UNKNOWN_INSTRUMENTSTIRE_PRODUCT
Received Sep 8, 2014 · Event occurred Aug 12, 2014
Report 0001811755-2014-03178 · MDR key 4067326
Device
Product problems
- Break
Patient
Not reported
- No Patient Involvement
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE BUR BROKE IN THE ATTACHMENT. IT WAS REPORTED THAT THIS HAPPENED AFTER A CASE AND THERE WAS NO PATIENT IMPACT AS A RESULT OF THE EVENT.
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED. QUALITY INVESTIGATION IS COMPLETE.
Additional Manufacturer Narrative
THE DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE. PRODUCT NOT YET RETURNED TO MANUFACTURER.
Description of Event or Problem
IT WAS REPORTED THAT BUR BROKE IN THE ATTACHMENT. THERE WAS NO MEDICAL INTERVENTION, SURGICAL DELAY OR ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT