STERNUM BLADE
Received Mar 6, 2017 · Event occurred Feb 3, 2017
Report 0001811755-2017-00715 · MDR key 6379923
Device
Generic name
Blade, Saw, Surgical, Cardiovascular
Manufacturer
Stryker Instruments-kalamazooCatalog number
0298097100
Lot number
UNKNOWN
Product problems
- Break
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE QUALITY INVESTIGATION IS COMPLETE.
Description of Event or Problem
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE STERNUM SAW BLADE BROKE. IT WAS ALSO REPORTED THAT 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
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, THE STERNUM SAW BLADE BROKE. IT WAS ALSO REPORTED THAT THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.