BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-COAT MICRO HDL KERR RONG THIN BIN 3MM

    MDR report key: 19467834 · Received June 5, 2024

    Report

    Report Number
    8010386-2024-00001
    Event Type
    Malfunction
    Date Received
    June 5, 2024
    Report Date
    June 5, 2024
    Manufacturer
    S.U.A. MARTIN GMBH & CO. KG
    Product Code
    HAE
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSTRUMENT WAS RETURNED INCOMPLETE; I.E., WITHOUT THE BROKEN-OFF TIP. THE COATING HAD BEEN REMOVED FROM PARTS OF THE TIP AND SHAFT COMPONENTS BY IMPROPERLY PERFORMED GRINDING, INDICATING THAT THE DEVICE HAD BEEN SUBJECT TO REWORK BY UNAUTHORIZED THIRD PARTIES. MICROSCOPIC EXAMINATION ADDITIONALLY REVEALED MARKS ON THE SLIDING COMPONENT, ALSO INDICATING IMPROPERLY PERFORMED REWORK. TOO MUCH MATERIAL WAS REMOVED DURING THE REPAIR PROCESS, WEAKENING THE CUTTING EDGE OF THE INSTRUMENT AND ULTIMATELY CAUSING THE DEVICE TIP TO BREAK OFF.

    Description of Event or Problem · 0

    DURING AN L4-5 POSTERIOR FUSION WITH TRANSFORAMINAL LUMBAR INTERBODY FUSION THE TIP OF THE INSTRUMENT BROKE OFF. THE SURGEON USED FORCEPS TO RETRIEVE THE INSTRUMENT PIECE WITH NO COMPLICATIONS. AN X-RAY WAS NOT NECESSARY, THE PROCEDURE WAS COMPLETED AS PLANNED AND THE PATIENT RECOVERED AS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171178 T-COAT MICRO HDL KERR RONG THIN BIN 3MM KERRISON RONGEUR HAE S.U.A. MARTIN GMBH & CO. KG 1791255 / F17XME

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown