R3 OFFSET IMPACTOR

Description of Event or Problem

IT WAS REPORTED THAT DURING A THR SURGERY, THE IMPACTOR PLATE OF THE R3 OFFSET IMPACTOR BROKE OFF. NO PIECES FELL IN THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

Additional Manufacturer Narrative

H11: INTERNAL COMPLAINT REFERENCE: (B)(4).

Additional Manufacturer Narrative

THE ASSOCIATED DEVICE WAS RETURNED AND EVALUATED. A VISUAL INSPECTION OF THE RETURNED DEVICE FINDS THE DEVICE RETURNED HEAVILY WORN FROM USE, WITH THE STRIKE PLATE WELD FRACTURED AND THE STRIKE PLATE RETURNED OFF THE DEVICE. 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 REVEALED SIMILAR EVENTS FOR THE LISTED PART NUMBER OVER THE PREVIOUS 12 MONTHS, BUT NO SIMILAR EVENTS FOR THE BATCH BASED ON THE HISTORICAL DATA, 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. AT THIS TIME, WE HAVE NO EVIDENCE TO CONCLUDE THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. 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. WE RECOMMEND THAT ALL REUSABLE INSTRUMENTS BE ROUTINELY INSPECTED FOR WEAR AND DAMAGE AND REPLACED AS NECESSARY. THIS ISSUE WAS PREVIOUSLY IDENTIFIED AND WAS ADDRESSED THROUGH QUALITY PROCESS. 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.