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

Additional Manufacturer Narrative

H11: THIS COMPLAINT HAS BEEN REASSESSED BASED ON ADDITIONAL INFORMATION GATHERED BY THE MANUFACTURER. IT WAS DETERMINED THAT THIS EVENT DOES NOT FULFILL REPORTING REQUIREMENTS PER 21 CFR §803. BASED ON THE VISUAL ANALYSIS FINDINGS, THE PART OF THE DEVICE THAT BROKE OFF CORRESPONDS TO THE PROXIMAL END OF THE ADAPTER, WHICH DOES NOT COMES IN CONTACT WITH THE PATIENT. THERE IS NO CHANCE OF ANY BROKEN PIECES FALLING INTO THE PATIENT'S INCISION, AS THE BROKEN PART IS CONNECTED TO THE KNOCKING PLATE, WHICH WILL RETAIN THE BROKEN PIECE IN THE EVENT OF A BREAKAGE AS INITIALLY REPORTED.

Additional Manufacturer Narrative

RESULTS OF INVESTIGATION: IT WAS REPORTED THAT, DURING A TOTAL HIP REPLACEMENT, THE CONNECTION SECTION ON A PLUS SL MIA DBL OFFSET ADAPT. LT 60/25MM WAS FOUND TO BE BROKEN. NO PATIENT HARM HAS BEEN REPORTED. THE DEVICE USED IN TREATMENT WAS NOT RETURNED FOR INVESTIGATION. A PRODUCT EVALUATION WAS NOT POSSIBLE. NO BATCH NUMBER WAS COMMUNICATED SO THE DOCUMENT 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 SPECULATE ABOUT FACTORS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. ACCORDING TO DOCUMENT "PROCESSING (CLEANING, DISINFECTION AND STERILIZATION) OF INSTRUMENTS FROM SMITH & NEPHEW ORTHOPAEDICS AG", 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.

Additional Manufacturer Narrative

H10: INTERNAL COMPLAINT REFERENCE: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT, DURING A THR, THE CONNECTION SECTION ON A PLUS SL MIA DBL OFFSET ADAPT. LT 60/25MM WAS FOUND TO BE BROKEN. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. NO PATIENT HARM HAS BEEN REPORTED.