STERNUM BLADE
Received Jun 19, 2013 · Event occurred May 22, 2013
Report 0001811755-2013-01431 · MDR key 3178142
Device
Generic name
Blade, Saw, Surgical, Cardiovascular
Manufacturer
Stryker Instruments-kalamazooCatalog number
0298097100
Lot number
13071017
Product problems
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A STERNUM PROCEDURE, THE BLADE BROKE IN TWO PIECES. IT WAS ALSO REPORTED THAT A BROKEN PIECE FELL INTO THE PATIENT; IT WAS LOCATED 2CMS FROM THE HEART AND WAS REMOVED. IT WAS FURTHER REPORTED THAT THERE WAS NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Additional Manufacturer Narrative
THE BLADE SUBJECT TO THIS MDR WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. IF THE PRODUCT IS RETURNED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE NOT RETURNED.
Description of Event or Problem
IT WAS REPORTED THAT DURING A STERNUM PROCEDURE, THE BLADE BROKE IN TWO PIECES. IT WAS ALSO REPORTED THAT A BROKEN PIECE FELL INTO THE PATIENT; IT WAS LOCATED 2CMS FROM THE HEART AND WAS REMOVED. IT WAS FURTHER REPORTED THAT THERE WAS NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Additional Manufacturer Narrative
THE EXACT ROOT CAUSE CANNOT BE DETERMINED. HOWEVER INVESTIGATION RESULTS INDICATE THAT THE CRACK ORIGINATED AT THE BOTTOM OF THE LAST TOOTH. THE POSSIBLE CAUSE IS OVERLOADING OF THE BLADE DURING THE SURGERY, BUT THIS CANNOT BE CONFIRMED.