R3 OFFSET IMPACTOR

Description of Event or Problem

IT WAS REPORTED THAT, THE STRIKE PLATE ON THE BACK OF THE R3 OFFSET IMPACTOR BROKE. EVEN THOUGH THE BREAKAGE WAS NOTICED DURING THE CLEANING PROCESS, THE DEVICE WAS STILL USED FOR A THR SURGERY. 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). H11 EVENT DESCRIPTION AND IMPACT CODES UPDATED. H6: ADDITIONAL INFORMATION RECEIVED/REVIEWED BY THE MANUFACTURER HAS IDENTIFIED THAT THIS EVENT SHOULD BE RE-EVALUATED FOR MDR REPORTING. THE NEW INFORMATION STATES THAT THE PART OF THE DEVICE THAT BROKE OFF WAS THE STRIKE PLATE, THEREFORE, THE DEVICE DAMAGE DID NOT LEAD TO A DEATH OR SERIOUS INJURY, NOR WOULD IT BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF IT WERE TO RECUR. THIS EVENT 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.

Additional Manufacturer Narrative

INTERNAL COMPLAINT REFERENCE CASE-(B)(4). H3, H6: 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.

Description of Event or Problem

IT WAS REPORTED THAT, DURING A THR SURGERY, THE R3 OFFSET IMPACTOR BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.