WYNMAN CARB CROWN GRIPPER
Received Oct 14, 2016
Report 2523190-2016-00164 · MDR key 6029644
Device
Generic name
M51 - General Dentistry
Manufacturer
Integra York, Pa Inc.Catalog number
72-10TC
Lot number
UNKNOWN
Product problems
- Break
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
ON 9/28/16 INTEGRA INVESTIGATION COMPLETED. MANUFACTURE DATE UNKNOWN. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULTS: FAILURE ANALYSIS - A GRIPPER IN USED CONDITION, NOT SHOWING ANY UNUSUAL MARKINGS, SHOWING WEAR, STAINING AND DISCOLORATION, BATTERED FINISH, AND BROKEN INSERT. DURING THE VISUAL INSPECTION OF THE INSTRUMENT, IT IS NOTICED THAT THE FINISH IS WORN AND THERE IS STAINING/DISCOLORATION. IT IS ALSO NOTICED THAT THE INSERT IS BROKEN ON ONE OF THE TIPS. THE DAMAGE TO THE INSERT APPEARS TO HAVE STARTED AS A HAIRLINE FRACTURED, LEADING TO THE BREAKAGE. THE COMPLAINT REPORT IS CONFIRMED. DEVICE HISTORY EVALUATION - NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY: NONE. VARIANCE AUTHORIZATION / DEVIATION HISTORY: NONE. ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY: THERE IS NO APPLICABLE ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY. CORRECTIVE ACTION PREVENTIVE ACTION HISTORY/CORRECTIONS: NONE. HEALTH HAZARD EVALUATION HISTORY: NONE. CONCLUSION: THE ROOT CAUSE HAS NOT BEEN IDENTIFIED AS A WORKMANSHIP OR MATERIAL DEFICIENCY.
Description of Event or Problem
CUSTOMER INITIALLY REPORTS THE INSERT BROKE WHILE USING. ON (B)(6) 2016 DOCTOR REPORTS HE WAS GRIPPING A CROWN WHEN A TIP OF THE CARBIDE INSERT BROKE OFF IN THE MOUTH AND WAS RETRIEVED. NO HARM DONE.