UNKNOWN_INSTRUMENTSTIRE_PRODUCT
Received Jan 23, 2017 · Event occurred Dec 27, 2016
Report 0001811755-2017-00108 · MDR key 6269899
Device
Product problems
- Break
- Break
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS ONLY A PARTIAL PIECE OF THE DEVICE WAS RETURNED. THE QUALITY INVESTIGATION IS CLOSED.
Description of Event or Problem
IT WAS REPORTED THAT DURING SERVICE CONDUCTED AT THE MANUFACTURER A BROKEN PIECE OF A BLADE WAS FOUND INSIDE THE HANDPIECE SAW. 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 PIECE OF A BLADE WAS FOUND INSIDE THE HANDPIECE SAW. 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.