Events

Notificaciones De Seguridad De Campo acerca de Cortex Screw fl 4.5mm

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
    2016-04-26
  • 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
    Two lots of 4.5mm cortex screws, length 20mm, may contain a 4.5mm cortex screw that is 22mm in length. the screws are both etched and labeled with the above 20mm part numbers. potential hazard: the outside package labeling and the etching on the product would indicate to the user that the screw is 2mm shorter than its actual length of 22mm. for non—sterile products, there is an opportunity to detect the issue if the screw is measured prior to placement into the tray/module. once the screw enters the operating room, either sterile or unsterile, the user should measure the screw prior to insertion. if detected at this time it may result in a surgical delay while a replacement is obtained or if the surgeon inserts the screw, determines it was the wrong length on radiographic imaging, and then removes and replaces it.

Device

Cortex Screw fl 4.5mm

Manufacturer

Synthes GmbH