Events

Notificaciones De Seguridad De Campo acerca de Trochanteric Fixation Nail (TFN), Titanium Alloy

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Synthes GmbH.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2013-09-27
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    Through internal investigation synthes identified the potential for non-conforming helical blades to be distributed to the field. helical blades, which are part of the tfn system, may have one or more dimensional features out of tolerance. the potential features that may be out of tolerance include the inner diameter of the helical blade where the guide wire passes and the dimensional features that allow for the helical blade and insertion instrument to mate. these non-conformances are not immediately apparent and the following is a summary of the potential outcomes that could occur if a patient is exposed to non-conforming product.

Device

Trochanteric Fixation Nail (TFN), Titanium Alloy
  • Modelo / Serial
    Part Description Part Number Lot Number 456300 - 456.310 & 456,650 5615864 Helical Blade for TFN. itanium Alloy through 456.3003 - 455.3103 3. 7423581 456.6505
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH