Events

Alerta De Seguridad para Drill Bit and Adjustable Drill Stop

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por 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
    2012-09-03
  • Fecha de publicación del evento
    2012-09-03
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120903.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 drill bit and adjustable drill stop it has come to our attention that medical device manufacturer, synthes, has issued a medical device safety alert concerning drill bit 2.5mm complete, 2-flute (part no. 03.613.010); 2.5 mm drill bit, graduated 12mm-26mm adjustable depth (part no. 03.613.011); and adjustable drill stop (part no. 03.613.012). according to the manufacturer, a recall of the vectra system graduated 2.5mm drill bit and the adjustable drill stop has been initiated. although the reported incidence is low, there is the potential for the drill stop to slip on the drill bit resulting in an adverse event. if the drill stop slips on the drill bit, it could result in the penetration of the posterior cortex, dural tear requiring repair, damage to the spinal cord, quadriplegia, and the risk of a potentially life-threatening event. the manufacturer advised users to stop using the affected products and not to utilize self-tapping screws (20-26mm) in the absence of this drill bit assembly. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 3 september 2012.

Device

Drill Bit and Adjustable Drill Stop
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Synthes Drill Bit and Adjustable Drill Stop
  • Manufacturer
    Synthes

Manufacturer

Synthes