UMED-FIX ®
Product description
UMED-FIX®
UMED-FIX® has been designed to be used both as an external fixator for metacarpal and phalanx osteosynthesis, and as a distractor in the treatment of joint fractures or stiffness.
UMED-FIX® is a unique blocking system. It is rigid, sturdy, light and compact.
It comes sterilised in double blister packs with five traceability stickers.
Dimensional characteristics
UMED-FIX® is a kit comprised of a fixator module (4 terminals), six 1.2 mm diameter threaded pins and 12 protective pin ends.
14.63.21 UMED-FIX 1.2 mm pin
14.63.22 UMED-FIX protective pin end
14.33.64 UMED-FIX external fixator mounts
Joint distraction with UMED-FIX
The bone anchor pins are threaded to ensure better stability.
The corrective modules are miniaturised and radiolucent.
The axial rod is threaded to allow progression of the distraction thumb wheel.
Protective pin ends isolate the extremities of the anchor pins.
UMED-FIX osteosynthesis
Insertion of the first proximal pin
The first pin is inserted after the fracture reduction with the aid of an image intensifier.
The two modules and the axial rod are mounted on the first pin and serve as a guide for the insertion of the other pins.
Insertion of the first distal pin
The pin is inserted in the distal module after checking the correct alignment of the assembly with the image intensifier.
Insertion of the second proximal pin
The correctly aligned modules serve as a guide for the insertion of the other pins.
Insertion of the second distal pin
Tightening of the screws
The screws are tightened after having checked fracture reduction using the image intensifier and whilst maintaining compression of the fracture zone.
Fitting of the protective pin ends
It is advised to keep a gap of 2 to 3mm between the skin and the device before fitting the protective pin ends.
Complement and reduction
Any minimal residual angulation can be corrected by twisting the axial rod.
To ensure UMED-FIX traceability, it comes individually packed in a double blister pack with the fixator module, 12 pin ends, 6 pins and a sterilisation indicator label. The second blister contains the first blister and five traceability stickers with the product reference, description and batch number.
The UMED-FIX is 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 products 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 UMED-FIX is packed in boxes identically labelled as above, stretch-wrapped and stored in closed cupboards, away from direct light and humidity.
Storage conditions: no special conditions.