BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-HANDLE WITH AO ATTACHMENT

    MDR report key: 4200041 · Received October 21, 2014

    Report

    Report Number
    9615741-2014-00054
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 29, 2014
    Report Date
    September 29, 2014
    Manufacturer
    NEWDEAL S.A.
    Product Code
    HSB
    PMA / PMN Number
    K091788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICES INVOLVED IN THE REPORTED INCIDENT HAVE NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED; DURING A STANDARD CHECK-UP OF THE PANTA NAIL INSTRUMENTS, THE HANDLE OF THE T HANDLE IS LOOSENED. THE DEVICE WAS NOT IN CONTACT WITH THE PT. ADDITIONAL INFO RECEIVED ON 10/02/2014. THERE WAS NO DELAY IN SURGERY; THE ISSUE WAS DETECTED IN THE DISTRIBUTOR'S WAREHOUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670011 T-HANDLE WITH AO ATTACHMENT PANTA NAIL HSB NEWDEAL S.A. F6FF

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown