INION HEXALON VIS LCA/LCP BIODEGRADABLE Mode D'emploi

12000083 (13/2019-04-01)
ENGLISH
INION HEXALON™ BIODEGRADABLE ACL/PCL SCREW
INSTRUCTIONS FOR USE
DESCRIPTION
The INION HEXALON™ BIODEGRADABLE ACL/PCL SCREW is an interference screw intended to allow secure fixation and maintain the
stability of bone-tendon-bone or soft tissue grafts in conjunction with appropriate immobilization.
The INION HEXALON™ BIODEGRADABLE ACL/PCL SCREW is made of degradable co-polymers composed of L-lactic acid, D-lactic acid and
trimethylene carbonate. These polymers have a long history of safe medical use and they degrade in vivo by hydrolysis into alpha-hydroxy acids
that are metabolised by the body. The coloured screws are dyed green for better visualization during the surgical procedure by a minimal amount
of Drug and Cosmetic (D&C) Green No. 6, which is used in several biodegradable sutures. The INION HEXALON™ BIODEGRADABLE
ACL/PCL SCREW gradually loses strength during 18-36 weeks. Bioresorption takes place within two to four years.
The INION HEXALON™ BIODEGRADABLE ACL/PCL SCREW is offered in different sizes and is cannulated allowing the screw to be inserted
over a guide wire. The screw is designed to be used with customized instrumentation, e.g. the INION HEXALON™ GUIDE WIRES,
RAPIDNOTCHER, and SCREWDRIVER.
The INION HEXALON™ BIODEGRADABLE ACL/PCL SCREW is sterile and non-collagenous.
INDICATIONS
Indications (CE mark):
The INION HEXALON™ BIODEGRADABLE ACL/PCL SCREW is intended for interference fixation in anterior and posterior cruciate ligament
reconstruction using bone-tendon-bone or soft tissue grafts.
Indications (USA):
The INION HEXALON™ BIODEGRADABLE ACL/PCL SCREW is intended for soft tissue (including ligament, tendon, and bone-tendon-bone
graft) fixation to bone in surgeries of the knee, shoulder, elbow, ankle, foot, hand and wrist where the offered screw sizes are patient appropriate.
CONTRAINDICATIONS
The INION HEXALON™ BIODEGRADABLE ACL/PCL SCREW is contraindicated in case of:
• Insufficient quality or quantity of bone for interference screw attachment.
• Active or potential infections.
• Patient conditions including limited blood supply, chronic disease which causes insufficient quality of bone, and where patient co-operation
cannot be guaranteed (e.g. alcoholism, drug abuse).
INFORMATION FOR USE
Surgical instructions
• Maintain sterile field throughout the procedure.
• For easy and safe screw insertion:
1. Drill the bone tunnel(s) to anatomic attachment site(s).
2. Place the graft into position in the tunnel(s). Take care to ensure that the graft is placed deep enough into the tunnel(s)
before screw insertion, especially when fixing tendons/ligaments/grafts into non-transosseous bone sockets! Tighten the graft
(as appropriate considering the specific indication) before completion of graft fixation.
3. Position the INION HEXALON™ GUIDE WIRE between the graft and the bone tunnel wall where the screw is desired.
Alternatively the guide wire can be inserted into the bone tunnel simultaneously with the graft when the graft is placed into
position.
Note: In either case ensure that the guide wire is parallel with the long axis of the bone tunnel!
4. To facilitate screw insertion, the tunnel entrance can be prepared using INION HEXALON™ RAPIDNOTCHER:
Note: Always use the INION HEXALON™ RAPIDNOTCHER before screw insertion in the knee, in case of dense bone,
and with screw sizes larger than 7 mm!
5. Take an appropriately sized INION HEXALON™ BIODEGRADABLE ACL/PCL SCREW, push the tip of the INION
HEXALON™ SCREWDRIVER into the bottom of the screw socket, ensuring that the screwdriver is completely engaged for
the full length of the screw.
• INION HEXALON™ RAPIDNOTCHER: Insert the cannulated instrument over the guide wire between the
graft and the bone tunnel wall until the cutting blade of the instrument comes to contact with the bone
surface at the desired screw position. Please note that the notcher has a cutting blade only on one side of
the instrument. Always position the cutting blade of the instrument away from the graft and towards the
bone tunnel wall to avoid damaging the graft with the cutting blade. Create a notch at the tunnel entrance by
tapping the instrument gently with a mallet to cut the bone at the tunnel entrance to facilitate screw
insertion. Once the cutting blade is partially inside the bone, the instrument may additionally be rotated back
and forth in an arc of 180 degrees to further cut the bone and to round any sharp edges at the tunnel
entrance. After notching, withdraw the notcher, keeping the guide wire in place.