Events

Retiro De Equipo (Recall) de Cortex Screw Ø 4.5mm, self-tapping, length 20mm, Pure Titanium

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-2016-RN-00570-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-05-03
  • 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-2016-RN-00570-1
  • 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
    The affected part and lot numbers of the 4.5mm cortex screws, length 20mm, may contain a 4.5mm cortex screw that is 22mm in length; the screws are both etched and labelled with the affected 20mm part numbers.The outside package labelling and the etching on the product would indicate to the user that the screw is 2mm shorter than its actual length of 22mm. if detected prior to insertion it may result in a surgical delay while a replacement is obtained or if the surgeon inserts the screw, determines it was the wrong length on radiographic imaging, and then removes and replaces it.In addition, the potential harm of damage to surrounding structures including damage to articular surface during insertion could occur, depending upon the location and angle of screw. a screw that is too long can also result in soft tissue damage (soft tissue irritation) if not recognised during the procedure. at this time there have been no reports of patient involvement.
  • Acción
    JJM is advising users to inspect stock and quarantine the affected units prior to their return to JJM. Past surgical results should be reviewed at the discretion of the surgeon for patients who have been implanted with screws from this particular lot number. This action has been closed out on 19/01/2017.

Device

Cortex Screw Ø 4.5mm, self-tapping, length 20mm, Pure Titanium

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes