MalfunctionEIS
WYNMAN CARB CROWN GRIPPER
Received Nov 10, 2016 · Event occurred Sep 20, 2016
Report 8010252-2016-00001 · MDR key 6092667
Device
Product problems
- Fracture
- Fracture
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS MANUFACTURED AND PUT INTO COMMERCIAL DISTRIBUTION PRIOR TO 1998, 18+ YEARS AGO. IT HAS BEEN USED LONG PAST ITS EXPECTED LIFE, BEING SUBJECT TO INTENSIVE REUSE, AS EVIDENCED BY ITS EXTREMELY WORN CONDITION, BOTH OVERALL AND OF THE INSERTS IN PARTICULAR.
Description of Event or Problem
FACILITY REPORTS THAT THE INSERT BROKE WHILE USING. THE DOCTOR REPORTS THAT HE WAS GRIPPING A CROWN WHEN A TIP OF THE CARBIDE INSERT BROKE OFF IN THE MOUTH AND WAS RETRIEVED. NO HARM DONE.