BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-COAT MICRO HDL KERR RONG THIN 8IN 2MM

    MDR report key: 10832657 · Received November 12, 2020

    Report

    Report Number
    8010386-2020-00002
    Event Type
    Malfunction
    Date Received
    November 12, 2020
    Date of Event
    September 23, 2020
    Report Date
    November 13, 2020
    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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MICROSCOPIC INSPECTION OF THE DEVICE REVEALED EVIDENCE OF REPAIR, AND/OR REWORK BY UNAUTHORIZED THIRD PARTIES. NOTCHES AND/OR GRINDING MARKS ON THE CUTTING EDGE, THE SCREWS AND THE SLIDER OF THE RONGEUR INDICATE FAULTY REPAIR WORK THAT DULLED THE CUTTING EDGE OF THE RONGEUR, MAKING IT NECESSARY TO APPLY GREATER FORCE DURING USE. THE INCREASE IN FORCE AND THE DIMINISHED MATERIAL STABILITY OF THE CUTTING EDGE COMBINED TO FRACTURE THE TIP. HARDNESS OF THE RETURNED DEVICE WAS TESTED, AND FOUND TO CONFORM TO SPECIFICATIONS. REVIEW OF MANUFACTURING DOCUMENTS SHOWED NO NONCONFORMITIES NOR REWORK. THE DEVICE CONFORMED TO SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    DURING A LAMINECTOMY, A TINY PIECE OF THE RONGEUR TIP BROKE OFF AND FELL INTO THE INCISION AREA BETWEEN THE LAMINA AND THE DURA. X-RAYS WERE TAKEN. THE PROCEDURE WAS COMPLETED AS PLANNED, AND THE PATIENT'S OUTCOME WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1293781 T-COAT MICRO HDL KERR RONG THIN 8IN 2MM KERRISON RONGEUR HAE S.U.A. MARTIN GMBH & CO. KG XMEM07

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention