BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM HIPO FEMORAL BROACH

    MDR report key: 46741 · Received September 6, 1996

    Report

    Report Number
    2952369-1996-00001
    Event Type
    Malfunction
    Date Received
    September 6, 1996
    Date of Event
    August 19, 1996
    Report Date
    September 5, 1996
    Manufacturer
    HAYES MEDICAL INC.
    Product Code
    HTQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CUSTOM HIP FEMORAL BROACH PROXIMAL SECTION SEPARATED FROM DISTAL CYLINDER WHILE SURGEON WAS USING IT IN A REVISION TOTAL HIP REPLACEMENT SURGERY. THIS RESULTED IN A DELAY OF APPROXIMATELY 15 MINUTES REQUIRED FOR SURGERY WHILE THE SURGEON REMOVED THE DISTAL END FROM THE FEMORAL CANAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM HIPO FEMORAL BROACH BROACH HTQ HAYES MEDICAL INC. * 1073

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR