STERNUM BLADE
Received Jun 28, 2012 · Event occurred Jun 4, 2012
Report 9616696-2012-00182 · MDR key 2646066
Device
Product problems
- Bent
- Break
- Detachment Of Device Component
Patient
UNK
- No Information
Narrative
Description of Event or Problem
OUR SALES REP UWE BRILL REPORTED THAT DURING A SURGERY PROCEDURE A PIECE OF THE BLADE WAS BROKEN OFF AFTER THE STERNUM BLADE GUARD WAS BENT. THE PIECE WAS FULLY REMOVED FROM THE PT. BECAUSE OF THIS THERE WAS A DELAY OF 30 MINS., A REPLACEMENT WAS AVAILABLE AND THE SURGERY WAS SUCCESSFULLY COMPLETED AT THE END.
Additional Manufacturer Narrative
THE BLADE SUBJECT TO THIS INVESTIGATION WAS RETURNED TO THE MFR FOR EVAL, IT WAS VISUALLY CONFIRMED THE BLADE WAS BROKEN ALONG THE SHAFT. THE RETURNED BLADE WAS MEASURED WHERE POSSIBLE AND ALL CRITICAL SPECIFICATIONS WERE MET. LOT NUMBER INFO HAS NOT BEEN PROVIDED TO PERMIT FURTHER INVESTIGATION. INVESTIGATION RESULTS INDICATE THAT THE BLADE GUARD FIRST BECAME DISTORTED DUE TO PRYING WHICH IN TURN PUT EXCESSIVE PRESSURE ON THE BLADE, WHICH MAY HAVE POTENTIALLY CAUSED THE BLADE TO BREAK, HOWEVER, THIS CANNOT BE CONFIRMED. THE ROOT CAUSE IS UNDETERMINED.