Events

Retiro De Equipo (Recall) de Ankle Arthrodesis Nail 611AFN Drill Bit

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Tornier Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2017-RN-00680-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-06-06
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00680-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Despite being guided by drill reference mju775, cases of drill breakage during surgery have been received by wright medical australia. this issue has been replicated by the manufacturer in internal tests. breakage of the tip of the drill during use may lead to the need to remove debris and a delay in surgery.
  • Acción
    Wright Medical is advising users that in order to optimize the drilling technique, there will be a modification to the cutting edge of the drill. Users will be contacted for the return and exchange when replacements become available (from November 2017). In the interim, users are advised to apply the drilling force in the axis of the drill (as illustrated in the recall notification).

Device

Ankle Arthrodesis Nail 611AFN Drill Bit
  • Modelo / Serial
    Ankle Arthrodesis Nail 611AFNDrill Bit Model Number: MJU777Lot Numbers 11D463 and 12E794ARTG Number: 112287
  • Manufacturer
    Tornier Pty Ltd

Manufacturer

Tornier Pty Ltd