BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-03877

    MDR report key: 3193526 · Received June 27, 2013

    Report

    Report Number
    2520274-2013-03877
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 28, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    DZK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE KWIRE BROKE WITHIN THE ONE OF THE GUIDE HOLES ON THE DRILL TEMPLATE. THE KWIRE WAS SUCCESSFULLY REMOVED FROM THE TEMPLATE USING A DRILL BIT. THE DRILL BIT BROKE IN THE REMOVAL PROCESS. THIS IS 2 OF 3 REPORTS FOR THE SAME EVENT, COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294387 DZK SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1