MalfunctionJDW
SELF-DRILLING HALF PIN APEX 3MM, 80 X 20MM
Received Jan 10, 2012 · Event occurred Dec 20, 2011
Report 8031020-2012-00006 · MDR key 2417498
Device
Generic name
Implant
Manufacturer
Stryker Osteosynthesis SelzachModel number
NACatalog number
5038-5080
Lot number
UNK
Product problems
- Break
- Detachment Of Device Component
- Sticking
Patient
56 YR
- No Information
Narrative
Additional Manufacturer Narrative
ADD'L INFO HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem
IT WAS REPORTED THAT, DURING THE IMPLANTATION OF THE 3MM APEX PIN INTO THE RADIUS THE BITE WAS SO STRONG THAT THE HEAD OF THE PIN BROKE OFF INSIDE OF THE 5MM WRENCH AND IS NOW STUCK.
Remedial action
- Other