PPDA® screw
Product description
The Self-drilling PPDA® Screw is a Perforated Auto Compression Variable Pitch screw
The PPDA® screws come in sterile double blister packs with 5 traceability stickers.
Each PPDA screw comes with a 70mm - 10/10 trocar point pin.
Dimensional characteristics
PPDA screws have a head diameter of 4mm and a body diameter of 3mm, and are available in the following lengths: 10mm / 12mm / 14mm / 16mm / 18mm / 20mm / 22mm / 24mm / 26mm / 28mm / 30mm / 32mm / 34mm.
P.P.D.A. screw AUTOFOREUSE® (self-drilling)
PPDA screws are used to fix M1 scarf osteotomies. The screw is screwed in directly with the motor and without the prior use of a drill bit which is always difficult to clean.
SURGICAL TECHNIQUE
- After making the two scarf cut marks (longitudinal and transversal) and maintaining the two fragments using forceps or crab tongs, place the two guide pins. The scarf screws will be placed over these pins.
- On opening the peel-off blister, put to one side the traceability stickers (1 for order renewal, 4 for the patient file).
- Slide the screw over the pin, the screw length having previously been determined, and screw in the screw using the motor set at about 100rpm.
- If the motor stops, continue to screw it in using the manual screwdriver.
To ensure traceability, the screws are individually packaged in double blister packs, the first containing the screw and a sterilisation indicator label; the second blister contains the first blister and five stickers with the screw reference, description and batch number.
The packed screws are then sent to SYNERGY HEALTH 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, expiry date, the "single use" and "read instructions before use" symbols, the manufacturer's name and the CE 1014 markings.
The screws are packed with a 7cm 10/10 pin manufactured from ISO 5832-1 standard 316L stainless steel sterilised in the same conditions in boxes identically labelled as previously, and stored in closed cupboards away from direct sun.