STERNUM BLADE
Received Jun 18, 2013 · Event occurred May 16, 2013
Report 0001811755-2013-01425 · MDR key 3176013
Device
Generic name
Blade, Saw, Surgical, Cardiovascular
Manufacturer
Stryker Instruments-kalamazooCatalog number
0298097100
Lot number
12251027
Product problems
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
MANUFACTURING RECORDS WERE REVIEWED, NO ISSUES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. THE RETURNED BLADES WERE MEASURED WHERE POSSIBLE AND ALL CRITICAL SPECIFICATIONS WERE MET. INVESTIGATION RESULTS INDICATE THE BREAK ON THE BLADES WERE CONSISTENT WITH THE BLADES BEING BENT TOWARDS THE BLADE GUARD WHILE CUTTING. THIS IMPACT FORCE COMBINED WITH A BENDING FORCE POTENTIALLY CAUSED THE BLADES TO BREAK; HOWEVER, THIS CANNOT BE CONFIRMED. THE ROOT CAUSE IS UNDETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, 2 BLADES BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THERE WAS A MINIMAL DELAY AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.