Events

Retiro De Equipo (Recall) de TFN-ADVANCED Proximal Femoral Nailing System (TFNA)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes.

¿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-2015-RN-00372-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-05-05
  • 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-2015-RN-00372-1
  • 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
    Johnson & johnson is initiating a recall for product correction for the depuy synthes tfn-advanced proximal femoral nailing system (tfna). the tfna system is intended for treatment of proximal femoral fractures.There is the potential that the tfna nails received before march 31, 2015 from the affected lots were assembled with a locking mechanism too close to the top of the nail. this problem was due to human error during assembly of the device with the manufacturer and no design changes are required.Therefore locking mechanism could:· prevent the connecting screw from fully tightening the insertion handle to the nail resulting in a loose or toggling nail in the insertion handle, or· cause the bottom of the connecting screw to tighten against the top of the locking mechanism preventing advancement of the locking mechanism.The above may lead to delays in surgery with the potential for complications associated with prolonged anaesthesia.
  • Acción
    A workaround is being provided for users via the customer letter. This action has been closed-out on 08/08/2016.

Device

TFN-ADVANCED Proximal Femoral Nailing System (TFNA)

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes