UNKNOWN_INSTRUMENTSTIRE_PRODUCT
Received Aug 26, 2016 · Event occurred Jul 29, 2016
Report 0001811755-2016-02014 · MDR key 5908301
Device
Product problems
- Break
- Break
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
BUR BREAKAGE CAN BE MULTIFACTORIAL: USER APPLIED SIDE LOADING, BUR EXPOSURE, RUNNING SPEED AS WELL AS ATTACHMENT AND DRILL CONDITIONS. THE ROOT CAUSE IS UNDETERMINED.
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
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.