Twist-off screw
Product description
Twist-off screws are manufactured at the facilities of SARL CHOC, rue Louis Lépine, Albasud 3, 82000 Montauban, France.
They are manufactured from ISO 5832-3 standard TA6V ELI titanium. All materials are obtained from ISO 9001 certified suppliers, who provide for each titanium delivery a material conformity certificate with a physicochemical analysis.
The screws are produced in accordance with our manufacturing procedures: a manufacturing order is issued by the Production Manager. For each manufacturing order, the Production Manager assigns a four digit batch number. The manufacturing order details all the operations to be carried out on the products. At each stage, various dimensional verifications are carried out by the manufacturing operators and by the Production Manager. All inspection forms are kept with the manufacturing order.
Twist-off screws are self-drilling, self-tapping and self twist-off; the screws twisting off after they are tightened.
Dimensional characteristics
Twist-off screws are 2mm in diameter and are available in the following lengths: 5mm / 7mm / 9mm / 11mm / 12mm / 13mm / 14mm / 15mm / 17mm / 19mm / 21mm / 24mm.
Micro-twist-off screws are 1.3mm in diameter and are available in lengths of 10 / 12 / 14 / 16mm.
Micro-twist-off screw are 1.6mm in diameter are available in lengths of 8 / 9 / 10 / 12 / 14mm.
M.I.S.S. screws are available in lengths of 13 - 15 - 17 & 19mm.
 TWIST-OFF SCREWS; FOR HAND AND FOOT OSTEOSYNTHESIS
REF: 14.52.XX
Fifteen sizes of screws are available: XX representing lengths from 5mm to 24mm.
Self-drilling, self-tapping compression twist-off screw with a new type of drill bit allowing it to be used over its whole lenght.
SURGICAL TECHNIQUE
Determine the required length of screw (from external cortex to external cortex) using the measuring tool (14.33.05).
-On opening the peel-off blister, put to one side the traceability stickers (1 for order renewal, 4 for the patient file), - Set the motor unit speed to about 500rpm.
- Place the screw on the external cortex, and switch on the motor whilst applying pressure for the drilling of the cortex.
- Once the thread takes, the screw will move forward without pressure, and on compression, it will twist-off the screw rod.
- Once screwed in, the head of the screw is flush with the external cortex.
The bone weakening safety may cause premature separation of the screw from its rod: Continue to screw using the manual screwdriver (14.31.02) or the electric screwdriver (14.33.02) mounted on a hand piece or the Jacobs chuck on a very slow speed.
To ensure traceability, the screws are individually packaged individually in double blister packs, the first containing the screw and a sterilisation indicator label; the second blister contains the first blister and five traceability stickers with the screw reference, description and batch number.
The packed screws are then sent to Synergy Health France (MIN des Arnavaux- 13014 MARSEILLE) for sterilisation by gamma radiation according to the ISO 11137-02, ISO 11737-1, ISO 11737-2, EN 552, EN 556 standards and dose mapping. After sterilisation, SYNERGY HEALTH returns the batch of sterilised screws with a certificate of sterilisation by gamma radiation.
The screws in the packaging are then labelled. The label includes the description, the reference, the production batch number, the method of sterilisation, the expiry date, the "single use" and "read instructions before use" symbols, the manufacturer's name and address and the CE 1014 markings.
The screws are packed in boxes identically labelled as above, stretch-wrapped and stored in closed cupboards, away from direct light. Storage conditions: no special conditions.