BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-02926

    MDR report key: 3131722 · Received May 29, 2013

    Report

    Report Number
    2520274-2013-02926
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 1, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES GMBH REPORTS AN EVENT IN (B)(4) AS FOLLOWS: ON (B)(6) 2013, THE SURGEON TRIED TO REMOVE THE LOCKING CAP FOR A LITTLE OF COMPRESSION, HOWEVER HE COULDN'T REMOVE BOTH AT L4. THE SURGEON TRIED BACKWARD AND FORWARD SEVERAL TIMES AND THEN WITH A PERSUADER. THE SURGEON TIGHTENED TO 12NM BY A NEW RELEASE TOOL. THE SURGEON COULD STILL NOT MOVE IT BACK AND FORTH. THE SURGEON DECIDED TO USE A NORMAL HANDLE, BECAUSE OUT OF TORQUE. TWO SHAFTS AND ONE HANDLE WERE BROKEN. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE OPERATION WAS FINISHED AFTER THE COMPRESSION. THIS REPORT IS FOR AN ADDITIONAL SCREWDRIVER. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236365 HXX SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1