BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRASSELER USA TWIST DRILL

    MDR report key: 5666087 · Received May 21, 2013

    Report

    Report Number
    2025102-2013-00004
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 3, 2013
    Report Date
    May 21, 2013
    Manufacturer
    BRASSELER USA, MEDICAL, LLC
    Product Code
    HBE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO LOT INFO PROVIDED BY CUSTOMER. NO PT INFO PROVIDED.

    Description of Event or Problem · 1

    A 2.5 BIT FROM DRILL BROKE OFF INSIDE THE BONE DURING AN EPIPHYSIODESIS RIGHT TIBIAL PROCEDURE. APPROX 1 INCH FRAGMENT OF THE DRILL BIT WAS RETAINED IN THE BONE, AND REMOVED BY THE SURGEON WITH NO APPARENT HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226182 BRASSELER USA TWIST DRILL TWIST DRILL HBE BRASSELER USA, MEDICAL, LLC KM166-00-08

    Patients

    Seq Age Sex Outcome Treatment
    1