BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP INSTRUMENTATION

    MDR report key: 1626499 · Received March 2, 2010

    Report

    Report Number
    1644408-2010-00071
    Event Type
    Malfunction
    Date Received
    March 2, 2010
    Date of Event
    February 5, 2010
    Report Date
    February 5, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KIH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    SURGEON TAPPED ON HANDLE OF CEMENT INSERT WHEN HE PULLED UP ON T-HANDLE, IT SNAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIP INSTRUMENTATION CEMENT PLUG INSERTER KIH ENCORE MEDICAL, L.P.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK