AS COLUMBUS REV FEM.SPACER POST.F7 5MM

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 NR567Z - AS COLUMBUS REV FEM.SPACER POST.F7 5MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE SPACER WAS NOT IMPLANTED. DARKENED COLOR OF THE IMPLANT HAD BEEN NOTED. AN ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. A BIGGER SIZE WAS USED INSTEAD AND FEMUR CUT ACCORDINGLY. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

Additional Manufacturer Narrative

INVESTIGATION RESULTS: VISUAL INSPECTION: IN THE CLOSED STERILE PACKAGES THE SCREW IS NO MORE FIXED IN THE SPACER AS INTENDED. AS A RESULT OF THIS, SMALLEST METAL PARTICLES COME LOOSE AND MAKE THE PRODUCT UNUSABLE. BATCH HISTORY REVIEW THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS (DHR) HAVE BEEN CHECKED FOR ALL LEADING DEVICE(S) LOT NUMBERS AND THE PRODUCTS FOUND TO BE ACCORDING TO OUR SPECIFICATION VALID AT THE TIME OF PRODUCTION. THERE ARE NO SIMILAR COMPLAINTS AGAINST THE SAME LOT NUMBER(S) WITH THIS ERROR PATTERN. THE REVIEW OF RISK ASSESSMENT REVEALED THAT THE OVERALL RISK LEVEL (SEVERITY 2(5) X PROBABILITY OF OCCURRENCE 1(5)) ACCORDING TO DIN EN ISO 14971 IS STILL ACCEPTABLE. EXPLANATION AND RATIONALE: THE IMPLANTS ITSELF WILL BE REVIEWED BY 100 PER CENT VISUAL INSPECTION WITHIN THE PRODUCTION- AND PACKAGING PROCESS. THEREFORE IT IS UNLIKELY THAT THE DEVICE HAS LEFT AAG IN SUCH CONDITION (SCREW NOT FIXED IN THE SPACER). IT COULD BE POSSIBLE THAT RELATIVE MOVEMENT (DURING TRANSPORTATION) COULD CAUSE THE SCREW TO LOOSEN AND UNSCREW. MOVEMENT IS ALWAYS POSSIBLE WHEN EVACUATING THE PACKAGING. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. BASED UPON THE INVESTIGATIONS RESULTS, A PRODUCT SAFETY CASE (PSC) HAS BEEN INITIATED.