R3 OFFSET IMPACTOR

Additional Manufacturer Narrative

INTERNAL COMPLAINT REFERENCE: (B)(4). THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PATIENT COMPLICATION RELATED TO A PRODUCT PROBLEM WITH A SMITH+NEPHEW DEVICE. THE REPORTED ISSUE(S) RELATE 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, ONE (1) R3 OFFSET IMPACTOR FRACTURED DURING IMPACTION, PIECES FELT INTO THE PATIENT'S WOUND AND THEY WERE PARTIALLY REMOVED. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.