Events

Retiro De Equipo (Recall) de Omega+ Lag Screw Ø13X110MM ST

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Stryker Australia Pty Ltd.

¿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-00526-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-04-28
  • 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-00526-1
  • 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
    Stryker gmbh has received a customer complaint that the lag screw would not completely cannulate as the guide wire would not pass through the cannula of the screw. no harm was reported. it was found on investigation that the obstruction is related to a metal burr in the cannula of the screw which was not removed during manufacturing causing obstruction. the obstruction in the cannula of the screw is easily recognisable for the user. in most cases the surgeon would detect significant resistance when passing the lag screw over the guide wire before it touches the skin and would not continue using the screw. a different screw would be available and used, resulting in a minor delay in surgery of <15 minutes. if the surgeon does not notice or ignores the resistance, then surgical complications related to the guide wire being stuck in the cannulated screw and/or the guide wire being pushed out of the femoral head could theoretically occur.
  • Acción
    Stryker is advising customers to immediately inspect inventory and quarantine affected product. Stryker will coordinate the return and replacement of the product.

Device

Omega+ Lag Screw Ø13X110MM ST
  • Modelo / Serial
    Omega+ Lag Screw Ø13X110MM STItem Number: 33625110Lot Number: V06279Ø13X105MM STItem Number: 33625105Lot Number: V06269ARTG Number: 119660
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DHTGA