UNKNOWN_INSTRUMENTSTIRE_PRODUCT
Received Dec 21, 2015 · Event occurred Dec 2, 2015
Report 0001811755-2015-04653 · MDR key 5313229
Device
Product problems
- Break
Patient
Not reported
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE.
Description of Event or Problem
IT WAS REPORTED THAT DURING SERVICE CONDUCTED AT THE MANUFACTURER A BROKEN BUR WAS FOUND INSIDE THE ATTACHMENT. 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
THE UNKNOWN BUR SUBJECT TO THIS INVESTIGATION WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IT WAS VISUALLY CONFIRMED THAT THE BUR WAS BROKEN. BASED ON REVIEW OF THE INFORMATION PROVIDED IN RELATION TO THIS REPORTED EVENT, THE ROOT CAUSE OF THIS EVENT IS UNDETERMINED. THE QUALITY INVESTIGATION IS COMPLETE.
Description of Event or Problem
IT WAS REPORTED THAT DURING SERVICE CONDUCTED AT THE MANUFACTURER A BROKEN BUR WAS FOUND INSIDE THE ATTACHMENT. 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.