PHYNOX AVM CLIP APP FCPSTUB SHAFT110MM

Additional Manufacturer Narrative

B1, B2 + H1: UPDATED TO ADVERSE EVENT AND SERIOUS INJURY DUE TO AN ADDITIONAL MEDICAL INTERVENTION THAT WAS REPORTED. INVESTIGATION RESULTS: VISUAL INVESTIGATION: INVESTIGATION WAS CARRIED OUT VISUALLY AND MICROSCOPICALLY. WE MADE A VISUAL INSPECTION OF THE PRODUCT FE907K AND OF THE BOTH PRODUCTS FE909K. HERE WE DETECTED THAT THE POSITION OF THE FORK TO RECEIVE THE CLIPS IS TWISTED TO THE GROOVE ON THE SHAFT. ADDITIONALLY THE PRODUCTS WERE SEND TO THE QUALITY ASSURANCE OF THE PRODUCTION DEPARTMENT FOR FURTHER ANALYSIS. ACCORDING TO THE QUALITY STANDARD, A PRODUCTION ERROR AND A MATERIAL DEFECT CAN BE EXCLUDED. THE DESCRIBED DEVIATION COULD HAVE BEEN CAUSED DUE TO TWISTED POSITION OF THE FORK. THE TWISTED POSITION WILL CAUSE THE CLIP TO COMPRESS TOO MUCH AND THEN NOT CLOSE PROPERLY. IF THE FORK IS TURNED TO THE CORRECT POSITION DURING USE, THE JAW SNAPS OPEN FURTHER AND THE CLIP FALLS OUT. THE CAUSE FOR THE TWISTED POSITION OF THE FORK TO RECEIVE THE CLIPS TO THE GROOVE COULD BE A FAULTY ASSEMBLY AFTER REPROCESSING. IN ADDITION, THE CONTROL COULD NOT HAVE BEEN CARRIED OUT AFTERWARDS OR MAY HAVE BEEN CARRIED OUT COMPLETELY. THE INSTRUCTIONS ACCORDING TO THE INSTRUCTION FOR USE SHOULD BE OBSERVED. 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 RISK ASSESSMENT REVEALED THAT THE OVERALL RISK LEVEL( (3(5) SEVERITY X 2(5) PROBABILITY OF OCCURRENCE) ACCORDING TO DIN EN ISO 14971 IS STILL ACCEPTABLE. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. BASED UPON THE INVESTIGATIONS RESULTS A CAPA IS NOT NECESSARY.

Description of Event or Problem

ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00389 (400511446 + FE909K). 9610612-2021-00189 (400504313 + FE909K). 9610612-2021-00237 (400505609 + FE907K). INVOLVED COMPONENTS: FE954K - AVM MICROCLIP PHYNOX STR.4MM STERILE - 52654989. FE955K - AVM MICROCLIP PHYNOX STR.5MM STERILE - 52654990.

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, WHEN THE PLIERS WERE TURNED TO PUT THE CLIPS IN POSITION, THE CLIPS FELL INTO THE SURGICAL FIELD. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT AVAILABLE. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00189 ((B)(4) + FE909K). 9610612-2021-00237 ((B)(4) + FE907K). INVOLVED COMPONENTS: FE954K - AVM MICROCLIP PHYNOX STR.4MM STERILE - 52654989. FE955K - AVM MICROCLIP PHYNOX STR.5MM STERILE - 52654990.