XTENDOBUTTON FIXATION DEVICE

Additional Manufacturer Narrative

H10: 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 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 SET UP, THE XTENDOBUTTON FIXATION DEVICE INNER PACKAGING BAG HAD LEAKED AIR, THE STERILE BARRIER WAS COMPROMISED. THERE WAS A BACK-UP DEVICE AVAILABLE, AND THERE WAS A DELAY OF LESS THAN 30 MINUTES. THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

INTERNAL COMPLAINT REFERENCE (B)(4). H11 H3, H6: THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL EVALUATION SHOWED THE XTENDOBUTTON WAS RETURNED IN ORIGINAL PACKAGING WITH THE BATCH NUMBER OF THE COMPLAINT ON THE LABEL. THE OUTER POUCH HAS BEEN TORN OPEN. THE INNER POUCH HAS BEEN CUT OPEN ON THE NON-CHEVRON END. THE XTENDOBUTTON HAS NO VISIBLE DEFECT. AN IMAGE EVALUATION WAS PERFORMED AND FOUND THE PACKAGING OF THE DEVICE OPENED AND IT APPEARS TO BE CUT IN HALF. THE LABEL WITH THE PRODUCT'S LOT NUMBER IS ON THE PACKAGING. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND NO 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 PACKAGING SEQUENCE OF ENDOBUTTON DIRECT, FOUND THAT THE PACKAGING ASSOCIATE MUST VERIFY POUCH IS FREE OF PIN HOLES, CUTS, PARTICULATES AND SEAL DEFECTS. INSERT THE PRODUCT SLOWLY TO MINIMIZE POUCH SURFACE DEFECTS. INSPECT S&N SEALS FOR CREASES OR WRINKLES ON THE SEAL. REJECT POUCH IF THESE DEFECTS ARE FOUND. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED SINCE FINDINGS CANNOT LEAD TO A CLEAR CAUSE OF THE REPORTED EVENT. FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE UNINTENDED IMPACT EVENT INCONSISTENT WITH NORMAL USE OR IMPROPER HANDLING DURING STORAGE OR TRANSPORTATION. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

Additional Manufacturer Narrative

H2: CORRECTED INFORMATION IN H6 (INVESTIGATION FINDINGS & COMPONENT CODE). H3, H6: THE REPORTED DEVICE WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION. HOWEVER, AN IMAGE EVALUATION WAS PERFORMED AND FOUND THE PACKAGING OF THE DEVICE OPENED AND IT APPEARS TO BE CUT IN HALF. THE LABEL WITH THE PRODUCT'S LOT NUMBER IS ON THE PACKAGING. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND NO 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 PACKAGING SEQUENCE OF ENDOBUTTON DIRECT, FOUND THAT THE PACKAGING ASSOCIATE MUST VERIFY POUCH IS FREE OF PIN HOLES, CUTS, PARTICULATES AND SEAL DEFECTS. INSERT THE PRODUCT SLOWLY TO MINIMIZE POUCH SURFACE DEFECTS. INSPECT S&N SEALS FOR CREASES OR WRINKLES ON THE SEAL. REJECT POUCH IF THESE DEFECTS ARE FOUND. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED SINCE FINDINGS CANNOT LEAD TO A CLEAR CAUSE OF THE REPORTED EVENT. FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE UNINTENDED IMPACT EVENT INCONSISTENT WITH NORMAL USE OR IMPROPER HANDLING DURING STORAGE OR TRANSPORTATION. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.