Events

Retiro De Equipo (Recall) de Screwdriver Shaft, hexagonal, large, diameter 3.5mm, length 165mm, for Quick Coupling(Supplied as part of the fixation system implantation kit)

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-2017-RN-00304-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-03-02
  • 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-00304-1
  • 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 medical have received a complaint that the location slot for the screw holding sleeve was machined 3 mm out of position. the presence of a screwdriver, (part number 314.560) which is not manufactured to specification, may result in a surgical delay due to the non-conformance. the combination of the non-conforming screwdriver and a retaining sleeve will result in a situation where the surgeon will have minor difficulty interfacing the screw with the driver and sleeve, but the surgeon should still be able to insert the screw. it is important to note that the surgeon may opt to utilise the screwdriver without the retaining sleeve. the resulting surgical delay is not anticipated to be clinically significant (<15 minutes) and no additional intervention is anticipated.
  • Acción
    Customers are advised to quarantine and return the affected stock in their possession to JJM.

Device

Screwdriver Shaft, hexagonal, large, diameter 3.5mm, length 165mm, for Quick Coupling(Supplied as...
  • Modelo / Serial
    Screwdriver Shaft, hexagonal, large, diameter 3.5mm, length 165mm, for Quick Coupling(Supplied as part of the fixation system implantation kit)Part Number: 314.560Lot Number: 7722501ARTG Number: 153950
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes