BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRASSELER

    MDR report key: 3052837 · Received April 5, 2013

    Report

    Report Number
    MW5029700
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 5, 2013
    Manufacturer
    BRASSELER USA MEDICAL LOGISTICS & MANUFACTURING FACILITY
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    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
    139652 BRASSELER DRILL BIT 125 MM/6.4 MM TWIST BIT HWE BRASSELER USA MEDICAL LOGISTICS & MANUFACTURING FACILITY 946095

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR