Events

Retiro De Equipo (Recall) de Reflection Deadblow Mallet

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Smith & Nephew 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-00301-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-03-01
  • 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-00301-1
  • 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
    Smith & nephew has received a small number of complaints reporting cracks in the welds located on the head of the mallet, which is filled with lead beads. in the reported cases some of the lead beads and particles escaped from the mallet into the surgical wound. as these failures occurred intra-operatively and appropriate actions were taken to remove the lead beads from the wound during surgery, no further adverse effects were reported. smith & nephew is recalling the mallets as the risk of lead escaping from the mallet and the potential adverse effects associated with lead exposure were previously unidentified risks. based on the low occurrence (0.03%) of the worst case failure mode defined above and the high detectability should any lead beads escape into the surgical wound, no proactive follow-up is recommended.
  • Acción
    Smith & Nephew are advising customers to immediately locate and quarantine affected devices. Smith & Nephew will arrange for the return of the devices and the provision of unaffected replacement mallets.

Device

Reflection Deadblow Mallet
  • Modelo / Serial
    Reflection Deadblow MalletModel Number: 71362106All Batch NumbersARTG Number: 104373
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd