InjuryOVZ
ORTHOSORB 1 PIN 50X1.3MM KIT
Received Apr 29, 2014
Report 0001825034-2014-03339 · MDR key 3778162
Device
Generic name
Pin, Fixation, Resorbale, Hard Tissue
Manufacturer
Biomet OrthopedicsModel number
N/ACatalog number
841070
Lot number
453618
Product problems
- Break
- Detachment Of Device Component
- Component Falling
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
IT WAS REPORTED PATIENT UNDERWENT A BUNION PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE THE ORTHOSORB PIN BROKE. A PIECE OF THE PIN FELL INTO THE PATIENT'S WOUND AND WAS RETRIEVED. ANOTHER ORTHOSORB PIN WAS USED TO COMPLETE THE PROCEDURE.
Additional Manufacturer Narrative
CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION.