MalfunctionHTT
UNKNOWN_INSTRUMENTSTIRE_PRODUCT
Received Dec 22, 2015 · Event occurred Dec 7, 2015
Report 0001811755-2015-04684 · MDR key 5317467
Device
Product problems
- Break
Patient
Not reported
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
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.