BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCHANZ SCREW

    MDR report key: 1970012 · Received January 21, 2011

    Report

    Report Number
    MW5019088
    Event Type
    Malfunction
    Date Received
    January 21, 2011
    Date of Event
    December 14, 2010
    Report Date
    January 13, 2011
    Manufacturer
    SYNTHES
    Product Code
    KTT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING APPLICATION OF AN EXTERNAL FIXATOR FOR LEFT WRIST FRACTURE, A SCHANZ SCREW BROKE OFF INSIDE THE BONE. WAS NOT REMOVED DUE TO LOCATION AND HEALING EXPECTED TO OCCUR. # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCHANZ SCREW SCHANZ SCREW KTT SYNTHES 294.771 A8MA519

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR