BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOHELIX DRILL BIT

    MDR report key: 4294296 · Received November 26, 2014

    Report

    Report Number
    3005039508-2014-00015
    Event Type
    Malfunction
    Date Received
    November 26, 2014
    Date of Event
    August 22, 2014
    Report Date
    November 7, 2014
    Manufacturer
    ORTHOHELIX SURGICAL DESIGNS, INC.
    Product Code
    HTW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PT UNDERGOING A CALCANEAL SLIDE OSTEOTOMY AND TALONAVICULAR JOINT FUSION. DURING THE FUSION OF THE TALONAVICULAR JOINT AND THE WHOLE PLACING THE FOURTH SCREW, AT THE TIME OF DRILLING, THE DRILL BIT BROKE. THE DRILL BIT SHOULD BE SECURE. IT DID NOT PROBE PLANTARLY THROUGH THE CORTEX OF THE NAVICULAR AND DORSALLY, IT WAS NOT ABLE TO BE PULLED OUT, IT WAS LEFT IN THE FOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769338 ORTHOHELIX DRILL BIT NONE HTW ORTHOHELIX SURGICAL DESIGNS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR