STERNUM BLADE, OFFSET (31.7 X 0.64 X 6.3MM)
Received Sep 6, 2022 · Event occurred Jul 28, 2022
Report 3015967359-2022-01748 · MDR key 15362321
Device
Generic name
Blade, Saw, Surgical, Cardiovascular
Manufacturer
Stryker Instruments-a Division Of Stryker CorpModel number
0298097101Catalog number
0298097101
Lot number
21354027
Product problems
- Fracture
- Fracture
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE. AWAITING CONFIRMATION IF DEVICE IS AVAILABLE FOR RETURN.
Description of Event or Problem
IT WAS REPORTED VIA MEDWATCH 2000330000-2022-8043, THAT DURING A CORONARY ARTERY BYPASS GRAFT, WHILE SAWING THE STERNUM, THE BLADE BROKE IN HALF. 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. H3 OTHER TEXT : DEVICE NOT RETURNED.
Description of Event or Problem
IT WAS REPORTED VIA MEDWATCH (B)(4), THAT DURING A CORONARY ARTERY BYPASS GRAFT, WHILE SAWING THE STERNUM, THE BLADE BROKE IN HALF. 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.