CONQUEST FN SCREWDRIVER

Description of Event or Problem

IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, WHEN TRYING TO INSERT A THIRD SCREW INTO THE PATIENT, IT WAS NOTICED THAT THE CLIP THAT RETAINS THE SCREW AT THE END OF ONE (1) CONQUEST FN SCREWDRIVER WAS MISSING. IT APPEARS THAT THE CLIP FELL OFF AT SOME POINT DURING THE PROCEDURE, RESULTING IN THE SCREWDRIVER NOT BEING ABLE TO INSERT THE SCREW CORRECTLY INTO THE PLATE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A HEAVY NEEDLE DRIVER TO HOLD THE SCREW TO THE DRIVER IN AN EXTENDED POSITION IN ORDER TO COMPLETE THE SURGERY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

Additional Manufacturer Narrative

INTERNAL COMPLAINT REFERENCE: (B)(). 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 INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.