CS/CSL/GERADSCHAFT-PLUS EXTRACT.SCREW M6

Description of Event or Problem

IT WAS REPORTED THAT, DURING A THR SURGERY, THE CS/CSL/GERADSCHAFT-PLUS EXTRACT. SCREW M6 BROKE WHILE ATTEMPTING TO EXTRACT THE IMPLANTED POLAR STEM. THE BROKEN PIECE WAS FULLY RECOVERED. THE PROCEDURE WAS RESUMED, AFTER A 5-MINUTE DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

Additional Manufacturer Narrative

H11: INTERNAL COMPLAINT REFERENCE: (B)(4). H3, H6: 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

THE COMPLAINT DEVICE INTENDED FOR USE IN TREATMENT WAS RETURNED FOR INVESTIGATION. A VISUAL EVALUATION OF THE DEVICE WAS CONDUCTED, AND IT WAS CONCLUDED THAT THE DEVICE DISTAL THREAD IS DEFORMED. 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 3 ADDITIONAL SIMILAR COMPLAINTS FOR THE SAME PRODUCT NUMBER OVER THE PAST 12 MONTHS WITH SIMILAR A FAILURE MODE. THE ROOT CAUSE IS ATTRIBUTED TO A WEAR AND TEAR ISSUE. ACCORDING TO DOCUMENT "PROCESSING (CLEANING, DISINFECTION AND STERILIZATION) OF INSTRUMENTS FROM SMITH & NEPHEW ORTHOPAEDICS AG" (LIT. N°03389-EN 1363 V4 01/25), ALL INSTRUMENTS MUST BE INSPECTED AND CONTROLLED FOR PROPER FUNCTIONING AFTER CLEANING/DISINFECTION. ANY INSTRUMENTS FOUND TO BE DAMAGED SHOULD BE REPLACED AS NECESSARY TO ENSURE THEIR PROPER FUNCTIONING AND TO MAINTAIN PATIENT SAFETY. THE PERFORMANCE OF THE DEVICE IS WITHIN THE RISKS, WHICH ARE ANTICIPATED IN THE RISK MANAGEMENT DOCUMENTATION OF THE PRODUCT. NO FURTHER ESCALATION IS REQUIRED. THERE IS NO INDICATION THAT THE REPORTED DEVICE FAILED TO MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. THIS DEVICE IS A REUSABLE INSTRUMENT THAT CAN BE EXPOSED TO NUMEROUS SURGERIES. DAMAGE FROM PROLONGED USE, MISUSE OR ROUGH HANDLING ARE LIKELY POTENTIAL FACTORS THAT COULD CONTRIBUTE TO THE REPORTED EVENT. FURTHERMORE, THE DAMAGE FOUND IN THE VISUAL INSPECTION INDICATES THAT THE DEVICE WILL NOT FUNCTION AS INTENDED. THE RETURNED DEVICE WILL BE DISCARDED.