BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8-10MM STARTER/SIZER AWL

    MDR report key: 2885220 · Received December 18, 2012

    Report

    Report Number
    2249697-2012-02743
    Event Type
    Injury
    Date Received
    December 18, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 3, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE SURGEON WAS DOING A PRIMARY TOTAL HIP PROCEDURE ON PT'S RIGHT HIP, WHILE USING THE OPENING REAMER, THE REAMER BROKE INSIDE THE PT'S FEMUR AT ONE OF THE HASH MARKS ON THE REAMER AND THE BROKEN PIECE WAS THEN STUCK INSIDE THE FEMUR. SURGEON HAD TO CREATE A WINDOW IN THE PT'S FEMUR TO GET THE BROKEN PIECE OUT AND THERE WAS A DELAY OF ONE HOUR AND TWENTY MINUTES AS A RESULT OF THIS .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8-10MM STARTER/SIZER AWL INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention