BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3940481 · Received June 12, 2014

    Report

    Report Number
    3940481
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 12, 2014
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    DWI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    THE SURGICAL RESIDENT WAS USING THE SAW AND TRYING TO TURN THE SAW RATHER ACUTELY TO CUT IN A CURVING FASHION BUT TURNED TOO QUICKLY WHICH LED TO THE BLADE BREAKING. THERE WAS NO HARM TO THE PATIENT AND THE BROKEN PIECE IMMEDIATELY REMOVED FROM THE FIELD.HTTP://WWW.STRYKER.COM/STELLENT/GROUPS/PUBLIC/DOCUMENTS/WEB_PROD/007117.PDF.THIS IS THE COMPANY BROCHURE FOR THIS PRODUCT.======================MANUFACTURER RESPONSE FOR STRYKER STERNAL SAW, (BRAND NOT PROVIDED) (PER SITE REPORTER).======================THE OPERATING ROOM (OR) CONTACTED THE MANUFACTURER REPRESENTATIVE AND THE SAW AND DRILL WERE PROVIDED TO THE REPRESENTATIVE FOR THE COMPANY TO REVIEW. THE COMPANY HAS ALL OF THE IDENTIFYING INFORMATION, SO NO LOT NUMBER OR DRILL NUMBER IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347500 * STERNAL SAW DWI STRYKER INSTRUMENTS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR