BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER

    MDR report key: 5273653 · Received November 16, 2015

    Report

    Report Number
    5273653
    Event Type
    Injury
    Date Received
    November 16, 2015
    Date of Event
    November 3, 2015
    Report Date
    November 16, 2015
    Manufacturer
    STRYKER
    Product Code
    HWE
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    FRACTURED LATERAL FEMORAL CONDYLE DUE TO SUDDEN SAW BLADE VIBRATION. PATIENT WAS UNDERGOING A SCHEDULED RIGHT TOTAL KNEE REPLACEMENT. THE SURGEON WAS PERFORMING A STANDARD DISTAL FEMORAL CUT WHEN THE CUT SAW VIBRATED RESULTING IN THE FRACTURING OF THE LATERAL FEMORAL CONDYLE. THE INVOLVED PIECE OF THE LATERAL CONDYLE WAS ABOUT 6 OR 7 MM WIDE AND 2CM LONG. THE FRACTURE WAS REDUCED WITH A SINGLE SCREW OF 35MM LENGTH PARTIALLY-THREADED CANCELLUS TYPE. SAW USED: STRYKER SYSTEM 7, MODEL #: 7208000000, AND SERIAL # (B)(4). SAW BLADE USED: STRYKER PERFORMANCE SERIES. MODEL # 6125-127090, SERIAL #(B)(4). (THE PACKAGING HAD BEEN DISCARDED. SERIAL #S NOTED ABOVE WERE THE TWO IN INVENTORY AT THE TIME OF THIS EVENT). BLADE REPORTED TO BEGIN VIBRATING AND CAME LOOSE IN THE SLOT OF THE SAW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757628 STRYKER STRYKER SAW BLADE PERFORMANCE SERIES HWE STRYKER 6125-127090

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention