BIOINDUCTIVE IMPLANT W ARTHRO DEL MED

Additional Manufacturer Narrative

H11: INTERNAL COMPLAINT REFERENCE (B)(4). 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.

Description of Event or Problem

IT WAS REPORTED THAT DURING SURGERY, AFTER THE IMPLANTATION OF ONE (1) REGENETEN BIOINDUCTIVE IMPLANT AND TENDON ANCHORS, WHEN THE DELIVERY INSTRUMENT OF THE REGENETEN IMPLANT WAS BEING REMOVED FROM THE BODY, THE IMPLANT SHEET WAS TORN. THE DELIVERY INSTRUMENT AND THE TORN SHEET WAS REMOVED FROM THE BODY. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

Additional Manufacturer Narrative

H11 H3, H6 THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION REVEALED THAT IT IS NOT IN ITS ORIGINAL PACKAGING. THE INSERTION DEVICE WAS RETURNED WITH ALMOST HALF OF THE FRACTURED BIOINDUCTIVE IMPLANT RETURNED, PARTIALLY UNFURLED, ON THE INSERTION DEVICE. THE OTHER PIECE OF THE IMPLANT WAS NOT RETURNED. A FUNCTIONAL EVALUATION WAS PERFORMED ON THE RETURNED DEVICE AND FOUND THAT IT CYCLES AS DESIGNED. AN ASSESSMENT OF MATERIAL CHARACTERISTICS FOUND THAT BASED ON THE CONDITION OF THE PRODUCT MATERIAL FOUND DURING VISUAL INSPECTION, ADDITIONAL MATERIAL TESTING IS NOT REQUIRED. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTED EVENTS. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE AND/OR HARM WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. A REVIEW OF THE MATERIAL SPECIFICATIONS FOUND THE DIMENSIONS, MATERIAL CHARACTERISTICS AND REQUIRED TESTS. A DEFINITIVE ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. FACTORS THAT COULD HAVE CONTRIBUTED TO THE FAILURE INCLUDE AN APPLICATION OF UNINTENDED INAPPROPRIATE OR EXCESSIVE FORCE TO THE DEVICE, ATTEMPTED CORRECTION OF A DAMAGED DEVICE, OR AN IMPACT EVENT INCONSISTENT WITH NORMAL USE. BASED ON THIS INVESTIGATION, THERE IS NO EVIDENCE TO SUGGEST A DESIGN, MATERIAL OR MANUFACTURING ISSUE. THEREFORE, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.