BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VILEX DRILL BIT

    MDR report key: 5694296 · Received June 2, 2016

    Report

    Report Number
    5694296
    Event Type
    Malfunction
    Date Received
    June 2, 2016
    Date of Event
    April 27, 2016
    Report Date
    May 3, 2016
    Manufacturer
    VILEX IN TENNESEE, INC.
    Product Code
    GFF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING BUNIONECTOMY, VILEX DRILL BIT BROKE WHILE IN USE. THE PIECE THAT BROKE AWAY WAS ABOUT 1/2 INCH IN LENGTH. AFTER NOTICING THE BREAK, THE REMAINING PIECE COULD BE VISUALIZED PROTRUDING FROM THE BONE OF THE LEFT FOOT. THE PIECE WAS REMOVED AND THE SURGEON INSPECTED THE BIT AND THE SITE AND SAID THAT NO REMAINING PIECES REMAINED IN THE FOOT. THE DRILL BIT WAS COMPARED WITH ANOTHER SIMILAR BIT AND IT APPEARED TO BE THE SAME. THE BIT WAS SEQUESTERED AND IS AVAILABLE IN THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348805 VILEX DRILL BIT BUR, SURGICAL, GENERAL & PLASTIC SURGERY GFF VILEX IN TENNESEE, INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR