R3 OFFSET IMPACTOR

Description of Event or Problem

IT WAS REPORTED THAT, DURING A THA SURGERY, THE HINGE OF ONE (1) R3 OFFSET IMPACTOR SNAPPED DURING THE CUP PLACEMENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

INTERNAL COMPLAINT REFERENCE: (B)(4). ADDITIONAL INFORMATION: H11: THE INFORMATION RECEIVED BY THE MANUFACTURER HAS BEEN RE-EVALUATED FOR MDR REPORTING AND IT WAS DETERMINED THAT THIS CASE DOES NOT MEET THE THRESHOLD FOR REPORTING AND IS A NON-REPORTABLE EVENT. THE FRACTURE OCCURRED IN THE PROXIMAL END. IF FURTHER DETAILS ARE PROVIDED CONFIRMING THE OCCURRENCE OF A REPORTABLE EVENT, OUR FILES WILL BE UPDATED ACCORDINGLY, AND A FURTHER REPORT SUBMITTED OUTLINING BOTH THE EVENT DETAILS AND OUR INVESTIGATIONS PERFORMED. WHILE THIS EVENT IS NO LONGER CONSIDERED REPORTABLE, THIS REPORT IS BEING SUBMITTED AS A COURTESY TO PROVIDE UPDATED INVESTIGATION RESULTS BASED ON THE RETURN AND EVALUATION OF THE COMPLAINT DEVICE SUBSEQUENT TO THE SUBMISSION OF OUR PREVIOUS SUPPLEMENTAL REPORT. THE ASSOCIATED DEVICE WAS RETURNED AND EVALUATED. THE VISUAL INSPECTION REVEALED THAT THE DEVICE RETURNED HEAVILY WORN FROM USE, WITH THE PROXIMAL INTERNAL SHAFT FRACTURED AND LOOSE ON 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 IDENTIFIED AND IS BEING ADDRESSED THOUGH OUR INTERNAL QUALITY PROCESS. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS 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.