BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLICATOR INNER SHAFT

    MDR report key: 2772102 · Received October 4, 2012

    Report

    Report Number
    8030965-2012-00980
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Date of Event
    August 30, 2012
    Report Date
    September 6, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED: THE PIN BROKE OFF FROM THE POMMEL PORTION OF THE DEVICE AND BECAME LODGED WITHIN THE DEVICE. THE BROKEN PIN WAS RETRIEVED FROM THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APPLICATOR INNER SHAFT APPLICATOR INNER SHAFT LXH SYNTHES GMBH 7546227

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female