STRYKER PERFORMANCE SERIES STERNUM BLADE(30.5 X 1MM)
Received Sep 26, 2019 · Event occurred Sep 11, 2019
Report 0001811755-2019-03087 · MDR key 9123743
Device
Generic name
Blade, Saw, Surgical, Cardiovascular
Manufacturer
Stryker Instruments-kalamazooCatalog number
6207097101
Lot number
UNKNOWN
Product problems
- Break
- Fracture
- Break
- Fracture
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE. DEVICE NOT AVAILABLE FOR RETURN.
Description of Event or Problem
IT WAS REPORTED THAT DURING A STERNOTOMY SURGERY, THE TIP OF THE BLADE BROKE. 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 REPORTED EVENT, FOR BLADE BREAKAGE, WAS NOT CONFIRMED AS THE BLADE WAS NOT RETURNED FOR EVALUATION. WITHOUT THE BLADE, THE ROOT CAUSE CANNOT BE DETERMINED. DEVICE NOT AVAILABLE FOR RETURN.
Description of Event or Problem
IT WAS REPORTED THAT DURING A STERNOTOMY SURGERY, THE TIP OF THE BLADE BROKE. 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.