BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANA OPERATING ROOM TABLE

    MDR report key: 4040103 · Received May 18, 2014

    Report

    Report Number
    2921578-2014-00012
    Event Type
    Malfunction
    Date Received
    May 18, 2014
    Date of Event
    March 15, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    JEA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FEMORAL LIFTER BROKE DURING ANTERIOR TOTAL HIP REPLACEMENT. THE BOLT SNAPPED INSIDE THE HOOK POST WHICH RESULTED IN A SMALL FEMUR FRACTURE FOR THE PATIENT. THE SURGEON IS AWARE AND NO FURTHER MEDICAL INTERVENTION/TREATMENT WAS REQUIRED TO THE FEMUR FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295216 HANA OPERATING ROOM TABLE TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED JEA MIZUHO ORTHOPEDIC SYSTEMS, INC. 6875

    Patients

    Seq Age Sex Outcome Treatment
    1