MalfunctionJDW
SELF-DRILLING HALF PIN APEX 4MM, 120 X 30MM
Received Dec 14, 2012 · Event occurred Nov 27, 2012
Report 8031020-2012-00298 · MDR key 2924462
Device
Generic name
Implant
Manufacturer
Stryker Osteosynthesis SelzachModel number
NACatalog number
5023-3-120S
Lot number
Z08423
Product problems
- Bent
Patient
35 YR
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
DURING SURGERY FOR THE EX.FIX, THE SURGEON INSERTED THE APEX PIN. HOWEVER THE TIP OF THE APEX PIN WAS BENT ON THE THREAD PART. THEREFORE, THE SURGEON CHANGED THE APEX PIN TO ANOTHER PIN. THE PT WAS A YOUNG MAN AND BONE QUALITY WAS GOOD.
Additional Manufacturer Narrative
ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Remedial action
- Other