BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.0MM TROCAR 176MM

    MDR report key: 2950078 · Received February 6, 2013

    Report

    Report Number
    2530088-2013-10088
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    January 8, 2011
    Report Date
    January 8, 2011
    Manufacturer
    SYNTHES (USA) BRANDYWINE
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED AND EVALUATED. ALLEGED MALFUNCTION COULD NOT BE REPRODUCED. DEVICE MET SPECIFICATIONS. DHR HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A TFN PROCEDURE, THERE WAS A MISALIGNMENT ISSUE. THE LOCKING SCREW WAS NOT LINING UP. THE JIG WAS REMOVED TO COMPLETE THE SURGERY FREE HAND. SURGERY TIME WAS EXTENDED LESS THAN ONE HOUR. THIS IS 5 OF 10 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50409 4.0MM TROCAR 176MM FZX SYNTHES (USA) BRANDYWINE 4884035

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention