BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KX+FEM IMPACTOR

    MDR report key: 190782 · Received October 6, 1998

    Report

    Report Number
    2219689-1998-00536
    Event Type
    Malfunction
    Date Received
    October 6, 1998
    Report Date
    October 5, 1998
    Manufacturer
    HOWMEDICA INC.
    Product Code
    HWA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE BLACK OUTER CASING CRACKED DURING IMPACTION. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KX+FEM IMPACTOR INSTRUMENT HWA HOWMEDICA INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other