STERNUM BLADE
Received Jun 30, 2014 · Event occurred Jun 9, 2014
Report 0001811755-2014-02315 · MDR key 3902009
Device
Generic name
Blade, Saw, Surgical, Cardiovascular
Manufacturer
Stryker Instruments-kalamazooCatalog number
0298097100
Lot number
UNKNOWN
Product problems
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE BLADE BROKE DURING A PROCEDURE. IT WAS FURTHER REPORTED THAT THERE WAS A 5 MINUTE DELAY AS A RESULT. AN X-RAY WAS TAKEN TO ENSURE NO PIECE WAS LEFT BEHIND. THERE WAS NO PATIENT IMPACT OR ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED FOR EVALUATION. THE QUALITY INVESTIGATION IS COMPLETE.
Additional Manufacturer Narrative
THE DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE. DEVICE NOT YET RETURNED TO MANUFACTURER.
Description of Event or Problem
IT WAS REPORTED THAT THE BLADE BROKE DURING A PROCEDURE. IT WAS FURTHER REPORTED THAT THERE WAS A 5 MINUTE DELAY AS A RESULT. AN X-RAY WAS TAKEN TO ENSURE NO PIECE WAS LEFT BEHIND. THERE WAS NO PATIENT IMPACT OR ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.