MalfunctionDWH
STERNUM BLADE
Received Jun 30, 2022 · Event occurred Jun 3, 2022
Report 3015967359-2022-01227 · MDR key 14876485
Device
Generic name
Blade, Saw, Surgical, Cardiovascular
Manufacturer
Stryker Instruments-irelandModel number
0298097100Catalog number
0298097100
Lot number
UNKNOWN
Product problems
- Fracture
- Fracture
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A STERNOTOMY PROCEDURE, 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
THE QUALITY INVESTIGATION IS COMPLETE.