SURG PATXRAY 1/2X1/2-200

Additional Manufacturer Narrative

SAMPLE WAS RECEIVED FOR EVALUATION. PRODUCT WAS RETURNED FOR FAILURE ANALYSIS AND THE COMPLAINT COULD BE VERIFIED THROUGH FAILURE ANALYSIS. PER THE FAILURE ANALYST, PATTIE SAMPLE WAS RECEIVED AND MISCOUNT OF 9 OF (B)(4) PATTIES WAS CONFIRMED. APPLICABLE DHRS WERE REVIEWED AND NO ANOMALIES WERE FOUND. THE PATTIES ARE PRODUCED IN A FULLY AUTOMATED MACHINE WITH VERY LITTLE HUMAN INTERVENTION. PATTIES WHICH HAVE BEEN PRODUCED ARE INSPECTED USING A COMPUTER VISION INSPECTION THROUGHOUT THE PROCESS. THE FINAL STEP OF THE PROCESS IS TO PLACE THE PATTIES ON THE CARD, WHICH IS DONE AUTOMATICALLY BY THE MACHINE. THERE IS A VISION SYSTEM WHICH THEN TAKES A PICTURE OF THE 10 STRINGS ON THE CARD AND ONLY ALLOWS IT TO PASS IF THERE WERE 10 STRINGS FOUND. THE AUTOMATED MACHINE USED TO PRODUCE THIS PRODUCT USES A VISION INSPECTION SYSTEM TO 'COUNT' THE NUMBER OF PATTIES ON THE CARD. THE SYSTEM IS VERY ROBUST AT FINDING ANY MISSING PATTIES. THEREFORE THE MOST PROBABLE ROOT CAUSE LIES IN OPERATOR ERROR. BETWEEN 05NOV2019 AND 30JUN2020, APPROXIMATELY 2,200 MDRS SUBMITTED ELECTRONICALLY BY INTEGRA LIFESCIENCES VIA TRACKWISE, INTEGRA'S COMPLAINT HANDLING SYSTEM, WERE NOT RECEIVED BY CDRH DUE TO A COMPUTER SYSTEM ISSUE. WITHIN THIS TIME PERIOD, AN ERROR WITH INTEGRA'S MIDDLEWARE, WHICH FACILITATES COMMUNICATIONS BETWEEN TRACKWISE AND THE FDA SYSTEM, CAUSED THE COMPLAINT RECORDS TO CLOSE AND INDICATE WE HAD RECEIVED AN ACKNOWLEDGEMENT 3 FROM THE FDA WHEN WE HAD NOT. INTEGRA INTERPRETED THE ACKNOWLEDGEMENT AS A SUCCESSFUL SUBMISSION; HOWEVER, SUBSEQUENT INVESTIGATION REVEALED THE ACKNOWLEDGEMENT 3 RECEIVED WAS FROM OUR MIDDLEWARE AND NOT FROM THE FDA (THESE ACKNOWLEDGEMENTS HAVE BEEN RETAINED AS PART OF THE DOCUMENTATION OF THE MDR). THE MALFUNCTION WAS RELATED TO THE RELOCATION OF THE TRACKWISE APPLICATION TO A NEW DATA CENTER DURING THE TRANSITION OF INTEGRA'S CORPORATE HEADQUARTERS FROM PLAINSBORO, NJ TO PRINCETON, NJ. PREVIOUSLY, INTEGRA HAD BEEN SUCCESSFULLY RECEIVING ACKNOWLEDGEMENTS 1, 2, AND 3 FROM THE FDA, AND OUR RECORDS REFLECT THESE ACKNOWLEDGEMENTS, INCLUDING THE DATE AND TIME STAMPS. CAPA PR 229048 AND NC 20-011 HAVE BEEN OPENED BY INTEGRA TO FURTHER INVESTIGATE THE NONCONFORMANCE AND DEVELOP A CORRECTIVE ACTION PLAN. THE MIDDLEWARE ERROR HAS BEEN CORRECTED, AND INTEGRA HAS FILED MDRS SINCE THE CORRECTION AND VERIFIED THAT THE APPROPRIATE ACKNOWLEDGEMENTS HAVE BEEN RECEIVED FROM THE FDA. INTEGRA IS RESUBMITTING ALL IMPACTED MDR REPORTS FOR THE TIME PERIOD 05NOV2019 THROUGH 30JUN2020. INTEGRA LIFESCIENCES CONTACTED (B)(4) OFFICE OF PRODUCT EVALUATION AND QUALITY ON JULY 8-9, 2020 TO REPORT THESE ISSUES REGARDING MDR REPORTS.

Additional Manufacturer Narrative

ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT ONLY 9 PATTIES IN THE PACKET.