Events

Retiro De Equipo (Recall) de Greatbatch Medical Offset Reamer Handle (used in total hip arthroplasty as interface between surgical drill and acetabular 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 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-2016-RN-01593-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-12-20
  • 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-01593-1
  • 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
    Greatbatch medical has identified an issue with the 00-7804-080-00 offset reamer handle, as field complaints were reported that the drive chain mechanism seizes during use. the function of the drive chain mechanism is to transmit rotational power from a mechanical drill to an acetabular reamer during a total hip arthroplasty. during seizing, the device is rendered non-functional in the operating room. the risks associated with this failure are: 1. the offset reamer handle seizes and the surgery must be completed with an alternate device, leading to a delay of 30 minutes or greater from the scheduled surgery time. 2. the offset reamer handle seizes and no replacement device is available in the hospital, leading to an interruption and rescheduling of surgery.
  • Acción
    Zimmer is advising that a re-designed Offset Reamer Handle will be available in early 2017 and that customers will be notified once the replacements are available for delivery by Zimmer. In the interim, Zimmer is advising that a Straight Reamer Handle should be always be available and ready for surgical use and/or that a replacement or alternate Offset Reamer Handle, if desired, also be ready for use in a surgical procedure in or near the operating room. A Straight Reamer Handle device is commonly provided as part of the Reamer surgical set. This action has been closed-out on 28/02/2018.

Device

Greatbatch Medical Offset Reamer Handle (used in total hip arthroplasty as interface between surg...
  • Modelo / Serial
    Greatbatch Medical Offset Reamer Handle (used in total hip arthroplasty as interface between surgical drill and acetabular reamer)Part Number: 00-7804-080-00Lot Numbers: 56474941, 56474943, 56474944, 56474947, 56474982, 56474983, 56474990, 56596272, 56596277, 56596292, 56596366, 56596371, 56596428ARTG Number: 266809
  • 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