R3 OFFSET IMPACTOR

Additional Manufacturer Narrative

H3, H6: THE ASSOCIATED DEVICE WAS RETURNED AND EVALUATED. THE VISUAL INSPECTION REVEALED THAT THE DISTAL WELD IS FRACTURED AND THE DISTAL LINK SEPARATE FROM THE DEVICE. ALSO, THE DEVICE IS HEAVILY 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 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 OVERTIME. 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. 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.

Description of Event or Problem

IT WAS REPORTED THAT DURING A THR SURGERY THE LITTLE SCREW THAT GOES INTO THE DISTAL TIP OF ONE (1) R3 OFFSET IMPACTOR BROKE WHEN TRYING TO PUT ON THE R3 TRIAL. NO PIECES FELL INSIDE THE WOUND. NO PATIENT WAS HARMED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

Additional Manufacturer Narrative

INTERNAL COMPLAINT REFERENCE: (B)(4). ADDITIONAL INFORMATION: B5: DESCRIBE EVENT OR PROBLEM; E1: NAME PREFIX/TITLE.

Additional Manufacturer Narrative

INTERNAL COMPLAINT REFERENCE: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT DURING A THR SURGERY THE LITTLE SCREW THAT GOES INTO THE DISTAL TIP OF ONE (1) R3 OFFSET IMPACTOR BROKE WHEN TRYING TO PUT ON THE R3 TRIAL. NO PIECES FELL INSIDE THE WOUND. NO PATIENT WAS HARMED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.