Events

Alerta De Seguridad para TFN-ADVANCED Proximal Femoral Nailing System

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

¿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
    2015-04-27
  • Fecha de publicación del evento
    2015-04-27
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150427a.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: synthes gmbh tfn-advanced proximal femoral nailing system medical device manufacturer, synthes gmbh, has issued a medical device safety alert concerning its tfn-advanced proximal femoral nailing system (tfna). according to the manufacturer, there is the potential that the tfna nails received before march 31, 2015 from the affected lots were assembled with a locking mechanism too close to the top of the nail. the locking mechanism could:- prevent the connecting screw from fully tightening the insertion handle to the nail resulting in a loose or toggling nail in the insertion handle, or  cause the bottom of the connecting screw to tighten against the top of the locking mechanism preventing advancement of the locking mechanism. if the affected nails were inadequately assembled, there is the potential of surgical delay. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 27 april 2015.

Device

TFN-ADVANCED Proximal Femoral Nailing System
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Synthes GmbH TFN-ADVANCED Proximal Femoral Nailing System
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH