MalfunctionDWH
STRYKER PERFORMANCE SERIES STERNUM BLADE(30.5 X 1MM)
Received Apr 7, 2017 · Event occurred Mar 10, 2017
Report 0001811755-2017-00835 · MDR key 6471188
Device
Generic name
Blade, Saw, Surgical, Cardiovascular
Manufacturer
Stryker Instruments-kalamazooCatalog number
6207097101
Lot number
UNKNOWN
Product problems
- Break
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE QUALITY INVESTIGATION IS COMPLETE. BLADE NOT AVAILABLE FOR RETURN.
Description of Event or Problem
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE STERNUM BLADE GUARD BENT WHILE CUTTING THE STERNUM AND THE BLADE BROKE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.