Events

Alerta De Seguridad para Attachment for Acetabular and Medullary Reaming

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Depuy Synthes.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2015-11-12
  • Fecha de publicación del evento
    2015-11-12
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151112.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: depuy synthes attachment for acetabular and medullary reaming the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning the attachment for acetabular and medullary reaming, manufactured by depuy synthes. the product is used with the compact air drive ii, an air-driven power tool for use in traumatology, endoprosthetics and spinal column surgery. the affected product number is 511.785 and the affected serial numbers include 16384,16385,16386,16387,16389,16390,16391,16392,16393, 16394,16395,16396,16397,16403,16405 and 16411. according to the manufacturer, the geometrical shape of a subcomponent of this attachment was inadvertently changed. this change allows potential unintended reverse (counter-clockwise) motion if the subcomponent is aligned in a specific orientation when the attachment is connected to the handpiece and both triggers are pressed. this attachment is intended to be used without reverse motion. unintentional activation in reverse could potentially damage flexible drilling or reaming shafts and could potentially cause serious injury to the patient. the manufacturer advises customers to return the affected products. for details, please refer to the tga website:http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2015-rn-01094-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 12 november 2015.

Device

Attachment for Acetabular and Medullary Reaming
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Depuy Synthes Attachment for Acetabular and Medullary Reaming
  • Manufacturer
    Depuy Synthes

Manufacturer

Depuy Synthes