and may break. Surgical instruments are only to be used for their intended purpose. All instruments are to
be regularly inspected for wear and damage. Use only the INION HEXALON™ instruments for screw insertion.
• DO NOT use for unintended applications! Proper function (i.e. effectivity and safety) of these implants cannot be guaranteed in case of off-label
use.
• The patient should be warned that the fixation given with this device can break or loosen as a result of early stress, activity or load bearing.

ADVERSE EFFECTS

Complications are similar to those with any method of internal fixation:
• Infection can lead to failure of the fixation.
• Neurovascular injuries can occur due to surgical trauma.
• Complications encountered with any ACL/PCL internal fixation include restricted extension or flexion, fixation failure, arthrofibrosis etc.
• Implantation of foreign materials can result in an inflammatory response or allergic reaction. Transient local fluid accumulation may occur in
sterile circumstances.
STERILITY
The INION HEXALON™ BIODEGRADABLE ACL/PCL SCREW has been sterilized with ionizing irradiation. Use immediately after opening the
sterile seal. Use only devices that are contained in unopened and undamaged packages. For single use only. DO NOT re-sterilize or re-use! If
the device is re-sterilized or re-used, the properties of the implant will be affected, and the safety and efficacy cannot be guaranteed. Do not use
implant beyond the expiration date on the label.
STORAGE
Store at room temperature (15 to 30°C / 59 to 86°F) at a normal relative humidity. Product should not exceed a maximum temperature defined
on the indicator. Do not use if the indicator dot is black.
CAUTION
Federal law (USA) restricts this device to sale by or on the order of a licensed physician.
MANUFACTURER
INION Oy
Lääkärinkatu 2
33520 Tampere