BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERTAN

    MDR report key: 1884924 · Received October 28, 2010

    Report

    Report Number
    1020279-2010-00306
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    August 25, 2010
    Report Date
    March 10, 2011
    Manufacturer
    SMITH-NEPHEW INC.
    Product Code
    LYT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE ANALYSES CONDUCTED DURING THIS INVESTIGATION, IT WAS SHOWN THAT THE T-HANDLE FRACTURED IN THE 'EAR' OF THE HANDLE IN THE CLAMPING JAW, LIKELY FROM STATIC BENDING OR TORSIONAL OVERLOAD. AN OVERLOAD FRACTURE CAN OCCUR IF THE MECHANICAL LOADS APPLIED TO THE DEVICE EXCEED THE STRENGTH OF THE MATERIAL. NO MATERIAL OR MANUFACTURING DEVIATIONS WERE FOUND DURING THIS INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGERY TIME WAS EXTENDED DUE TO A BROKEN T-HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERTAN T-HANDLE LYT SMITH-NEPHEW INC. 09ACT0010

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization