BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDTRONIC ELECTRIC BONE MILL

    MDR report key: 3685250 · Received March 12, 2014

    Report

    Report Number
    MW5034945
    Event Type
    Other
    Date Received
    March 12, 2014
    Report Date
    March 11, 2014
    Manufacturer
    MEDTRONIC
    Product Code
    LYS
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MEDTRONIC MIDAS REX ELECTRIC BONE MILL CLEANING INSTRUCTION DOES NOT SPECIFY HOW TO REMOVE NEUTRAL ENZYMATIC DETERGENT BEFORE DRYING AND STERILIZATION. RESIDUAL ENZYMATIC DETERGENT COULD TRIGGER AN INFLAMMATORY RESPONSE IN A PATIENT EXPOSED DURING SURGERY. MEDTRONIC WAS CONTACTED AND STATED THEY HAVE NO PLANS TO MODIFY OR UPDATE THE IFU. THEY KNOW THEY HAVE NOT PROVIDED A METHOD TO RINSE THE DETERGENT FROM THEIR DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149180 MEDTRONIC ELECTRIC BONE MILL ELECTRIC BONE MILL LYS MEDTRONIC

    Patients

    Seq Age Sex Outcome Treatment
    1