MalfunctionDWH
STERNUM BLADE
Received May 23, 2012 · Event occurred Apr 18, 2012
Report 9616696-2012-00134 · MDR key 2588562
Device
Product problems
- Break
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE BLADE SUBJECT TO THIS INVESTIGATION WAS NOT RETURNED TO THE MFR FOR EVAL. MFR RECORDS WERE REVIEWED, NO ISSUES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. THE ROOT CAUSE IS UNDETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT DURING A STERNOTOMY PROCEDURE, THE BLADE BROKE AT THE CUTTING END. IT WAS ALSO REPORTED THAT THERE WAS NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WAS A DELAY OF 15 MINUTES AND A REPLACEMENT BLADE WAS AVAILABLE.