BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDAS REX I MO

    MDR report key: 380670 · Received March 1, 2002

    Report

    Report Number
    1625507-2002-00022
    Event Type
    Malfunction
    Date Received
    March 1, 2002
    Report Date
    January 31, 2002
    Manufacturer
    MEDTRONIC MIDAS REX
    Product Code
    HBB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    DISSECTING TOOLS WHIP WHEN PUT INTO THE MOTOR IS NOTED ON CUSTOMER REPAIR PAPERWORK. ON FOLLOW UP, IT WAS REPORTED THAT "IT FELT LIKE THE THREADS WERE STRIPPED INSIDE WHERE THE TOOL FIT AND THE TOOL SEEMED TO NOT TURN SMOOTHLY". THE BEST DESCRIPTIVE WORD SHE COULD THINK OF WAS THAT THE "TOOL WOBBLED". HOWEVER, THE PROCEDURE WAS COMPLETED WITH NO PROBLEMS. AFTER SURGERY THE EQUIPMENT WAS DISASSEMBLED AND SENT FOR REPAIR. NO PT INJURY AND NO DELAYS WERE EXPERIENCED. THERE IS NO INFO AS TO WHAT TOOL WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIDAS REX I MO PNEUMATIC SURGICAL DRILL, MIDAS HBB MEDTRONIC MIDAS REX NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO MIDAS REX STRAIGHT ATTACHMENT B.