CS/CSL/GERADSCHAFT-PLUS EXTRACT.SCREW M6

Description of Event or Problem

IT WAS REPORTED THAT, DURING THE REVISION, THE TIP OF THE CS/CSL/GERADSCHAFT-PLUS EXTRACT SCREW M6 BROKE WHILE EXPLANTING THE FEMORAL COMPONENT, IT WAS COMPLETELY REMOVED. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

Additional Manufacturer Narrative

INTERNAL COMPLAINT REFERENCE CASE-(B)(4). THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PRODUCT PROBLEM ASSOCIATED WITH A SMITH+NEPHEW DEVICE. THE REPORTED PROBLEM RELATES TO KNOWN INHERENT DEVICE AND/OR PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED. SMITH+NEPHEW HAS NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON OUR REVIEW OF ALL CURRENTLY AVAILABLE INFORMATION, WE ARE UNABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, AS THE USE OF OUR PRODUCT CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OR CONTRIBUTORY FACTOR TO THE REPORTED ISSUE, WE ARE CONSERVATIVELY SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D4, H6, H10. H3, H6: IT WAS REPORTED THAT, DURING A TOTAL HIP REPLACEMENT REVISION, THE TIP OF THE CS/CSL/GERADSCHAFT-PLUS EXTRACT.SCREW M6 BROKE WHILE EXPLANTING THE FEMORAL COMPONENT, IT WAS COMPLETELY REMOVED. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE INTENDED FOR USE IN TREATMENT WAS NOT RETURNED FOR INVESTIGATION. A PRODUCT EVALUATION WAS NOT POSSIBLE. NO BATCH NUMBER WAS COMMUNICATED SO THE PRODUCTION HISTORY REVIEW WAS NOT POSSIBLE. DUE TO AN UNKNOWN BATCH NUMBER, THE REVIEW OF HISTORICAL COMPLAINTS WAS PERFORMED ON PRODUCT NUMBER BASIS ONLY, REVEALING 4 ADDITIONAL COMPLAINTS OVER THE PAST 12 MONTHS WITH SIMILAR FAILURE MODE. DUE TO INSUFFICIENT INFORMATION IT IS NOT POSSIBLE TO PERFORM A REVIEW OF PAST CORRECTIVE ACTIONS. A REVIEW OF THE RISK MANAGEMENT DOCUMENTATION VERIFIES THE FAILURE MODE, OCCURRENCE AND SEVERITY OF THE REPORTED ISSUE. THE PERFORMED INVESTIGATION DOES NOT LEAD TO AN ACCURATELY DETERMINED CAUSE. BASED ON THE AVAILABLE INFORMATION IT IS NOT POSSIBLE TO INVESTIGATE WHETHER THE REPORTED DEVICE MET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. DUE TO INSUFFICIENT INFORMATION, IT IS NOT POSSIBLE TO INDICATE FACTORS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. ACCORDING TO DOCUMENT "PROCESSING (CLEANING, DISINFECTION AND STERILIZATION) OF INSTRUMENTS FROM SMITH+NEPHEW ORTHOPAEDICS AG" (LIT. N°03389-EN 1363 V3 11/19), ALL DEVICES MUST BE INSPECTED AND CONTROLLED FOR PROPER FUNCTIONING AFTER CLEANING/DISINFECTION. THERE IS NO NEED FOR FURTHER ACTIONS BECAUSE OF THE LIMITED INFORMATION PROVIDED. NEVERTHELESS, SMITH + NEPHEW WILL CONTINUE TO MONITOR THIS DEVICE FOR SIMILAR ISSUES. THIS COMPLAINT WILL BE REOPENED SHOULD ADDITIONAL INFORMATION OR THE DEVICE BE RECEIVED.