MISS II screw
Product description
The M.I.S.S. II screws are manufactured at the facilities of SARL CHOC, rue Louis Lépine, Albasud 3, 82000 Montauban, France.
The M.I.S.S. II screws 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.
The M.I.S.S. II screws are self-drilling and self tapping.
Dimensional characteristics
The M.I.S.S. II screws head diameter is 2.6mm and that of the body 2mm, and they are available in the following lengths: 13 - 15 - 17 - 19 and 22 mm.
M.I.S.S. II SCREW (Minimally Invasive System Screw):
38.94.13 (13mm) - 38.94.15 (15mm) - 38.94.17 (17mm) - 38.94.19 (19mm) - 38.94.22 (22mm)
The ISO 5832-3 titanium self-drilling, self-tapping, conical compression screw has a new thread system allowing integral use of the screw.
Only qualified and experienced staff may use and fit MISS II screws.
SURGICAL TECHNIQUE
- On opening the peel-off blister, put to one side the traceability stickers (1 for order renewal, 4 for the patient file).
- Apply the minimally invasive surgical technique for correcting Hallux-Valgus (lateral arthrolysis incision with bone cleansing and placing of right hand or left hand cutting guide and metatarsal osteotomy with displacement of the bone).
- Pre-drill the cortical bone using a square awl (14.33.25).
- Mount the stopper guide on the le MISS II screw (14.33.28) shaft and mount the assembly on the motor. Mount the MISS II screw on to the blade.
- Position the screw on the pre-drilled external cortical with the square awl and switch on the motor whilst applying pressure.
- Once the thread takes, the screw will move forward without pressure.
- The stopper allows removal of the blade once the screw head has sunken about 1mm into the bone
Contraindications: Allergies to implant materials Infection or latent infection in the area due to be operated on.
MISS screwdriver + square awl
14.33.25: square awl for MISS screw
To ensure screw traceability, they are individually packed in double blisters; the first containing the screw, the 2 cutting guides (right and left), stopper (to be mounted onto the screwdriver) 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 ISOTRON 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, ISOTRON 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.