R3 OFFSET IMPACTOR

Additional Manufacturer Narrative

THE ASSOCIATED DEVICE WAS RETURNED AND EVALUATED. THE VISUAL INSPECTION REVEALED THAT THE DISTAL JOINT OF THE INTERIOR SHAFT IS FRACTURED, WITH THE DISTAL JOINT NOT RETURNED; THE ENTIRE DEVICE IS WORN FROM USE. A REVIEW OF THE PRODUCTION ORDER DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. A REVIEW OF COMPLAINT HISTORY BASED ON THE HISTORICAL DATA REVEALED SIMILAR EVENTS FOR THE LISTED BATCH, THIS FAILURE MODE WILL BE MONITORED FOR FUTURE COMPLAINTS FOR ANY NECESSARY CORRECTIVE ACTIONS. A REVIEW OF THE RISK MANAGEMENT FILE REVEALED THIS FAILURE MODE WAS PREVIOUSLY IDENTIFIED. THE ANTICIPATED RISK LEVEL IS STILL ADEQUATE. A HISTORICAL REVIEW CONCLUDED THAT A SIMILAR EVENT WAS PREVIOUSLY IDENTIFIED, AND ESCALATED ACTIONS WERE PERFORMED. IT HAS BEEN CONCLUDED THAT A POTENTIAL BREAKAGE COULD OCCUR IF USED AFTER THE EXPECTED LIFETIME OR EXCESSIVE FORCE IS APPLIED AS THIS DEVICE IS A REUSABLE INSTRUMENT AND IT IS EXPECTED TO WEAR OVER TIME. ALSO, THE FAILURE RATE OF THIS ISSUE IS WITHIN EXPECTED AND DOCUMENTED IN THE RISK FILE. THE BATCH NUMBER UNDER THIS COMPLAINT WAS MANUFACTURED BEFORE THESE ACTIONS WERE INITIATED. AT THIS TIME, WE HAVE NO EVIDENCE TO CONCLUDE THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. WE RECOMMEND THAT ALL REUSABLE INSTRUMENTS BE ROUTINELY INSPECTED FOR WEAR AND DAMAGE AND REPLACED AS NECESSARY. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED.

Additional Manufacturer Narrative

H10: 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.

Description of Event or Problem

IT WAS REPORTED THAT DURING A THR SURGERY, ONE (1) R3 OFFSET IMPACTOR BROKE UPON IMPACTION. THE PROCEDURE WAS COMPLETED WITH A SIMILAR S+N BACK UP PRODUCT, WITH NO DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.