MI Z HANDLE ACET REAMER

Additional Manufacturer Narrative

INTERNAL COMPLAINT REFERENCE: (B)(4). ADDITIONAL INFORMATION AND CORRECTION: H11 (NON-REPORTABLE). H11: AFTER FURTHER ASSESSMENT OF THE INFORMATION GATHERED BY THE MANUFACTURER, IT WAS IDENTIFIED THAT THIS EVENT SHOULD BE RE-EVALUATED FOR MDR REPORTING. IT WAS CONFIRMED THAT REPORTED FRACTURED SECTION WAS OF THE INTERNAL JOINT THAT IS CONTAINED IN A COVER CASE, WHERE IT IS NOT POSSIBLE FOR PIECES TO FALL INTO THE SURGICAL SITE/INCISION, REQUIRING NO OR MINOR MEDICAL INTERVENTION. THE EVENT MAY RESULT IN A SHORT PROCEDURAL DELAY AND/OR REQUIRE THE USE OF A BACKUP DEVICE TO CONTINUE THE 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. THEREFORE, IT WAS DETERMINED THAT THIS CASE DOES NOT MEET THE THRESHOLD FOR REPORTING AND IS A NON-REPORTABLE EVENT. 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 THE COMPLETED INVESTIGATION.

Description of Event or Problem

IT WAS REPORTED THAT DURING AN ANTERIOR TOTAL HIP ARTHROPLASTY, ONE (1) MI Z HANDLE ACET REAMER SNAPPED OFF WHILE REAMING WHERE THE HANDLE HINGES. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED, OR IF THERE WAS ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

Additional Manufacturer Narrative

INTERNAL COMPLAINT REFERENCE: (B)(4). THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PRODUCT PROBLEM ASSOCIATED WITH A SMITH+NEPHEW DEVICE. THE REPORTED PROBLEM RELATES TO KNOWN RISKS WITH THE DEVICE ITSELF OR WITH ITS USE 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 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.