DISP FIRSTPASS STR PASSR SELF

Description of Event or Problem

IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY ROTATOR CUFF PROCEDURE, WHEN PASSING THE FIRST STITCH OF THE FIRSTPASS SUTURE PASSER, THE NEEDLE PIERCED THE TISSUE, BROKE THE SUTURE, AND BECOME STUCK WITH THE NEEDLE STICKING OUT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A COMPETITOR DEVICE. THE PATIENT WAS STABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

Additional Manufacturer Narrative

H11 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.