Events

Retiro De Equipo (Recall) de Aiming Arm 125deg and Aiming Arm 130deg for TFN-ADVANCED (TFNA) System(Orthopaedic surgical guide)

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-00216-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-03-16
  • 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-00216-1
  • 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
    It was discovered that during blade insertion, the tfna guide sleeve has the potential to jam inside of the affected aiming arms which may delay disassembly and/or removal of the instruments.
  • Acción
    Johnson & Johnson Pty Limited is providing end users with work around instructions to be used until replacement stock is available. In the event that the user has difficulty with the Aiming Arm/Guide Sleeve Assembly the user can disassemble via two methods: 1) Turn the Guide Sleeve counter clockwise within the Aiming Arm to clear the jamming. This operation can be performed manually and requires relatively low force and no additional instrumentation. 2) Disassemble the Aiming Arm/Guide Sleeve assembly as one unit by disengaging the Aiming Arm coupling screw from the Insertion Handle. The instruments can then be disassembled for cleaning using the technique described in 1). Johnson & Johnson Pty Limited will provide replacement product by 1 May 2015. This action has been closed-out on 17/08/2016.

Device

Aiming Arm 125deg and Aiming Arm 130deg for TFN-ADVANCED (TFNA) System(Orthopaedic surgical guide)

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes