MalfunctionJDW
SELF-DRILLING HALF PIN APEX 5MM, 180 X 50 MM
Received Nov 21, 2012 · Event occurred Nov 9, 2012
Report 8031020-2012-00288 · MDR key 2885287
Device
Generic name
Implant
Manufacturer
Stryker Osteosynethesis SelzachModel number
NACatalog number
5018-6-180
Lot number
Z04433
Product problems
- Break
Patient
UNK
- Device Embedded In Tissue or Plaque
Narrative
Description of Event or Problem
TIP OF PIN HAS BROKEN OFF OF APEX PIN DURING PROCEDURE, TIP REMAINS IN PATIENT APPARENTLY. AWAITING SURGEON DETAILS TO CONFIRM EXACT MODE OF USE AND OUTCOMES.
Additional Manufacturer Narrative
ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Remedial action
- Other