BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW

    MDR report key: 6989679 · Received October 31, 2017

    Report

    Report Number
    3003898228-2017-00009
    Event Type
    Malfunction
    Date Received
    October 31, 2017
    Date of Event
    August 9, 2017
    Report Date
    October 20, 2017
    Manufacturer
    FH INDUSTRIE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    LE FORET 3.2MM S'EST COINCÉ DANS LE CANON DE PERÇAGE. LES 2 PIÈCES SONT DEVENUES INUTILISABLES ET N'ONT PAS PU ÊTRE SÉPARÉES. A 3.2 MM DRILL BIT (# 267115) BECAME BOUND UP AND COLD-WELDED INTO THE DRILL SLEEVE (# 264479). ONCE THIS OCCURRED, THE DRILL BIT AND AND DRILL SLEEVE WERE NO LONGER USABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771785 ARROW DRILL SLEEVE LXH FH INDUSTRIE

    Patients

    Seq Age Sex Outcome Treatment
    1