BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRI DIST AUGMENT TRL SZ8 10MM

    MDR report key: 1915357 · Received November 17, 2010

    Report

    Report Number
    2249697-2010-01561
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 26, 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THIS IS THE SAME EVENT AS: MFR# 2249697-2010-01558, MFR# 2249697-2010-01559, MFR# 2249697-2010-01560, MFR# 2249697-2010-01562, MFR# 2249697-2010-01563, MFR# 2249697-2010-01564.

    Description of Event or Problem · 1

    IT WAS REPORTED: "STERILIZATION DEPT REFUSED TO CLEAN AND STERILIZE DUE TO COMPONENTS BEING CRACKED." TWO DEVICES OF THE SAME LOT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRI DIST AUGMENT TRL SZ8 10MM INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA KM3L69

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other