STERNUM BLADE
Received Jan 16, 2012 · Event occurred Dec 20, 2011
Report 9616696-2012-00016 · MDR key 2435236
Device
Product problems
- Break
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BLADE BROKE AND CUT INTO THE BLADE GUARD. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INJURY AND THERE WAS NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE BROKEN PIECE DID NOT FALL INTO THE SURGICAL SITE. IT WAS ALSO REPORTED THAT ANOTHER BLADE WAS AVAILABLE TO COMPLETE THE PROCEDURE.
Additional Manufacturer Narrative
THE BLADE SUBJECT TO THIS MDR WAS RETURNED FOR EVALUATION. IT WAS VISUALLY CONFIRMED THAT THE BLADE BROKE ALONG THE SHAFT. THE RETURNED BLADE WAS MEASURED WHERE POSSIBLE AND ALL CRITICAL SPECIFICATIONS WERE MET. LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED TO PERMIT FURTHER INVESTIGATION. THE ROOT CAUSE IS UNDETERMINED. THE HANDPIECE ASSOCIATED WITH THIS MDR IS AS FOLLOWS; PART NUMBER: 6207000000, SERIAL NUMBER: (B)(4).