MalfunctionDWH
MED NARROW BLD (25.0MM X5.5MM)
Received Mar 10, 2010 · Event occurred Feb 8, 2010
Report 9616696-2010-00203 · MDR key 1634257
Device
Generic name
Saw Blades And Accessories
Manufacturer
Stryker Ireland Ltd.Catalog number
5400003414
Lot number
09233017
Product problems
- Break
- Detachment Of Device Component
- Difficult to Remove
Patient
UNK
- Device Embedded In Tissue or Plaque
Narrative
Additional Manufacturer Narrative
THE BLADE SUBJECT TO THIS MDR WAS RETURNED FOR EVAL. IT WAS VISUALLY CONFIRMED THAT A BLADE TOOTH HAD BROKEN OFF. THE ROOT CAUSE FOR THIS BREAKAGE HAS NOT BEEN DETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT A BLADE TOOTH BROKE OFF DURING A BUNIONECTOMY. IT WAS FURTHER REPORTED THAT IT WAS NOT POSSIBLE TO RETRIEVE THE TOOTH FROM THE PT AND THAT AN X-RAY PERFORMED ON THE PT DID NOT DETECT THE PRESENCE OF THE TOOTH. NO ADVERSE CONSEQUENCES WERE REPORTED.