CS/CSL/GERADSCHAFT-PLUS EXTRACT.SCREW M6

Description of Event or Problem

IT WAS REPORTED THAT, DURING A THR SURGERY, THE TIP OF THE CS/CSL/GERADSCHAFT-PLUS EXTRACT.SCREW M6 BROKE OFF AFTER REMOVING STEM. THE SURGERY WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME REPORTED DEVICE. NO INJURIES WERE REPORTED.

Additional Manufacturer Narrative

INTERNAL REFERENCE NUMBER: (B)(4).

Additional Manufacturer Narrative

IT WAS REPORTED THAT, DURING A TOTAL HIP REPLACEMENT SURGERY, THE TIP OF THE CS/CSL/GERADSCHAFT-PLUS EXTRACT.SCREW M6 BROKE OFF AFTER REMOVING STEM. THE SURGERY WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME REPORTED DEVICE. NO INJURIES WERE REPORTED. THE COMPLAINT DEVICE HAS NOT BEEN COMPLETELY RETURNED. A VISUAL EVALUATION OF THE RETURNED PART WAS CONDUCTED, AND IT WAS CONCLUDED THAT THERE IS A FRACTURE AT THE DISTAL PART OF THE DEVICE. THE TIP OF THE THREAD IS MISSING. 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 4 ADDITIONAL SIMILAR COMPLAINTS REPORTED FOR THE SAME BATCH, AND 6 ADDITIONAL SIMILAR COMPLAINTS FOR THE SAME PRODUCT NUMBER OVER THE PAST 12 MONTHS WITH SIMILAR FAILURE MODE. THE ROOT CAUSE IS ATTRIBUTED TO DESIGN CONSTRAINTS. 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. 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. REPEATED USE ALONG WITH CONSTANTLY APPLIED MECHANICAL FORCES ARE KNOWN FACTORS WHICH CONTRIBUTE TO THE DEVICE FRACTURE. 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. 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 RETAINED.