BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D/M LG TROCH PASSER

    MDR report key: 1933264 · Received December 15, 2010

    Report

    Report Number
    2249697-2010-01744
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 19, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # 6704-9-770, LOT # TACC808, DESCRIPTION: D/M LG TROCH PASSER. MANUFACTURE DATE: 09/13/2002.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "THE CABLE PASSER WHEN BEING PASSED AROUND THE PROXIMAL FEMUR THE HANDLE BROKE OFF. A SECOND ONE WAS OPEN AND THE SAME THING HAPPENED. IT APPEARS TO BE BIOBURDEN INSIDE THE BROKE HANDLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 D/M LG TROCH PASSER INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA TACA61L

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention