MalfunctionDWH
STERNUM BLADE (100PK) OFFSET (32.0 X 0.79 X 6.3MM)
Received Jan 13, 2023 · Event occurred Nov 28, 2022
Report 3015967359-2023-00055 · MDR key 16156764
Device
Generic name
Blade, Saw, Surgical, Cardiovascular
Manufacturer
Stryker Instruments-a Division Of Stryker CorpCatalog number
0298097104
Lot number
UNKNOWN
Product problems
- Fracture
- Fracture
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE QUALITY INVESTIGATION IS COMPLETE. DEVICE NOT AVAILABLE FOR RETURN.
Description of Event or Problem
IT WAS REPORTED THAT DURING A PROCEDURE, THE BLADE BROKE AND HAD TO BE RETRIEVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.