Events

Alerta De Seguridad para TFNA Helical-Blade Impactor

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
    2015-06-19
  • Fecha de publicación del evento
    2015-06-19
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150619a.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 tfna helical-blade impactor medical device manufacturer, synthes gmbh, has issued a medical device safety alert concerning its tfna helical-blade impactor [part number: 03.037.024; lot number: t102762]. the manufacturer has initiated a voluntary medical device recall of one lot of the tfna helical-blade impactor of the tfn-advancedtm proximal femoral nailing system. the tfna system is intended for treatment of proximal femoral fractures. the height of one of the three guiding pins of the tfna helical-blade impactor may potentially be oversized. if the guiding pin were to be oversized, the tfna helical-blade impactor (part number 03.037.024) would not be able to pass through the guide sleeve (part number 03.037.017). if the tfna helical-blade impactor is not able to pass through the guide sleeve, there is the potential for surgical delay while an alternative trauma set is located to complete the procedure. 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 19 june 2015.

Device

TFNA Helical-Blade Impactor
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Synthes GmbH TFNA Helical-Blade Impactor
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH