CS/CSL/GERADSCHAFT-PLUS EXTRACT.SCREW M6

Additional Manufacturer Narrative

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.

Description of Event or Problem

IT WAS REPORTED THAT, DURING A THR, THE TIP OF THE CS/CSL/GERADSCHAFT-PLUS EXTRACT. SCREW M6 SNAPPED DURING POLARSTEM REMOVAL. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

Additional Manufacturer Narrative

G4. LOT NUMBER: UPDATED.

Additional Manufacturer Narrative

H3, H6: IT WAS REPORTED THAT, DURING A TOTAL HIP REPLACEMENT (THR), THE TIP OF THE CS/CSL/GERADSCHAFT-PLUS EXTRACT.SCREW M6 SNAPPED DURING POLARSTEM REMOVAL. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM. THE DEVICE, INTENDED FOR USE IN TREATMENT, WAS RETURNED FOR EVALUATION. UPON VISUAL INSPECTION, THE REPORTED FAILURE CAN BE CONFIRMED AND PART OF THE DISTAL THREAD IS FRACTURED OFF. A REVIEW OF THE PRODUCT DOCUMENTATION DID NOT DETECT ANY DEVIATION THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. A REVIEW OF PAST CORRECTIVE ACTIONS WAS PERFORMED. NO FURTHER ESCALATION IS REQUIRED. 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 4 ADDITIONAL SIMILAR COMPLAINTS FOR THE SAME PRODUCT NUMBER OVER THE PAST 12 MONTHS WITH SIMILAR A FAILURE MODE. BASED ON THE AVAILABLE INFORMATION AND THE PERFORMED INVESTIGATION, THE REPORTED FAILURE MODE COULD BE CONFIRMED. CONSIDERING THE PERFORMED VISUAL INSPECTION, THIS DEVICE FAILURE MAY ARISE FROM A ¿WEAR AND TEAR ISSUE¿. REGULAR WEAR AND TEAR ARE KNOWN TO CONTRIBUTE TO THE REPORTED EVENT. BUT THE EXACT ROOT CAUSE OF THE REPORTED EVENT REMAINS UNDETERMINED. THIS INVESTIGATION IS CONSIDERED CLOSED. THE NEED FOR FURTHER ACTIONS IS NOT INDICATED. SMITH AND NEPHEW WILL CONTINUE TO MONITOR THIS DEVICE FOR SIMILAR ISSUES. THE RETURNED COMPLAINT SAMPLE WILL BE SCRAPPED.