DBL OFFSET BROACH HDLE LT

Additional Manufacturer Narrative

H11: ADDITIONAL INFORMATION REVIEWED BY THE MANUFACTURER HAS IDENTIFIED THAT THIS EVENT SHOULD BE RE-EVALUATED FOR MDR REPORTING. THE NEW INFORMATION STATES THAT THE DOWEL PIN IS LOOSE ON THE LINKAGE AND THE ENTIRE DEVICE IS HEAVILY WORN FROM USE, THEREFORE, THE EVENT MAY CAUSE MINOR OR TEMPORARY INJURY REQUIRING NO OR MINOR MEDICAL INTERVENTION. EVENT MAY RESULT IN A SHORT PROCEDURAL DELAY AND/OR REQUIRE USE OF A BACKUP DEVICE TO CONTINUE PROCEDURE. THIS EVENT IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY AND IS CONSIDERED NOT REPORTABLE PURSUANT TO APPLICABLE REGULATIONS.. IF ADDITIONAL DETAILS CONFIRM THE OCCURRENCE OF A REPORTABLE EVENT, WE WILL UPDATE OUR RECORDS ACCORDINGLY AND SUBMIT A SUBSEQUENT REPORT DETAILING BOTH THE EVENT AND OUR COMPLETED INVESTIGATIONS. H3, H6: THE ASSOCIATED DEVICE WAS RETURNED AND EVALUATED. THE VISUAL INSPECTION REVEALED THE DOWEL PIN LOOSE ON THE LINKAGE, THE ENTIRE DEVICE IS HEAVILY WORN FROM USE. A DEVICE RECORD REVIEW WAS NOT PERFORMED BECAUSE THE INSTRUMENT HAD BEEN IN DISTRIBUTION FOR SEVERAL YEARS, AND THE AVAILABLE INFORMATION INDICATES THAT A MANUFACTURING DEFICIENCY CAN BE RULED OUT AS A CONTRIBUTING FACTOR. 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 THERE ARE NO PRIOR ACTIONS RELATED TO THIS PRODUCT AND EVENT. 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. AT THIS TIME, WE HAVE NO EVIDENCE TO CONCLUDE THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. 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. CORRECTED DATA: H6 (MEDICAL DEVICE PROBLEM CODE).

Description of Event or Problem

IT WAS REPORTED THAT, DURING A THA SURGERY, ONE (1) DBL OFFSET BROACH HDLE LT BROKE. 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).