MalfunctionJDW
SELF-DRILLING HALF PIN APEX 5MM, 200 X 60MM
Received Aug 8, 2012 · Event occurred Jul 25, 2012
Report 8031020-2012-00191 · MDR key 2702436
Device
Generic name
Implant
Manufacturer
Stryker Osteosynthesis SelzachModel number
NACatalog number
5018-6-200
Lot number
X20852
Product problems
- Break
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
DOCTOR HEAD OF THE ORTHO AND TRAUMA DEPARTMENT REPORTED TO OUR SALES REP THAT HE WAS PERFORMING SURGERY PROCEDURE. WHILE INSERTION OF THE DRILL ASSEMBLY, THE APEX PIN BROKE AT THE TIP OF THE DISTAL TIBIA. THE SURGEON REMOVED THE TIP. A REPLACEMENT WAS AVAILABLE TO COMPLETE THE SURGERY.
Additional Manufacturer Narrative
ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Remedial action
- Other