UNKNOWN_INSTRUMENTSTIRE_PRODUCT
Received Mar 5, 2018 · Event occurred Jan 19, 2018
Report 0001811755-2018-00474 · MDR key 7312565
Device
Generic name
Blade, Saw, Surgical, Cardiovascular
Manufacturer
Stryker Instruments-kalamazooCatalog number
UNK_ICO
Product problems
- Break
- Break
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE. AWAITING DEVICE RETURN TO MANUFACTURER.
Description of Event or Problem
IT WAS REPORTED THAT A BLADE WAS BROKEN IN THE ASSOCIATED HANDPIECE DEVICE. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
THE QUALITY INVESTIGATION IS COMPLETE. DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem
IT WAS REPORTED THAT A BLADE WAS BROKEN IN THE ASSOCIATED HANDPIECE DEVICE. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.