Events

Retiro De Equipo (Recall) de Beaver 4.0mm Banana Blade

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Smith & Nephew 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-2016-RN-00093-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-01-22
  • 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-00093-1
  • 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
    A number of customer complaints have been received indicating that during arthroscopic hip surgery the blades are experiencing brittle fracture.In the event the instrument breaks, the failure is visually obvious to the user and the broken blade can be retrieved. in a rare instance the device could break and fall into surgical site or joint space, making it difficult to retrieve. this can potentially cause a surgical delay. it has also been reported that in rare cases the broken blade remained in the patient.
  • Acción
    Smith & Nephew is advising users to immediately discontinue the use of the affected units prior to their quarantine and return.

Device

Beaver 4.0mm Banana Blade
  • Modelo / Serial
    Beaver 4.0mm Banana BladeModel Number: 72203307Various Batch Numbers affectedARTG Number: 140406
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd