PLUS SL MIA DBL OFFSET ADAPT. LT 60/25MM

Additional Manufacturer Narrative

INTERNAL COMPLAINT REFERENCE: (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.

Description of Event or Problem

IT WAS REPORTED THAT DURING THR SURGERY, THE CONNECTION OF THE PLUS SL MIA DBL OFFSET ADAPT. LT 60/25MM BROKE WHILE IMPACTING. CARE WAS TAKEN TO ENSURE THAT NO ADDITIONAL FRAGMENTS WERE PRESENT. X-RAYS WERE ALWAYS USED DURING SURGERY TO ENSURE THAT NO ADDITIONAL FRAGMENTS WERE PRESENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

Additional Manufacturer Narrative

IT WAS REPORTED THAT DURING TOTAL HIP REPLACEMENT SURGERY, THE CONNECTION OF THE PLUS SL MIA DBL OFFSET ADAPT. LT 60/25MM BROKE WHILE IMPACTING. CARE WAS TAKEN TO ENSURE THAT NO ADDITIONAL FRAGMENTS WERE PRESENT. X-RAYS WERE ALWAYS USED DURING SURGERY TO ENSURE THAT NO ADDITIONAL FRAGMENTS WERE PRESENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH+NEPHEW BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE. THE COMPLAINT DEVICE HAS NOT BEEN COMPLETELY RETURNED. A VISUAL EVALUATION OF THE RETURNED PART WAS CONDUCTED, AND IT WAS CONCLUDED THAT THE CLUTCH IS FRACTURED BUT THE FRAGMENT WAS NOT RETURNED. A REVIEW OF THE PRODUCTION DOCUMENTATION DID NOT DETECT ANY DEVIATION THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. THE REVIEW OF HISTORICAL COMPLAINTS FOR THE ALLEGED DEVICE REVEALED NO ADDITIONAL SIMILAR COMPLAINTS REPORTED FOR THE SAME BATCH, AND 5 ADDITIONAL SIMILAR COMPLAINTS FOR THE SAME PRODUCT NUMBER OVER THE PAST 12 MONTHS WITH SIMILAR FAILURE MODE. A REVIEW OF THE RISK MANAGEMENT DOCUMENTATION VERIFIES THE FAILURE MODE, OCCURRENCE AND SEVERITY OF THE REPORTED ISSUE. PREVIOUS INVESTIGATIONS REVEALED THAT UNDER SPECIFIC CIRCUMSTANCES, THE CLUTCH OF THE DEVICE MAY FRACTURE WHILE HITTING. THE ROOT CAUSE IS ATTRIBUTED TO A DESIGN ISSUE. A NEW DESIGN OF THE DEVICE HAS BEEN RELEASED IN ORDER TO REDUCE THE REOCCURRENCE OF THIS ISSUE. THIS VERSION OF THE DEVICE WILL BE MONITORED FOR SIMILAR ISSUES. THE PERFORMANCE OF THE DEVICE IS NONETHELESS WITHIN THE RISKS, WHICH ARE ANTICIPATED IN THE RISK MANAGEMENT DOCUMENTATION OF THE PRODUCT. NO FURTHER ESCALATION IS REQUIRED. PLEASE NOTE THAT 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. FURTHERMORE, IN THE INSTRUMENT SETS OF SMITH & NEPHEW ORTHOPAEDICS AG, THERE IS ALWAYS AT LEAST ONE BACKUP RASP ADAPTER AVAILABLE. THERE IS NO INDICATION THAT THE REPORTED DEVICE FAILED TO MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. THE NEED FOR FURTHER ACTIONS IS NOT INDICATED. NEVERTHELESS, SMITH+NEPHEW WILL CONTINUE TO MONITOR THIS DEVICE FOR SIMILAR ISSUES. THE RETURNED DEVICE WILL BE DISCARDED.