BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYOMA SCREW 5MM, 32CM

    MDR report key: 499436 · Received December 5, 2003

    Report

    Report Number
    2430952-2003-00019
    Event Type
    Malfunction
    Date Received
    December 5, 2003
    Report Date
    December 5, 2003
    Manufacturer
    TROKAMED HENGSTLER GMBH
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    ROOT OF THE SHAFT BROKE OFF THE INSTRUMENT DURING A SURGICAL PROCEDURE. THE USER REPORTED NOT USING FORCE WHEN MANIPULATING THE INSTRUMENT. THIS WAS THE FIRST TIME THE INSTRUMENT WAS USED. THE SHAFT BROKE IN HALF AT PROXIMAL END CLOSE TO THE HANDLE. NO DISCOLORATION OF STAINLESS STEEL WAS NOTED ON THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYOMA SCREW 5MM, 32CM JARIT ENDOSCOPIC INSTRUMENT KOG TROKAMED HENGSTLER GMBH * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *