Events

Retiro De Equipo (Recall) de Hallu-Fix Drill, Diameter 1.9mm, supplied in Hallu-Fix system instrumentation set (used for orthopaedic foot surgery)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Integra Neurosciences 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-01387-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-10-20
  • 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-01387-1
  • 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 manufacturer has identified a defect in lot fe58 of hallu-fix drill diameter 1.9mm, where the drill may not be sharp enough to prepare screw holes. the defect can be easily recognised during use and an increase of surgery time may be observed while another similar drill is found to prepare the screw holes. if an affected drill is used, the defect can contribute to an increase of surgery time of approximately 10 minutes and require a higher pressure on the drill. this pressure may cause minimal transient tissue damage and difficulties to achieve the surgery. to date no injury or adverse event has been reported.
  • Acción
    Integra Neurosciences is advising customers to review their inventory for the affected drill and stop using the affected drill immediately. Integra will provide directions for return of the product and will replace affected stock. This action has been closed-out on 18/05/2017.

Device

Hallu-Fix Drill, Diameter 1.9mm, supplied in Hallu-Fix system instrumentation set (used for ortho...
  • Modelo / Serial
    Hallu-Fix Drill, Diameter 1.9mm, supplied in Hallu-Fix system instrumentation set (used for orthopaedic foot surgery)Catalogue Number for Drill: 119618ND Lot Number: FE58 ARTG Number: 174104
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd