STERNUM BLADE
Received Jul 10, 2012 · Event occurred Jun 1, 2012
Report 9616696-2012-00192 · MDR key 2657505
Device
Product problems
- Break
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A CORONARY ARTERY BYPASS SURGERY, 3 STERNUM BLADES BROKE ALONG THE SHAFT. IT WAS ALSO REPORTED THAT THERE WAS NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT ANOTHER BLADE WAS READILY AVAILABLE AND THERE WAS A FEW MINUTES DELAY TO THE PROCEDURE.
Additional Manufacturer Narrative
THE 3 BLADES SUBJECT TO THIS MDR WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. IT WAS VISUALLY CONFIRMED THAT THE 3 BLADES WERE BROKEN ALONG THE SHAFT. MANUFACTURING RECORDS WERE REVIEWED, NO ISSUES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. THE ROOT CAUSE IS UNDETERMINED. THE BLADE GUARD ASSOCIATED WITH THIS MDR IS AS FOLLOWS; PART NUMBER: 4107008000, SERIAL NUMBER: (B)(4).