BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R & R SIDEKICK TOMAHAWK

    MDR report key: 1210887 · Received October 21, 2008

    Report

    Report Number
    MW5008734
    Event Type
    Injury
    Date Received
    October 21, 2008
    Date of Event
    July 14, 2008
    Report Date
    October 21, 2008
    Manufacturer
    WRIGHT MEDICAL
    Product Code
    HTY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HARDWARE FAILURE. IN 2008, PT UNDERWENT A LEFT HALLUX FIRST METATARSAL ARTHRODESIS WITH AN EXTERNAL FIXATOR. ON FOLLOW-UP VISITS AFTER SURGERY, THE PHYSICIAN NOTED THE FIXATOR WAS LOOSE AND WAS RE-TIGHTENED. AFTER OTHER FOLLOW-UP VISITS, IT WAS NOTED THAT THERE WAS DISPLACEMENT OF THE PROXIMAL PHALANX. ON THE FOLLOWING MONTH, THE PT WAS TAKEN FOR REMOVAL OF LEFT EXTERNAL FIXATOR AND REVISION OF LEFT HALLUX METATARSOPHALANGEAL FUSION SECONDARY TO HARDWARE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 R & R SIDEKICK TOMAHAWK EXTERNAL FIXATOR DEVICE HTY WRIGHT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ARTICULATING BAR| 4-3.0 PINS| 2-COMPRESSION NUTS| 2- PIN CLAMPS-