Events

Retiro De Equipo (Recall) de Synthes Small Electric Drive Hand Piece (Drill Surgical System)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Synthes 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-2014-RN-01278-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-12-09
  • 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-2014-RN-01278-1
  • 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
    It has been reported that the small electric drive (sed) may experience failure modes such as the device not functioning, the device operating solely in reverse mode, the device not operating in reverse when intended or an unintended start of the device. this may lead to surgical delays in the event the user requires a replacement power tool. an unintended start of the hand piece or wrong mode/direction could cause bone/soft tissue damage, peripheral nerve damage and /or vascular damage because the hand piece has the potential to progress further into the surgical site when the operator is not intending this motion. these injuries may need surgical or medical intervention.
  • Acción
    Affected units are to be quarantined and returned as per the instructions in the Customer Letter. DuPuy Synthes will then provide a replacement at no charge in the form of a Colibri II (532.101) along with an electric adapter (05.001.1058) and a wire driver (532.022) to use instead of the Small Electric Drive. This action has been closed-out on 06/07/2016.

Device

Synthes Small Electric Drive Hand Piece (Drill Surgical System)
  • Modelo / Serial
    Synthes Small Electric Drive Hand Piece (Drill Surgical System)Part Number: 05.001.175 All Lot NumbersARTG Number: 157072
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd