BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER INSTRUMENTS

    MDR report key: 3281890 · Received August 7, 2013

    Report

    Report Number
    MW5031369
    Event Type
    Injury
    Date Received
    August 7, 2013
    Date of Event
    July 25, 2013
    Report Date
    July 29, 2013
    Manufacturer
    STRYKER
    Product Code
    GFA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS USING STRYKER BLADE (REF #(B)(4)) ON A PT DURING SURGERY TO CREATE A CHEVRON OSTEOTOMY. WHEN IMAGING OF THE FOOT WAS TAKEN, SMALL METAL SHARDS WERE IN THE WOUND FROM THE STRYKER BLADE. THE WOUND WAS IRRIGATED AND THE BLADE WAS REMOVED FROM SERVICE. AFTER IRRIGATION, THERE WERE RESIDUAL METAL SHAVINGS LEFT IN THE PT'S FOOT DOCUMENTED BY X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371965 STRYKER INSTRUMENTS LONG MEDIUM AGGRESSIVE BLADE GFA STRYKER 2296-3-525 31804011311602709

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention