STERNUM BLADE
Received Apr 7, 2020 · Event occurred Oct 3, 2019
Report 0001811755-2020-00879 · MDR key 9932803
Device
Generic name
Blade, Saw, Surgical, Cardiovascular
Manufacturer
Stryker Instruments-kalamazooModel number
0298097100Catalog number
0298097100
Lot number
19089027
Product problems
- Fracture
- 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. AWAITING DEVICE RETURN.
Description of Event or Problem
IT WAS REPORTED THAT, DURING A MEDIAN STERNOTOMY, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Additional Manufacturer Narrative
H6: THE QUALITY INVESTIGATION IS COMPLETE.
Description of Event or Problem
IT WAS REPORTED THAT, DURING A MEDIAN STERNOTOMY, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.