ORTHOSORB 1PN/3PK 40X1.3MM KIT
Received Nov 7, 2014 · Event occurred Oct 10, 2014
Report 0001825034-2014-08561 · MDR key 4237874
Device
Generic name
Pin, Fixation
Manufacturer
Biomet OrthopedicsModel number
N/ACatalog number
841052
Lot number
482983
Product problems
- Split
Patient
46 YR
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. A REVIEW OF DEVICE HISTORY RECORDS HAS BEEN REQUESTED. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.
Additional Manufacturer Narrative
EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. DURING THE EVALUATION, IT WAS NOTED THE ROOT CAUSE OF THE EVENT WAS MOST LIKELY DUE TO MISUSE OR MISALIGNMENT OF THE RESORBABLE PIN CAUSING THE PIN TO SPLIT DURING INSERTION, AND/OR THE DEVICE WAS NOT INSPECTED FOR WEAR AND DISFIGUREMENT PRIOR TO USE, WHICH MAY HAVE PREVENTED THE USE OF THE INSTRUMENT AND ITS FAILURE.
Description of Event or Problem
IT WAS REPORTED THAT DURING A BUNIONECTOMY ON (B)(6), 2014, THE SURGEON HAD THE PIN PREPARED AND WAS PLUNGING THE PIN INTO THE PATIENT WHEN THE PIN SPLIT VERTICALLY. ANOTHER ORTHOSORB PIN WAS USED SUCCESSFULLY AND PATIENT DID NOT RETAIN ANY FOREIGN BODIES.