STERNUM BLADE
Received Dec 17, 2015 · Event occurred Sep 25, 2015
Report 0001811755-2015-04568 · MDR key 5305337
Device
Generic name
Blade, Saw, Surgical, Cardiovascular
Manufacturer
Stryker Instruments-kalamazooCatalog number
0298097101
Lot number
15238017
Product problems
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE STERNUM BLADE SUBJECT TO THIS INVESTIGATION WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. IT WAS VISUALLY CONFIRMED THAT THE BLADE WAS BROKEN. INVESTIGATION RESULTS INDICATE THAT THE BREAK OBSERVED IN THE RETURNED BLADE COULD NOT BE REPLICATED WITH OR WITHOUT USING A STERNUM GUARD. A DEFINITIVE ROOT CAUSE FOR THE BLADE BREAKAGE CANNOT BE DETERMINED IN THIS CASE.
Description of Event or Problem
IT WAS REPORTED THAT AFTER THE SURGEON PERFORMED A CUT TO THE PATIENT'S BREASTBONE, IT WAS NOTED THAT THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THE BROKEN FRAGMENT WAS FOUND ON THE PATIENT'S CHEST AND WAS IMMEDIATELY REMOVED. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Additional Manufacturer Narrative
AWAITING DEVICE EVALUATION. A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE.
Description of Event or Problem
IT WAS REPORTED THAT AFTER THE SURGEON PERFORMED A CUT TO THE PATIENT'S BREASTBONE, IT WAS NOTED THAT THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THE BROKEN FRAGMENT WAS FOUND ON THE PATIENT'S CHEST AND WAS IMMEDIATELY REMOVED. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.