WYNMAN CARB CROWN GRIPPER
Received Sep 14, 2016
Report 2523190-2016-00139 · MDR key 5948938
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 8/31/2016 INTEGRA INVESTIGATION COMPLETED. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULTS: FAILURE ANALYSIS - A GRIPPER WAS RETURNED IN USED CONDITION, SHOWING WEAR, STAINING AND DAMAGED INSERTS. WHILE DOING THE VISUAL INSPECTION OF THE INSTRUMENT, IT IS NOTICED THAT THERE IS STAINING AND DISCOLORATION AT THE INSERT AREA. IT IS ALSO NOTICED THAT THE INSERTS ARE SLIGHTLY WORN. WITHOUT KNOWING HOW THE INSTRUMENT WAS HANDLED OR MAINTAINED DURING AUTOCLAVING, THE CAUSE IS UNDETERMINED. 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 INSERTS "DISSOLVED" OR DISAPPEARED AFTER STERILIZING, IT WAS USED AND IT DAMAGED A CROWN. ON 9/1/2016 NO FURTHER INFORMATION AVAILABLE.