Events

Alerta De Seguridad O Notificaciones De Seguridad para Flexible handle (part no. 355.280), used with the Simplified Universal Nail System (SUN) and the Universal Nail System (UNI)

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom 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
    Safety alert / Field Safety Notice
  • ID del evento
    MDA/2013/059
  • Número del evento
    CON297581
  • Fecha
    2013-08-01
  • Fecha de publicación del evento
    2013-08-01
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON297581?tabName=allTabs
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notas adicionales en la data
  • Causa
    Due to the design of the instrument, the device may not be adequately cleaned. this could result in a risk of infection to the patient. the manufacturer has redesigned the affected part and issued a field safety notice advising on the replacement and return of the affected device.
  • Acción
    Identify and quarantine the affected device. Contact the manufacturer for a replacement device. Until replacement devices are received, use an alternative fixation method for insertion procedures and postpone removal procedures except where there is no alternative. Decontamination units e.g. sterilisation departments Medical directors Orthopaedic departments Orthopaedic surgeons Staff involved in the management of patients implanted with nailing systems Theatre managers Theatre staff

Device

Flexible handle (part no. 355.280), used with the Simplified Universal Nail System (SUN) and the ...
  • Modelo / Serial
  • Descripción del producto
    Orthopaedic instrument. Flexible handle (part no. 355.280), used with the Simplified Universal Nail System (SUN) and the Universal Nail System (UNI). The flexible handle is used during the insertion of the universal tibial nail, and femoral universal nail and the extraction of all universal nails. All devices of the old design, where the handles are perpendicular to the threaded section, are affected by this recall - see figures below for a visual comparison of the old and new design. The affected flexible handle (part no. 355.280) is always attached to the hammer guide (part no. 355.220).
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH