STERNUM BLADE
Received Feb 12, 2013 · Event occurred Jan 16, 2013
Report 0001811755-2013-00221 · MDR key 2956838
Device
Generic name
Blade, Saw, Surgical, Cardiovascular
Manufacturer
Stryker Instruments-kalamazooCatalog number
0298097100
Lot number
12278027
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING AN AORTIC VALVE REPLACEMENT SURGERY, THE BLADE BROKE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN PROVIDED.
Additional Manufacturer Narrative
THE RETURNED BLADE WAS MEASURED WHERE POSSIBLE AND ALL CRITICAL SPECIFICATIONS WERE MET. MANUFACTURING RECORDS WERE REVIEWED, NO ISSUES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. INVESTIGATION RESULTS INDICATE THAT THE BREAK POTENTIALLY OCCURRED DUE TO PRYING OR BENDING OF THE BLADE DURING USE, BUT THIS CANNOT BE CONFIRMED. THE ROOT CAUSE IS UNDETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT DURING AN AORTIC VALVE REPLACEMENT SURGERY, THE BLADE BROKE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN PROVIDED.
Additional Manufacturer Narrative
THE BLADE SUBJECT TO THIS MDR WAS RETURNED FOR EVALUATION. IT WAS VISUALLY CONFIRMED THAT THE BLADE BROKE AT THE MOUNT. THE INVESTIGATION IS ONGOING.