BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 2020175 · Received March 7, 2011

    Report

    Report Number
    8030965-2011-00050
    Event Type
    Injury
    Date Received
    March 7, 2011
    Report Date
    February 22, 2011
    Manufacturer
    SYNTHES (USA)
    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

    SYNTHES IS UNABLE TO PROVIDE THE MFR, PMA/510K NUMBER AND/OR THE DATE OF MANUFACTURE, AS NO PRODUCT WAS RETURNED. 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 RECEIVED FROM (B)(6) INDICATES PATIENT STATUS POST CONSTRUCT IMPLANTATION, PFNA NAIL, PFNA BLADE AND BOLT, SELF TAPPING, ON A DATE UNK RETURNED TO SURGEON ON AN UNK DATE. IT WAS DISCOVERED THE PFNA NAIL IS BROKEN AT THE PROXIMAL LOCKING HOLE. IT WAS NOTED MEDICAL INTERVENTION WAS NEEDED. THIS IS ONE OF THREE REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI PFNA NAIL 130 DEGREES I200 KTT SYNTHES (USA) NA 2661406

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention BOLT| BLADE