UNK STERNUM BLADE
Received Jun 28, 2012 · Event occurred Jun 3, 2012
Report 9616696-2012-00181 · MDR key 2646041
Device
Product problems
- Bent
- Break
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A STERNOTOMY PROCEDURE, THE STERNUM BLADE GUARD BENT DURING SAWING AND A PIECE OF BLADE BROKE. IT WAS ALSO REPORTED THAT SURGERY WAS DELAYED BY 30 MINS AND THE BROKEN PIECE WAS REMOVED FROM THE SURGICAL SITE. IT WAS FURTHER REPORTED THAT A REPLACEMENT WAS AVAILABLE AND THE SURGERY WAS SUCCESSFULLY COMPLETED.
Additional Manufacturer Narrative
THE BLADE SUBJECT TO THIS INVESTIGATION WAS NOT RETURNED TO THE MFR FOR EVAL. PART NUMBER AND LOT NUMBER INFO HAS NOT BEEN PROVIDED TO PERMIT FURTHER INVESTIGATION. THE BLADE GUARD WAS RETURNED FOR INVESTIGATION, VISUAL INSPECTION CONFIRMED THAT THE BLADE GUARDS WERE SEVERELY BENT. INVESTIGATION RESULTS INDICATE THAT LATERAL STRESS MAY HAVE BEEN PLACED ON THE FOOT OF THE GUARD, WHICH MAY HAVE POTENTIALLY CAUSED THE BLADE TO BREAK, HOWEVER, THIS CANNOT BE CONFIRMED. THE ROOT CAUSE IS UNDETERMINED. THE BLADE GUARDS ASSOCIATED WITH THIS MDR ARE AS FOLLOWS; PART NUMBER: 7207003000, SERIAL NUMBER: (B)(4), PART NUMBER: 7207003000, SERIAL NUMBER: (B)(4).