ORTHOSORB 1 PIN 50X1.3MM KIT
Received Jan 14, 2014 · Event occurred Dec 13, 2013
Report 0001825034-2014-00433 · MDR key 3573284
Device
Generic name
Pin, Fixation
Manufacturer
Biomet OrthopedicsModel number
N/ACatalog number
841070
Lot number
389436
Product problems
- Fracture
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A BUNIONECTOMY ON (B)(6) 2013. DURING THE PROCEDURE, THE ORTHOSORB PIN FRACTURED. ANOTHER PIN WAS UTILIZED TO COMPLETE THE PROCEDURE.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.
Additional Manufacturer Narrative
MANUFACTURING HISTORY NECESSARY WAS NOT PROVIDED FOR REVIEW. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - UNKNOWN. EXPIRATION DATE - UNKNOWN. MANUFACTURE DATE ¿ UNKNOWN. 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 THERE WERE SPIRAL ABRASIONS, SCRATCHES & GOUGES LEADING UP TO THE FRACTURE. THE SPIRAL PATTERN SUGGESTS THE SHAFT CONTACTED A HARD METAL OBJECT DURING ROTATION.