BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGIMEND 2.0 10X15 CM

    MDR report key: 10279255 · Received July 15, 2020

    Report

    Report Number
    3004170064-2020-00003
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Date of Event
    February 24, 2020
    Report Date
    February 24, 2020
    Manufacturer
    TEI BIOSCIENCES INC
    Product Code
    FTM
    PMA / PMN Number
    K083898
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION THEREFORE THE FAILURE ANALYSIS TO IDENTIFY ROOT CAUSE TO THE END USER'S EXPERIENCE COULD NOT BE DETERMINED. THE REPORTED COMPLAINT WAS NOT CONFIRMED. BASED ON THE DHR REVIEW CONDUCTED, THERE IS NO INDICATION THAT THE MANUFACTURING, QUALITY INSPECTIONS OR FINAL PACKAGING/LABELING PROCESSES MAY HAVE CONTRIBUTED TO THIS COMPLAINT. ALL EBM SKINS WERE TESTED AND CHARACTERIZED APPROPRIATELY AND THE IFU IS CLEAR REGARDING INSTRUCTIONS FOR USE BY THE CLINICIAN. ADDITIONALLY, ALL FINISHED GOODS LOTS MET RAW MATERIAL, IN-PROCESS AND FINISHED GOODS RELEASE ACCEPTANCE CRITERIA FOR ALL REQUIRED INSPECTIONS AND TESTS. THERE WERE NO ANOMALIES FOUND IN THE DHR REVIEW. 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)(6) , DIRECTOR OF REGULATORY PROGRAMS, OFFICE OF PRODUCT EVALUATION AND QUALITY AND (B)(6) , ASSISTANT DIRECTOR, MDR TEAM, OFFICE OF PRODUCT EVALUATION AND QUALITY ON JULY 8-9, 2020 TO REPORT THESE ISSUES REGARDING MDR REPORTS.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE IS STILL IMPLANTED AND WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION . THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A HEALTH PROFESSIONAL REPORTED THAT ON (B)(6) 2020, SURGIMEND (ID 606-200-006) WAS SUPPOSED TO BE USED IN A ROBOTIC CASE, HOWEVER THEY DISCOVERED THAT THE MESH WAS ALMOST 4MM THICK WHICH MADE IT VERY DIFFICULT TO SUTURE ROBOTICALLY WHEN TYPICALLY THE SUTURE GLIDES RIGHT THROUGH THE MESH. THE EVENT LED TO ONE HOUR SURGICAL DELAY DUE TO PRODUCT BEING DIFFICULT TO SUTURE ROBOTICALLY. NO PATIENT ADVERSE CONSEQUENCE DUE TO THE PRODUCT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744092 SURGIMEND 2.0 10X15 CM SURGIMEND FTM TEI BIOSCIENCES INC 1905038

    Patients

    Seq Age Sex Outcome Treatment
    1