BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING DRILL EXTENDER

    MDR report key: 1592964 · Received January 29, 2010

    Report

    Report Number
    3005990499-2010-00002
    Event Type
    Malfunction
    Date Received
    January 29, 2010
    Date of Event
    January 1, 2009
    Report Date
    November 4, 2009
    Manufacturer
    KEYSTONE
    Product Code
    DZA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION CONFIRMED THE DRILL EXTENDER WAS BROKEN. SHIPMENT HISTORY FOR THE LOT REVEALED THAT SEVERAL ORDERS WITH THIS LOT WERE SHIPPED TO THE REPORTER, ALL WITHIN THE 90 DAY WARRANTY PERIOD. THE USAGE OF THE DEVICE WAS REQUESTED BUT NOT RECEIVED. THE ROOT CAUSE OF THE FAILURE WAS NOT DETERMINED.

    Description of Event or Problem · 1

    DRILL EXTENDER BROKE AFTER HIGH TEMPERATURE STERILIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING DRILL EXTENDER DZA KEYSTONE 022756

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK