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Patient 1
INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON MARCH 27, 2017. THE INVESTIGATION INCLUDED: METHODS: REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINTS HISTORY. RESULTS: THE FAILURE IS UNCONFIRMED. NO FAILURE ANALYSIS COULD BE PERFORMED AS THE PRODUCT WAS USED ON THE PATIENT DURING SURGERY, AND HAS NOT RETURNED. DHR REVIEW; THE NC/EVENT LOG AND BATCH RECORD WERE REVIEWED FOR ANY EVENTS RELATED TO THE LOTS OF THE COMPONENTS USED TO MANUFACTURE THE PRODUCT. ANY EVENTS OR NCS RELATED TO THE PARENT DISPERSION LOT OR THE REPORTED FINISHED GOODS LOT OF ANY TIME PERIOD WAS CONSIDERED. NO EVENTS OR NCS WERE FOUND FOR THIS LOT OR IT?S COMPONENT LOTS RELATED TO SKIN VISUAL APPEARANCE DEFECTS. COMPLAINTS HISTORY; A QUERY OF THE COMPLAINT DATABASE FOR THE TIMEFRAME OF 12 MONTHS ((B)(6) 2016-(B)(6) 2017) WAS PERFORMED USING THE INDIVIDUAL KEYWORDS: ?SKIN? AND ?THICK? OR ?THIN? OR ?UNEVEN?. NO OTHER COMPLAINTS WERE FOUND. CONCLUSION: THE ROOT CAUSE IS LIKELY USER MISINTERPRETATION OF THE REQUIRED THICKNESS RANGE FOR IDRT. BASED ON THE COMPLAINT BACKGROUND PROVIDED, REVIEW OF THE BATCH PRODUCTION RECORDS AND TRENDING, RISK ANALYSIS, AND THE COMPLAINT TYPE, IT CAN BE DETERMINED THAT THE DOCTOR NOTICED A VISUAL DIFFERENCE IN THE THICKNESS OF BOTH IDRT SHEETS WHEN COMPARED, BUT BASED ON THE MANUFACTURING PROCESS OF THE COMPLAINT LOT, NO FAILURE OCCURRED. COMPANY SOP DEFINES UNEVEN OR DESCENDING THICKNESS OF SPONGE FROM END TO END > 2:1 RATIO AS A DEFECT. MANUFACTURING PERFORMS 100% VISUAL INSPECTION OF ALL SPONGES PER SOP TO ENSURE EACH DEVICE MEETS THIS CRITERION. IF AN OUT OF SPECIFICATION THICKNESS WAS IDENTIFIED WITH ANY DEVICE DURING INSPECTION, THE IMPACTED DEVICE WOULD BE REJECTED. THICKNESS DOES INHERENTLY VARY FOR THE COATED SKIN PRODUCTS, BUT THE THICKNESS OF BOTH THE UNCOATED PRODUCT AND SILICONE IS CHECKED/DOCUMENTED IN PROCESS AND WAS WITHIN THE ACCEPTABLE RANGE. PRODUCTS ARE ONLY RELEASED BASED ON FINISHED GOODS RELEASE TESTING AND BATCH RECORD CRITERIA.