PRIMARY ACETABULAR REAMER INSTR SET

Additional Manufacturer Narrative

INTERNAL COMPLAINT REFERENCE: (B)(4). 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 INHERENT DEVICE AND/OR PROCEDURAL RISKS 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 CONSERVATIVELY 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, AT THE TIME OF STARTING THE ACETABULAR REAMING, TWENTY-ONE (21) REAMER DOMES (SIZES 38 MM AND FROM 40 MM TO 60 MM) FROM ONE (1) PRIMARY ACETABULAR REAMER INSTR SET HAD NO SHARP EDGES. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30MIN, WITH THE SAME DEVICES USING A GUIDE AND OTHER INSTRUMENTS TO FACILITATE THE ACETABULAR REAMING. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.