BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARTER BROACH WITH DISTAL BULLET (14MM)

    MDR report key: 225655 · Received May 20, 1999

    Report

    Report Number
    2952369-1999-00004
    Event Type
    Malfunction
    Date Received
    May 20, 1999
    Date of Event
    May 19, 1999
    Manufacturer
    HAYES MEDICAL, INC.
    Product Code
    HTQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING HIP IMPLANT SURGERY, THE SURGEON USED THE STARTER BROACH WITH A 14MM DISTAL BULLET. UPON REMOVAL OF THE BROACH, THE DISTAL BULLET BROKE OFF THE STARTER BROACH AND LODGED IN THE FEMUR. THE SURGEON WAS ABLE TO REMOVE THE BROKEN COMPONENT THROUGH THE EXISTING OPENING IN THE FEMUR. THIS RESULTED IN A SURGICAL DELAY OF APPROX 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARTER BROACH WITH DISTAL BULLET (14MM) STARTER BROACH (INSTRUMENT) HTQ HAYES MEDICAL, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other| R FEMORAL HIP IMPLANT.