BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-01552

    MDR report key: 3012041 · Received March 20, 2013

    Report

    Report Number
    2520274-2013-01552
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 22, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON (B)(6) 2013, IT WAS REPORTED THE PFNA NAIL WAS BROKEN. THE BROKEN NAIL WAS REMOVED WITHOUT INCIDENT. THIS REPORT IS FOR AN UNKNOWN PFNA NAIL, 10MM X 360MM 130DEGREES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116885 HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention