BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-02346

    MDR report key: 3092402 · Received May 3, 2013

    Report

    Report Number
    2520274-2013-02346
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    March 4, 2013
    Report Date
    April 8, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT USED FOR TREATMENT, NOT DIAGNOSIS. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE FOR AN INTERTROCHANTERIC FEMORAL FRACTURE ON (B)(6) 2013, A BLADE BECAME STUCK AND THE CONNECTION PART OF THE BLADE WAS BROKEN OFF. THIS OCCURRED WHEN THE BLADE WAS INSERTED DEEPLY INTO A BONE HEAD DURING A JPA OPERATION. THE SURGEON TRIED TO FREE THE BLADE USING AN EXTRACTOR, AND THE CONNECTION PART OF THE BLADE WAS BROKEN OFF. THE ENTIRE BLADE WAS RETRIEVED AND RESET. THE OPERATION WAS COMPLETED SUCCESSFULLY. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195351 LXH SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1