STERNUM BLADE, OFFSET (31.7 X 0.64 X 6.3MM)
Received Sep 6, 2022 · Event occurred Jul 27, 2022
Report 3015967359-2022-01746 · MDR key 15362328
Device
Generic name
Blade, Saw, Surgical, Cardiovascular
Manufacturer
Stryker Instruments-a Division Of Stryker CorpModel number
0298097101Catalog number
0298097101
Lot number
22030037
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 REPORT 2000330000-2022-8042 THAT THE STERNAL SAW BLADE BROKE IN HALF WHILE THE SURGEON WAS SAWING/OPENING THE STERNUM. 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.
Description of Event or Problem
IT WAS REPORTED VIA MEDWATCH REPORT (B)(4) THAT THE STERNAL SAW BLADE BROKE IN HALF WHILE THE SURGEON WAS SAWING/OPENING THE STERNUM. 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.