BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFNA BLADE

    MDR report key: 2150667 · Received June 24, 2011

    Report

    Report Number
    8030965-2011-00289
    Event Type
    Injury
    Date Received
    June 24, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 16, 2011
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    KTT
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNABLE TO PROVIDE THE PMA/510K NUMBER. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(6) INDICATES A CLINIC IN (B)(6) REPORTED: THE STANDARD PFNA BLADE WAS USED WITH A PFNA II NAIL RESULTING IN THE JAMMING OF BOTH IMPLANTS. THE SURGERY WAS PROLONGED DUE TO THE JAMMING OF THE IMPLANTS. THE BLADE AND NAIL WERE EVENTUALLY REMOVED AND REPLACED WITH AN ALTERNATIVE PRODUCT. THIS IS TWO OF TWO REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFNA BLADE PFNA BLADE KTT SYNTHES BETTLACH NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention NAIL