BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXTORQUE 3.7 MM SQUARE DRILL BIT (GREEN)

    MDR report key: 4107447 · Received September 12, 2014

    Report

    Report Number
    3005039508-2014-00011
    Event Type
    Malfunction
    Date Received
    September 12, 2014
    Date of Event
    August 14, 2014
    Report Date
    August 28, 2014
    Manufacturer
    ORTHOHELIX SURGICAL DESIGNS, INC.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE INITIAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.

    Description of Event or Problem · 1

    DURING SURGERY THE SURGEON SAW THAT THE DRILL BIT BROKE OFF INTO THE PATIENT BONE. THE BROKEN DRILL BIT REMAINS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566632 MAXTORQUE 3.7 MM SQUARE DRILL BIT (GREEN) NONE HWC ORTHOHELIX SURGICAL DESIGNS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1