SL-PLUS INTEGR MIA STEM WITH TI/HA 6

Additional Manufacturer Narrative

H3, H6: THE COMPLAINT DEVICE INTENDED FOR USE IN TREATMENT WAS RETURNED FOR INVESTIGATION. A VISUAL EVALUATION OF THE DEVICE WAS CONDUCTED, AND IT WAS CONCLUDED THAT A BREACH THROUGH THE SEAL FROM THE DISTAL STEM TIP IS VISIBLE AT THE INNERMOST PEEL POUCH. ADDITIONALLY, SIGNS OF STEM MOVEMENT IN THE FORM OF SLIGHT SCRATCHES ON THE PEEL POUCH ARE VISIBLE. ADDITIONALLY, THE CARTON BOX DOES NOT LOOK PARTICULARLY DAMAGED. A REVIEW OF THE PRODUCTION DOCUMENTATION DID NOT DETECT ANY DEVIATION THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. THE REVIEW OF HISTORICAL COMPLAINTS FOR THE ALLEGED DEVICE REVEALED NO ADDITIONAL SIMILAR COMPLAINTS REPORTED FOR THE SAME BATCH, AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE SAME PRODUCT NUMBER OVER THE PAST 12 MONTHS WITH A SIMILAR FAILURE MODE. A REVIEW OF PAST CORRECTIVE ACTIONS WAS PERFORMED. NO FURTHER ESCALATION IS REQUIRED. A REVIEW OF THE RISK MANAGEMENT DOCUMENTATION VERIFIES THE FAILURE MODE, OCCURRENCE AND SEVERITY OF THE REPORTED ISSUE. ADDITIONALLY, THE PACKAGING SUPPLIER HAS PHYSICAL 1:1 PACKAGING SAMPLES APPROVED BY SMITH+NEPHEW. NO DEVIATION WAS DETECTED WHICH COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. THE PERFORMED INVESTIGATION DOES NOT LEAD TO AN ACCURATELY DETERMINED CAUSE. THERE IS NO INDICATION THAT THE REPORTED DEVICES FAILED TO MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. THERE IS NO NEED FOR FURTHER ACTIONS BECAUSE OF THE LIMITED INFORMATION PROVIDED. NEVERTHELESS, SMITH+NEPHEW WILL CONTINUE TO MONITOR THIS DEVICE FOR SIMILAR ISSUES. THE RETURNED DEVICE WILL BE DISCARDED.

Additional Manufacturer Narrative

INTERNAL COMPLAINT REFERENCE: (B)(4). 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, IT WAS FOUND THAT ONE (1) SL-PLUS INTEGR MIA STEM WITH TI/HA 6 HAD BROKEN THROUGH THE POUCH. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.