BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KX+FEM IMPACTOR

    MDR report key: 190786 · Received October 6, 1998

    Report

    Report Number
    2219689-1998-00535
    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 HANDLE 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