STERNUM BLADE
Received Sep 27, 2022 · Event occurred Sep 1, 2022
Report 3015967359-2022-01829 · MDR key 15493447
Device
Generic name
Blade, Saw, Surgical, Cardiovascular
Manufacturer
Stryker Instruments-a Division Of Stryker CorpModel number
0298097100Catalog number
0298097100
Lot number
22139037
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 UPON RECEIPT BY THE CUSTOMER, THE BLADE WAS BROKEN. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE AND THERE WAS NO DELAY OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
H6: THE QUALITY INVESTIGATION IS COMPLETE.
Additional Manufacturer Narrative
A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE. OTHER TEXT : AWAITING DEVICE RETURN.
Description of Event or Problem
IT WAS REPORTED THAT UPON RECEIPT BY THE CUSTOMER, THE BLADE WAS BROKEN. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE AND THERE WAS NO DELAY OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.