STERNUM BLADE
Received Aug 17, 2010 · Event occurred Jul 19, 2010
Report 9616696-2010-00266 · MDR key 1819363
Device
Generic name
Saw Blades & Accessories
Manufacturer
Stryker Ireland LtdCatalog number
0298097100
Lot number
10118017
Product problems
- Break
- Detachment Of Device Component
- Component Falling
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A VALVE REPLACEMENT PROCEDURE, THE STERNUM BLADE BROKE. IT WAS ALSO REPORTED THAT THE BROKEN PIECES WERE RETRIEVED USING A FORCEPS AND THAT THE SURGEON HAS NO CONCERNS ON PIECES BEING LEFT BEHIND. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES FOR THE PT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Additional Manufacturer Narrative
THE BLADE SUBJECT TO THIS MDR WAS RETURNED FOR EVAL. IT WAS VISUALLY CONFIRMED THAT THE BLADE WAS BROKEN JUST ABOVE THE MOUNT SECTION. THE RETURNED BLADE WAS MEASURED WHERE POSSIBLE AND ALL CRITICAL SPECIFICATIONS WERE MET. THE MFG RECORDS WERE REVIEWED, NO ISSUES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. THE ROOT CAUSE IS UNDETERMINED.