BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTA OFFSET FEM ROD DRIVER

    MDR report key: 166370 · Received May 5, 1998

    Report

    Report Number
    2219689-1998-00292
    Event Type
    Malfunction
    Date Received
    May 5, 1998
    Date of Event
    April 23, 1998
    Report Date
    May 4, 1998
    Manufacturer
    HOWMEDICA INC.
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THEH RESULTS ODF THE EVALUATION PERFORMED SUGGEST THE EVENT WAS ATTRIBUTED TO USER MISUSE.

    Description of Event or Problem · 1

    DURING AN INSERVICE, THE HANDLE OF THE ROD DRIVER BROKE OFF WHILE THE ROD WAS BEING IMPACTED. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTA OFFSET FEM ROD DRIVER INSTRUMENT LXH HOWMEDICA INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other