Events

Retiro De Equipo (Recall) de Optimys Opening Broach Bent (Reusable surgical instrument used for opening the medullary canal)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Mathys Orthopaedics 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-2013-RN-01020-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-10-17
  • 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-2013-RN-01020-1
  • 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
    Mathys ltd bettlach has been notified of an incident in switzerland where the optimys opening broach broke intraoperatively and the fragment was left in the bone. in the course of the investigations, it became apparent that the opening broach bent may exhibit surface defects in the hewn portion which may favour breakage in case of non-compliant usage.
  • Acción
    Replacement products made of more suitable material are being manufactured and will be provided to customers as soon as they become available. In the interim, customers are reminded on the correct usage of the device according to the surgical technique.

Device

Optimys Opening Broach Bent (Reusable surgical instrument used for opening the medullary canal)
  • Modelo / Serial
    Optimys Opening Broach Bent (Reusable surgical instrument used for opening the medullary canal)Article Number: 51.34.0079Lot Number: 6054883ARTG Number: 184413
  • Manufacturer
    Mathys Orthopaedics Pty Ltd

Manufacturer

Mathys Orthopaedics Pty Ltd