STERNUM BLADE
Received Jul 18, 2014 · Event occurred Jun 24, 2014
Report 0001811755-2014-02573 · MDR key 3943781
Device
Generic name
Blade, Saw, Surgical, Cardiovascular
Manufacturer
Stryker Instruments-kalamazooCatalog number
0277087100
Lot number
UNKNOWN
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE QUALITY INVESTIGATION IS COMPLETE. DEVICE NOT RETURNED TO THE MANUFACTURER.
Description of Event or Problem
IT WAS REPORTED THAT DURING A PROCEDURE THE SAW BLADE BROKE DURING THE CUT. WHEN THE BLADE BREAK WAS NOTICED AN X-RAY WAS TAKEN AND THE OTHER PART OF THE BLADE WAS FOUND IN THE PATIENT. IT WAS FURTHER REPORTED THAT THIS RESULTED IN A SURGICAL DELAY OF 15-20 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Additional Manufacturer Narrative
DEVICE RETURN HAS BEEN REQUESTED. 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 DURING A PROCEDURE THE SAW BLADE BROKE DURING THE CUT. WHEN THE BLADE BREAK WAS NOTICED, AN X-RAY WAS TAKEN AND THE OTHER PART OF THE BLADE WAS FOUND IN THE PATIENT. IT WAS FURTHER REPORTED THAT THIS RESULTED IN A SURGICAL DELAY OF 15-20 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.