MalfunctionJDW
LOCKING SCREW AXSOS 4.0MM/L28MM
Received Mar 27, 2012 · Event occurred Mar 8, 2012
Report 8031020-2012-00095 · MDR key 2530715
Device
Generic name
Implant
Manufacturer
Stryker Osteosynthesis SelzachModel number
NACatalog number
371528
Lot number
UNK
Product problems
- Break
- Detachment Of Device Component
Patient
96 YR
- No Information
Narrative
Description of Event or Problem
IT WAS REPORTED, "THE DOCTOR WAS INSERTING A 4.0MM X 28MM AXSOS LOCKING SCREW INTO A PROXIMAL HUMERAL PLATE LOCKING HOLE USING THE POWER SCREWDRIVER WITHOUT A TORQUE LIMITER. WHEN THE SCREW REACHED ITS FINAL POSITION IN THE PLATE, THE HEAD OF THE SCREW BROKE OFF. THE DOCTOR THEN DECIDED TO LEAVE THE REST OF THE SCREW IN."
Additional Manufacturer Narrative
ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Remedial action
- Other