SELF-DRILLING HALF PIN APEX 5MM, 180 X 50MM
Received Oct 6, 2011 · Event occurred Sep 13, 2011
Report 8031020-2011-00213 · MDR key 2314705
Device
Generic name
Implant
Manufacturer
Stryker Osteosynthesis SelzachModel number
NACatalog number
5016-5-122S
Lot number
W31038
Product problems
- Break
- Sticking
Patient
UNK
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem
DURING THE OPERATION FOR THE FRACTURE OF FEMUR, WHILE THE SURGEON INSERTED THE APEX PIN WITH POWER TOOL, THE APEX PIN COULD NOT BE MOVED AT THE TIP OF THE APEX PIN ENTERED INTO THE OPPOSITE CORTICAL BONE ABOUT 6-7 MM. THE SURGEON REPLACED POWER TOOL TO BRACE AND TRIED TO INSERT OR BACKWARD THE APEX PIN BY HAND BUT IT FAILED. THEN THE SURGEON TRIED TO ADVANCE THE APEX PINS SLOWLY WITH THE BRACE, THE TOP OF THE APEX PIN BROKE AND REMAINED IN THE BONE. THE PATIENT WAS YOUNG MAN AND BONE QUALITY WAS GOOD.
Remedial action
- Other