BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-COAT MICRO HDL KERR RONG THIN 8IN 1MM

    MDR report key: 12712428 · Received October 28, 2021

    Report

    Report Number
    8010386-2021-00001
    Event Type
    Malfunction
    Date Received
    October 28, 2021
    Date of Event
    September 20, 2021
    Report Date
    October 28, 2021
    Manufacturer
    S.U.A. MARTIN GMBH & CO. KG
    Product Code
    HAE
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE, WHICH WAS RETURNED WITHOUT THE BROKEN-OFF TIP, WAS SUBJECTED TO MICROSCOPIC INSPECTION. NOTCHES WERE OBSERVED ON THE CUTTING EDGE. PAIRED WITH THE GENERAL CONDITION OF THE CUTTING EDGE, THIS SUGGESTS THAT THE DEVICE WAS BLUNT DURING USE. AS A RESULT, AN INCREASED AMOUNT OF FORCE WOULD HAVE BEEN REQUIRED FOR CUTTING, CAUSING THE TIP TO BREAK. HARDNESS OF THE RETURNED DEVICE WAS TESTED AND FOUND TO CONFORM TO SPECIFICATIONS. REVIEW OF MANUFACTURING DOCUMENTS SHOWED NO NONCONFORMITIES NOR REWORK. THE ORIGINAL MATERIAL CERTIFICATES WERE ALSO REVIEWED AND FOUND TO BE CONFORMING. THE DEVICE CONFORMED TO SPECIFICATIONS AT THE TIME OF RELEASE. IF THE TIP IS RETURNED, THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    THE DISTAL TIP OF THE KERRISON RONGEUR BROKE OFF AND FELL INTO THE PATIENT DURING AN ACDF PROCEDURE PERFORMED UNDER FLUOROSCOPY. THE FRAGMENT WAS RETRIEVED USING A FORCEPS AND THE PROCEDURE WAS COMPLETED AS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1608360 T-COAT MICRO HDL KERR RONG THIN 8IN 1MM KERRISON RONGEUR HAE S.U.A. MARTIN GMBH & CO. KG K19XME

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention