Events

Retiro De Equipo (Recall) de SynFix-LR Surgical Implant Holder

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-00445-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-04-28
  • 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-00445-1
  • 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
    Complaints have been received which describe the synfix lr implant holder breaking at the interface between the implant and holder breaking at the interface between the implant and holder. if an unretrieved device fragment remains threaded into the plate, it will not be possible to properly attach the synfix aiming device to the implant (plate). proper attachment of the aiming device to the plate is required for accurate insertion of the four synfix screws into the synfix implant (plate) and vertebral bodies. if the tip of the implant holder should break, the potential exists for an unretrieved device fragment (urdf) to be left in the synfix-lr implant.
  • Acción
    DePuy Synthes is updating the SynFix-LR Surgical Technique Guide and notifying their customers that the SynFix Set Case design has been updated to incorporate two additional wrenches to facilitate correct assembly/disassembly and an additional implant holder to facilitate continuation of surgery. Customers are also reminded that an alternative instrument to the implant holder (SQUID, 03.802.121) can be used for the insertion of the implant in suitable cases.

Device

SynFix-LR Surgical Implant Holder
  • Modelo / Serial
    SynFix-LR Surgical Implant HolderPart Number: 036.000.915ARTG Number: 153950
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd