InjuryDWH
SYSTEM 6 STERNUM BLD-30.5X1MM
Received Sep 1, 2009 · Event occurred Jul 14, 2009
Report 9616696-2009-00124 · MDR key 1548982
Device
Generic name
Saw Blades & Accessories
Manufacturer
Stryker Ireland LtdCatalog number
6207097101
Lot number
UNK
Product problems
- Break
- Component Falling
Patient
UNK
- No Code Available
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING AN AORTIC VALVE REPLACEMENT (AVR) SURGERY, THE STERNAL SAW BLADE BROKE. IT WAS ALSO REPORTED THAT THE BROKEN PIECE WAS RETRIEVED DURING A REVISION SURGERY THE NEXT DAY AFTER X-RAY. IT WAS FURTHER REPORTED THAT NO ADDITIONAL MEDICATION WAS REQUIRED AS A RESULT OF THE BREAKAGE.
Additional Manufacturer Narrative
THE BLADE SUBJECT TO THIS MDR HAS NOT BEEN RETURNED TO MFR FOR EVAL. PRODUCT LOT # INFO HAS NOT BEEN PROVIDED TO PERMIT FURTHER INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE IS UNDETERMINED.