AMAL CAR. D/E LGE/JUM STE
Received Oct 16, 2017 · Event occurred Sep 21, 2017
Report 2523190-2017-00107 · MDR key 6951810
Device
Product problems
- Break
- Break
Patient
25 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
10/3/17 INTEGRA INVESTIGATION COMPLETED. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULTS: FAILURE ANALYSIS - A CARRIER WAS RETURNED IN USED CONDITION, NOT SHOWING ANY UNUSUAL MARKINGS. IT WAS NOTICED THAT THE LEVER IS BROKEN AND THE BARREL IS DETACHED. THE COMPLAINT REPORT IS CONFIRMED; DAMAGED WORN. DEVICE HISTORY EVALUATION - NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY: NONE. VARIANCE AUTHORIZATION / DEVIATION HISTORY: NONE. ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY: NONE. 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 BROKEN LEVERS AND TIPS. NO PATIENT INJURY. (B)(6) 2017 CUSTOMER REPORTS THE LEVER BROKE WHEN FILLING A MOLAR AND FELL INTO PATIENTS MOUTH, PIECE WAS RETRIEVED, NO HARM DONE.