N
Patient 1
(B)(4). INVESTIGATION: THE INVESTIGATION WAS CARRIED OUT VISUALLY AND MICROSCOPICALLY. HERE WE FOUND NO MAL-ALIGNED JAW OR ANOTHER FAILURE. ADDITIONAL WE DETECTED TRACES OF USAGES. FURTHERMORE, THE IMPLANT WAS SENT TO THE QUALITY ASSURANCE OF THE PRODUCTION DEPARTMENT FOR A CLOSING FORCE TEST. THE CLOSING FORCE HAS BEEN EXAMINED WITH THE CHECK WEIGHER FOR CLIP ID (B)(4). ACCORDING TO SPECIFICATION (1.96 N +/- 7.5 % (MIN. 2.107 N, MAX. 1.813)) IS THE CLOSING FORCE IN THE ALLOWABLE TOLERANCE WITH 1.88 N. IN ADDITION, THE COMPLAINT COULD NOT BE RECONSTRUCTED WITH SCISSORING. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE LOT NUMBER (52126145) AND FOUND TO BE ACCORDING TO THE SPECIFICATION, VALID AT THE TIME OF PRODUCTION. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THIS BATCH CONCLUSION AND ROOT CAUSE: NO FAILURE WAS FOUND. RATIONALE: DUE TO OUR INVESTIGATION NO FAILURE WAS FOUND. ACCORDING TO THE QUALITY STANDARD AND TO THE DHR FILES A PRODUCTION ERROR AND A MATERIAL DEFECT CAN BE EXCLUDED. SINCE THESE CLIPS ARE SUBJECT TO A 100% INSPECTION OF SURFACE, GEOMETRY AND CLOSING FORCE, A DELIVERY CONDITION WITH POOR GEOMETRY IS EXCLUDED. ACCORDING TO THE REPORT OF THE QUALITY ASSURANCE OF THE PRODUCTION DEPARTMENT THE INSTRUMENT COMPLIES WITH OUR SPECIFICATIONS. NO CAPA NECESSARY.