BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTRAINED LINER INSERTER IMPACTOR TIP 22MM

    MDR report key: 2090555 · Received April 19, 2011

    Report

    Report Number
    2249697-2011-00523
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 23, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "WHILE MALLETING HANDLE 2 TIMES, BROWN IMPACTOR PIECE ON HANDLE BROKE APART INTO PIECES AND HAD TO BE RETRIEVED FROM PT. ALL PIECES WERE RETRIEVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSTRAINED LINER INSERTER IMPACTOR TIP 22MM INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA KLPMLA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention