Events

Retiro De Equipo (Recall) de Screw Inserter for TFN-Advanced (TFNA) Proximal Femoral Nailing System

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-01090-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-11-12
  • 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-01090-1
  • 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
    Upon evaluation, depuy synthes discovered that certain lots of the screw inserter may potentially be etched with an incorrect graphic. the orientation of the etched image of the oblique angle on the screw inserter may be reversed which does not correspond to the tip of the angle of the instrument. this could result in the oblique cut at the lateral end of the screw being at a 90 degree angle to the lateral cortex.It is possible that the user would identify the final lateral oblique angle is not in the desired position, which could result in repositioning the screw within the nail so that the oblique angle of the screw is flush with the bone. the screw is designed to go in either orientation to allow proper depth placement of screw which is a critical factor for the success of the implant.
  • Acción
    JJM is requesting users inspect all devices in their possession and to quarantine all non-conforming stock prior to their return to JJM. This action has been closed-out on 29/08/2016.

Device

Screw Inserter for TFN-Advanced (TFNA) Proximal Femoral Nailing System
  • Modelo / Serial
    Screw Inserter for TFN-Advanced (TFNA) Proximal Femoral Nailing SystemPart number: 03.037.025Lot Numbers: 8911887, 8911975, 9166356, 9285766, 9286671, 9319408, 9375245, 9375251, 9388359, 9388360, 9393071, 9393074, 9393075, 9393076, 9409795, 9409796, 9422892, 9422895, 9498455, 9310899, 9310900, 9319407ARTG Number: 153950
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes