PHYNOX AVM CLIP APP FCPSTUB SHAFT110MM

Description of Event or Problem

ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00062 (400500399 + FE907K), 9610612-2021-00063 (400500400 + FE909K). INVOLVED COMPONENTS. FE923K - AVM MICROCLIP PHYNOX STRAIGHT3MM - UNKNOWN. FE923K - AVM MICROCLIP PHYNOX STRAIGHT3MM - UNKNOWN.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION AND CORRECTION: AFTER ADDITIONAL INFORMATION WAS RECEIVED, THIS CASE WAS REEVALUATED AND EVALAUATED AS BEEING A REPORTABLE INCIDENT DUE TO AN UPDATE OF THE PATIENT HARM. EVALUATION WAS CHANGED FROM MALFUNCTION TO ADVERSE EVENT DU TO THE NECESSITY OF AN ADDITIONAL MEDICAL INTERVENTION. INVESTIGATION RESULTS: THE LEADING PRODUCTS ARRIVED IN A CLEAN STATUS WITHOUT VISIBLE DAMAGE. INVESTIGATION WAS CARRIED OUT VISUALLY AND MICROSCOPICALLY. WE MADE A VISUAL INSPECTION OF THE PRODUCTS FE907K AND FE909K AND NO DEVIATION COULD BE DETECTED. FURTHERMORE THE PRODUCTS WERE SEND TO THE QUALITY ASSURANCE OF THE PRODUCTION DEPARTMENT FOR FURTHER ANALYSIS. THE PRODUCTS ARE ACCORDING TO THE TEST PLAN. NO FAULT COULD BE DETECTED ON THE PRODUCTION SIDE. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE AVAILABLE LOT NUMBER AND WERE FOUND TO BE ACCORDING TO OUR SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. REVIEW OF THE COMPLAINT HISTORY REVEALED THAT NO SIMILAR COMPLAINTS HAVE BEEN FILED AGAINST PRODUCTS FROM THIS BATCH NUMBER. THE REVIEW OF THE RISK ASSESSMENT REVEALED THAT THE OVERALL RISK LEVEL (SEVERITY X PROBABILITY OF OCCURRENCE) ACCORDING TO DIN EN ISO 14971 IS NO LONGER ACCEPTABLE. THE NEED TO REVISIT THE RISK ASSESSMENT WILL BE REQUESTED AND FURTHER EVALUATED BY THE RESPONSIBLE DEPARTMENT. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN, BECAUSE NO DEVIATIONS WERE FOUND ON THE RECEIVED PRODUCTS. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. IN THE EVENT THAT THE COMPLAINT PRODUCT WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. BASED UPON THE INVESTIGATIONS RESULTS A CAPA IS NOT NECESSARY.

Additional Manufacturer Narrative

ACCORDING TO UPDATED INVESTIGATION REPORT THE HINTS FOR CORRECT USAGE OF THE DEVICES CAN BE FOUND IN THE INSTRUCTION FOR USE (IFU). DURING ASSEMBLING AND USAGE AS WELL AS INSPECTION AN MAINTENANCE POINTS AND CHECKS SHOULD BE OBSERVED BEFORE USAGE DURING SURGERY. E.G: "ENSURE THAT THE CORRECT POSITION OF THE JAW PIECE WITH PULLING ROD IS MAINTAINED" "CHECK THAT THE PRODUCT FUNCTIONS CORRECTLY." (SEE IFU OF THE DEVICE). BATCH HISTORY REVIEW: REVIEW OF THE COMPLAINT HISTORY REVEALED THAT NO SIMILAR COMPLAINTS HAVE BEEN FILED AGAINST PRODUCTS FROM THIS BATCH NUMBER. THE REVIEW OF RISK ASSESSMENT REVEALED THAT THE OVERALL RISK LEVEL (SEVERITY 3(5) X PROBABILITY OF OCCURRENCE 2(5).

Description of Event or Problem

ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00062 (B)(4) + FE907K. 9610612-2021-00063 (B)(4) + FE909K. INVOLVED COMPONENTS: FE923K AVM MICROCLIP PHYNOX STRAIGHT3MM UNKNOWN. FE923K AVM MICROCLIP PHYNOX STRAIGHT3MM UNKNOWN.

Additional Manufacturer Narrative

MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FE909K - PHYNOX AVM CLIP APP FCPSTUB SHAFT110MM. ACCORDING TO THE COMPLAINT DESCRIPTION, BOTH CLIP APPLIERS DO NOT WORK AS DESIRED: THE CLIPS ARE OPENED SO MUCH THAT THEY BECOME UNUSABLE. IN ADDITION, THE CLIPS WERE NOT RELEASED WITHOUT PROBLEMS. THE LOCKING KNOBS DO NOT WORK PROPERLY. SURGERY HAD TO BE FINISHED WITH ANOTHER SET. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00062 ((B)(4) + FE907K). INVOLVED COMPONENTS: FE923K - AVM MICROCLIP PHYNOX STRAIGHT3MM - UNKNOWN. FE923K - AVM MICROCLIP PHYNOX STRAIGHT3MM - UNKNOWN.