SAGITTAL BLADE
Received Sep 17, 2009 · Event occurred Aug 17, 2009
Report 9616696-2009-00137 · MDR key 1505026
Device
Generic name
Saw Blade & Accessories
Manufacturer
Stryker Ireland LtdCatalog number
2108302000
Lot number
UNK
Product problems
- Break
- Detachment Of Device Component
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE BLADE PRODUCT SUBJECT TO THIS MDR, BROKE AT THE MOUNT TAB DURING A TOTAL KNEE PROCEDURE. IT WAS FURTHER REPORTED THAT THE BLADE CAME OUT OF THE HANDPIECE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS ALLEGED ISSUE.
Additional Manufacturer Narrative
LOT NUMBER INFO HAS BEEN SUPPLIED SO AS TO PERMIT FURTHER INVESTIGATION OF THIS POTENTIAL ISSUE. PRODUCT ALLEGEDLY INVOLVED IN THIS ISSUE WAS VISUALLY INSPECTED. IT IS CONFIRMED THAT ONE TAB HAS BROKEN OFF OF THE MOUNT OF THE BLADE. SCORE MARKINGS ON THE BLADE INDICATE THAT IT WAS INSERTED CORRECTLY IN TO THE HANDPIECE USED.