Events

Retiro De Equipo (Recall) de Apex 10mm reamer

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Global Orthopaedic Technology 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-2015-RN-00419-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-05-18
  • 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-2015-RN-00419-1
  • 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
    Sequential reaming of the patient's femur was being carried out during a total hip replacement(thr) procedure. following the use of the 8mm reamer, the 10mm reamer was introduced. during reaming the bottom of the reamer broke off while lodged in the patients femur, approximately 40mm below the resection level. a distal window was cut into the femur, and the broken section of the reamer removed. under torque the reamer broke at a weld joint. the joint was insufficiently strong.This action is undertaken prior to notifying the tga.
  • Acción
    Global Orthopaedics Technology has retrieved, quarantined and returnign all affected reamers to the manufacturer. The manufacturer, Omni Life Sciences, has obsoleted the design used for the affected reamers.

Device

Apex 10mm reamer
  • Modelo / Serial
    Apex 10mm reamer ARTG Number: 183711CER-227: 16-May-2011- 8.5mm REAMER Lot L0805CER-257: 10-Aug-2011 - 16mm REAMER Lot L0805CER-358: 18-0ct -2012 - 10mm REAMER Lot L0805
  • Manufacturer
    Global Orthopaedic Technology Pty Ltd

Manufacturer

Global Orthopaedic Technology Pty Ltd