OSCILLATING AND SAGITTAL BLADE
Received Jan 7, 2011 · Event occurred Nov 30, 2010
Report 9616696-2011-00003 · MDR key 1985570
Device
Generic name
Saw Blades & Accessories
Manufacturer
Stryker Ireland Ltd.Catalog number
2296003111
Lot number
UNK
Product problems
- Break
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE BLADE AND THE BROKEN PIECE SUBJECT TO THIS MDR WERE RETURNED FOR EVAL. IT WAS VISUALLY CONFIRMED THAT THE BLADE WAS BROKEN AT THE MOUNT. THE RETURNED BLADE WAS MEASURED WHERE POSSIBLE AND ALL CRITICAL SPECIFICATIONS WERE MET. LOT NUMBER INFO HAS NOT BEEN PROVIDED TO PERMIT FURTHER INVESTIGATION. THE ROOT CAUSE UNDETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT AT THE END OF A SURGICAL PROCEDURE, WHERE THE MANDIBLE BONE WAS BEING CUT, IT WAS NOTED THAT THE BLADE WAS BROKEN AT THE MOUNT. IT WAS ALSO REPORTED THAT THE BROKEN PIECES DID NOT FALL INTO THE SURGICAL SITE. IT WAS FURTHER REPORTED THAT THERE WAS NO PT OR USER INJURY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.