CS/CSL/GERADSCHAFT-PLUS EXTRACT.SCREW M6

Description of Event or Problem

IT WAS REPORTED THAT, DURING A THR, ONE (1) CS/CSL/GERADSCHAFT-PLUS EXTRACT. SCREW M6 WAS THREADED INTO ONE (1) POLARSTEM EXTRACTOR BLOCK TO REMOVE THE FEMORAL COMPONENT FROM THE PATIENT'S FEMUR, BUT AFTER SEVERAL IMPACT, THE THREADED PORTION OF THE EXTRACTION SCREW BROKE OFF, RENDERING THE EXTRACTION BLOCK USELESS. THERE WAS NO BREAKAGE INTO PIECES INSIDE THE PATIENT. IT IS UNKNOWN HOW WAS THE PROCEDURE COMPLETED. NO DELAY NOR INJURY WERE REPORTED AS A CONSEQUENCE OF THIS ISSUE.

Additional Manufacturer Narrative

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 INVESTIGATIVE FINDINGS OR INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.

Additional Manufacturer Narrative

H3, H6: THE COMPLAINT DEVICE USED IN TREATMENT WAS RETURNED FOR INVESTIGATION. A VISUAL EVALUATION OF THE DEVICE WAS CONDUCTED, AND IT WAS CONCLUDED THAT A DISTAL THREAD FRAGMENT OF THE M6 EXTRACTION SCREW HAS BROKEN-OFF AND IS STUCK IN THE EXTRACTOR BLOCK. 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. A REVIEW OF PAST ESCALATION ACTIONS FOUND NO EVENTS APPLICABLE TO THIS COMPLAINT. A REVIEW OF THE RISK MANAGEMENT DOCUMENTATION VERIFIES THE FAILURE MODE, OCCURRENCE AND SEVERITY OF THE REPORTED ISSUE. THERE IS NO INDICATION THAT THE REPORTED DEVICE FAILED TO MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. THE ROOT CAUSE OF THE EVENT CAN BE ATTRIBUTED TO A COMPONENT FAILURE. 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. THEREFORE, ALL REUSABLE INSTRUMENTS MUST BE ROUTINELY INSPECTED FOR SIGNS OF WEAR AND DAMAGE AFTER REPROCESSING. ANY INSTRUMENTS FOUND TO BE DAMAGED SHOULD BE REPLACED AS NECESSARY TO ENSURE THEIR PROPER FUNCTIONING AND TO MAINTAIN PATIENT SAFETY. THIS GUIDANCE IS PROVIDED BY SMITH & NEPHEW ORTHOPAEDICS AG (REFERENCE: LIT. N°03389-EN 1363 V4 01/25). 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. ADDITIONAL INFORMATION: D9.

Additional Manufacturer Narrative

THE DEVICE, INTENDED FOR USE IN TREATMENT, WAS NOT RETURNED. HOWEVER, PHOTOS WERE PROVIDED FROM THE COMPLAINANT AND THEREFORE THE PRODUCT EVALUATION WAS PERFORMED BASED ON THE PROVIDED PHOTOS. UPON VISUAL INSPECTION OF THE PROVIDED PHOTOS, THE COMPLAINT CAN BE CONFIRMED AND THE DISTAL THREAD OF THE COMPLAINT DEVICE IS FRACTURED. A REVIEW OF THE PRODUCT DOCUMENTATION DID NOT DETECT ANY DEVIATION THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. A REVIEW OF THE RISK MANAGEMENT DOCUMENTATION VERIFIES THE FAILURE MODE, OCCURRENCE AND SEVERITY OF THE REPORTED ISSUE. THE REVIEW OF HISTORICAL COMPLAINTS FOR THE ALLEGED DEVICE REVEALED NO ADDITIONAL SIMILAR COMPLAINTS REPORTED FOR THE SAME BATCH, AND THREE ADDITIONAL SIMILAR COMPLAINTS FOR THE SAME PRODUCT NUMBER OVER THE PAST 12 MONTHS WITH SIMILAR A FAILURE MODE. A REVIEW OF PAST CORRECTIVE ACTIONS WAS PERFORMED. NO FURTHER ESCALATION IS REQUIRED. BASED ON THE AVAILABLE INFORMATION AND THE PERFORMED INVESTIGATION, THE COMPLAINT CAN BE CONFIRMED. THE ROOT CAUSE OF THE REPORTED EVENT REMAINS THEREFORE UNDETERMINED. 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. THEREFORE, ALL REUSABLE INSTRUMENTS MUST BE ROUTINELY INSPECTED FOR SIGNS OF WEAR AND DAMAGE AFTER REPROCESSING. ANY INSTRUMENTS FOUND TO BE DAMAGED SHOULD BE REPLACED AS NECESSARY TO ENSURE THEIR PROPER FUNCTIONING AND TO MAINTAIN PATIENT SAFETY. THIS GUIDANCE IS PROVIDED BY SMITH & NEPHEW ORTHOPAEDICS AG (REFERENCE: LIT. N°03389-EN 1363 V3 11/19). THIS COMPLAINT CASE IS CONSIDERED AS CLOSED. THE NEED FOR FURTHER ACTIONS IS NOT INDICATED. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. SMITH AND NEPHEW WILL CONTINUE TO MONITOR THIS DEVICE FOR SIMILAR ISSUES.