FLEX-R 'S' #20 25MM
Received May 20, 2015 · Event occurred Apr 28, 2015
Report 2523190-2015-00025 · MDR key 4790480
Device
Product problems
- Break
- Entrapment of Device
Patient
51 YR
- No Consequences Or Impact To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
CUSTOMER INITIALLY REPORTS THAT 2 FILES BROKE OFF IN PATIENTS MOUTHS. PIECE COULD NOT BE REMOVED FROM ROOT CANAL, NO ILL EFFECTS SEEN. NUMBER 2 OF 2 RELATED COMPLAINTS.
Additional Manufacturer Narrative
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.
Additional Manufacturer Narrative
ON 06/15/2015 INTEGRA COMPLETED INVESTIGATION. RESULTS- FAILURE ANALYSIS: DENTAL FILES RETURNED IN USED CONDITION, NOT SHOWING ANY UNUSUAL MARKINGS. THE FILES WERE SHOWING WEAR UPON VISUALLY INSPECTING THE FILES, IT IS NOTICED THAT SOME OF THE FILES ARE BENT AND ONE WITH A BROKEN TIP. QUALITY INSPECTOR TESTED THE BLADES FOR BEND AND TORQUE, AND THE FILES TESTED WITHIN DEFINED SPECIFICATIONS. WITHOUT KNOWING HOW MUCH PRESSURE WAS USED DURING THE PROCEDURE, THE CAUSE OF THE COMPLAINT IS UNDETERMINED. 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: NONE, HEALTH HAZARD EVALUATION HISTORY: NONE. CONCLUSION: THE COMPLAINT REPORT CANNOT BE CONFIRMED, DUE TO THE INSTRUMENT TESTING WITHIN DEFINED SPECIFICATION.