ION NITRIDED BLADE
Received Nov 13, 2019 · Event occurred Oct 16, 2019
Report 0001811755-2019-03758 · MDR key 9318736
Device
Generic name
Instrument, Cast Removal, Ac-powered
Manufacturer
Stryker Instruments-kalamazooModel number
0940023000Catalog number
0940023000
Lot number
UNKNOWN
Product problems
- Fracture
- Fracture
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
THE REPORTED EVENT, FOR BLADE BREAKAGE, WAS NOT CONFIRMED AS THE BLADE WAS NOT RETURNED FOR EVALUATION. WITHOUT THE BLADE, THE ROOT CAUSE CANNOT BE DETERMINED.DEVICE NOT AVAILABLE FOR RETURN.
Description of Event or Problem
IT WAS REPORTED VIA THE CUSTOMER THAT, THEY OBSERVED A BROKEN BLADE WITHIN THEIR INVENTORY. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, AND THERE WAS NO PATIENT INVOLVEMENT, NO DELAY AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE. AWAITING RETURN OF DEVICE TO MANUFACTURER.
Description of Event or Problem
IT WAS REPORTED VIA THE CUSTOMER THAT, THEY OBSERVED A BROKEN BLADE WITHIN THEIR INVENTORY. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, AND THERE WAS NO PATIENT INVOLVEMENT, NO DELAY AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.