BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V. MUELLER CLEANACCESS# KERRISON RONGEUR T-COAT MICRO HANDLE

    MDR report key: 24265786 · Received February 5, 2026

    Report

    Report Number
    8010386-2026-00001
    Event Type
    Malfunction
    Date Received
    February 5, 2026
    Date of Event
    October 6, 2025
    Report Date
    February 5, 2026
    Manufacturer
    S.U.A. MARTIN GMBH & CO. KG
    Product Code
    HAE
    UDI-DI
    10885403187537
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MICROSCOPIC EXAMINATION OF THE DEVICE SHOWED THAT IT HAD BEEN SUBJECT TO REPAIR BY AN UNAUTHORIZED THIRD PARTY. THE CUTTING EDGE OF THE DEVICE HAD BEEN GROUND, REMOVING ITS PROTECTIVE COATING, WEAKENING THE FOOT PLATE, AND LIKELY CAUSING IT TO BREAK DURING USE. NOTCHES ON THE CUTTING EDGE WOULD HAVE MADE CLEAN CUTS IMPOSSIBLE AND REQUIRED INCREASED FORCE DURING USE. THE INSTRUMENT WAS RETURNED INCOMPLETE, I.E., WITHOUT THE BROKEN-OFF TIP. MATERIAL HARDNESS WAS CHECKED AND FOUND TO BE CONFORMING TO SPECIFICATIONS. REVIEW OF MANUFACTURING RECORDS REVEALED NO NONCONFORMANCE ISSUES.

    Description of Event or Problem · 0

    DURING A LAMINECTOMY PROCEDURE, THE TIP OF THE KERRISON RONGEUR BROKE AND FELL INTO THE SURGICAL FIELD. IT WAS RETRIEVED WITH A BAYONET FORCEPS. THE PATIENT WAS FINE AND THE PROCEDURE WAS COMPLETED AS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328626 V. MUELLER CLEANACCESS# KERRISON RONGEUR T-COAT MICRO HANDLE KERRISON RONGEUR HAE S.U.A. MARTIN GMBH & CO. KG G21XME / 2190876 10885403187537

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown