MalfunctionDWH
SAGITTAL BLADE
Received Mar 13, 2009 · Event occurred Feb 13, 2009
Report 9616696-2009-00024 · MDR key 1358330
Device
Generic name
Saw Blades & Accessories
Manufacturer
Stryker Ireland Ltd.Catalog number
2108302000
Lot number
08298017
Product problems
- Break
- Replace
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A PROCEDURE, THAT THE BLADE BROKE AT THE MOUNT. IT WAS FURTHER REPORTED THAT THE BROKEN PIECES DID NO FALL INTO THE SURGICAL SITE. IT WAS REPORTED THAT ANOTHER BLADE WAS AVAILABLE AND THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Additional Manufacturer Narrative
DEVICE IS IN TRANSIT TO MANUFACTURER FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN EVALUATED.