BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL ALIGNMENT HANDLE

    MDR report key: 1962841 · Received December 22, 2010

    Report

    Report Number
    2249697-2010-01880
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    MR. (B)(6), HEAD OF THE CENTRAL STERILIZATION DEPARTMENT, REPORTED VIA OUR SALES REP, A. H., THAT DESPITE A CONSTANT STERILIZATION PROCESS, THE PLASTIC GRIPS OF THE INSTRUMENTS DISSOLVE. PARTS DROP OFF. FOR CLEANING ARE (B)(4) FROM DR (B)(6) USED. LOOSE PARTS COULD REACH THE OPERATION AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIBIAL ALIGNMENT HANDLE INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other