Events

Retiro De Equipo (Recall) de iASSIST Validation Tool

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Zimmer Biomet 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-2017-RN-00397-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-03-31
  • 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-2017-RN-00397-1
  • 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 received an increased number of complaints regarding bent or broken drive pins of the iassist validation tool manufactured with drawing revision m to p. breakage of the drive pin or drive pin head will lead to the parts having to be retrieved and hence, a delay in treatment.Only iassist validation tools with drawing revision m to p drive pins are affected (they have a x cross section instead of circular and the drive pin head has a recess in the enlarged head).
  • Acción
    Zimmer Biomet is advising surgeons that the affected products can continue to be used until replacements are available. In the interim, the Knee Surgical Technique (2-Pod Version) (Ref. 97-9001-004-00 Rev 2) and specifically the warning on pages 36 and 37 regarding applying excessive force, should be followed in order to minimize the chances of bending or breakage during use. In addition, surgeons should inspect affected devices before and immediately after use to confirm that the drive pins are not bent or broken. In the event of breakage, the drive pin head will disassemble and therefore surgeons should ensure that both parts are retrieved from the wound.

Device

iASSIST Validation Tool
  • Modelo / Serial
    iASSIST Validation ToolModel Number: 20-8011-021-00 Rev M-PARTG Number: 205936
  • Manufacturer
    Zimmer Biomet Pty Ltd

Manufacturer

Zimmer Biomet Pty Ltd
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • Comentario del fabricante
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    DHTGA