MalfunctionDWH
DUAL CUT SAGITTAL BLADE
Received Apr 29, 2008 · Event occurred Apr 2, 2008
Report 9616696-2008-00009 · MDR key 1051557
Device
Generic name
Saw Blades And Accessories
Manufacturer
Stryker InstrumentsCatalog number
4125127090
Lot number
080868017
Product problems
- Break
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
DEVICE NOT RETURNED FOR EVAL. WORK ORDER DOCUMENTATION REVIEWED AND ALL SPECS WERE MET.
Description of Event or Problem
IT WAS REPORTED THAT DURING A TOTAL KNEE PROCEDURE, THE BLADE BROKE. THE BROKEN BLADE DID NOT FALL INTO THE SURGICAL SITE AND THERE WAS NO PT INJURY ASSOCIATED.