BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METAL CUTTING WH-2

    MDR report key: 456027 · Received April 18, 2003

    Report

    Report Number
    1625507-2003-00111
    Event Type
    Malfunction
    Date Received
    April 18, 2003
    Date of Event
    January 7, 2003
    Report Date
    February 19, 2003
    Manufacturer
    MEDTRONIC MIDAS REX
    Product Code
    HBE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    TOOL SNAPPED OFF DURING SPINAL FUSION. NO PT INJURY. THE TOOL WAS DISCARDED AND LOT NUMBER WAS UNK. BACK UP UNIT WAS USED TO COMPLETE THE PROCEDURE. THIS WAS REPORTED ON FOLLOW UP TO MEDWATCH REPORT. INITIALLY MMR BECAME AWARE OF THE EVENT WHEN A COPY OF MEDWATCH REPORT WAS RECEIVED. USER FACILITY MEDWATCH REPORT RECEIVED AT MMR ON 2/19/2003. THE STATEMENT ON MEDWATCH WAS AS FOLLOWS: "WHILE ATTEMPTING TO USE A MIDAS REX DURING SPINAL FUSION, BURR SNAPPED OFF IN SHAFT OF MIDAS HANDPIECE. UNABLE TO CONTINUE USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 METAL CUTTING WH-2 SURGICAL DISSECTING TOOL HBE MEDTRONIC MIDAS REX NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN