STERNUM BLADE
Received Dec 21, 2015 · Event occurred Nov 27, 2015
Report 0001811755-2015-04649 · MDR key 5313205
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
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 DURING A SURGICAL PROCEDURE ON THE CHEST, THE BLADE BROKE AT THE MOUNT. 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
THE BLADE SUBJECT TO THIS EVENT WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. IT WAS VISUALLY CONFIRMED THAT THE BLADE WAS BROKEN. THE RETURNED BLADE WAS MEASURED WHERE POSSIBLE AND ALL CRITICAL SPECIFICATIONS WERE MET. TESTS PERFORMED ON SAMPLE BLADES COULD NOT REPLICATE THE FAILURE. A DEFINITIVE ROOT CAUSE FOR THE BLADE BREAKAGE CANNOT BE DETERMINED IN THIS CASE.
Description of Event or Problem
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE ON THE CHEST, THE BLADE BROKE AT THE MOUNT. 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.