Events

Alerta De Seguridad para Bone Screws

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
    2013-08-21
  • Fecha de publicación del evento
    2013-08-21
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130821.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 bone screws medical device manufacturer, synthes, has initiated a product recall of certain bone screws. the affected part numbers are 04.019.030; 04.019.038; 04.019.040; 04.019.042; 04.019.046; 04.019.054; 412.105; 412.118; 413.012; 413.016; 413.018; 413.022; 413.024; 413.026; 413.028; 413.040s; 413.044s; 413.052; 413.070s; 413.314; 413.326; 413.330; 413.330s; 413.332; 413.332s; 413.334; 413.336; 413.338; 413.338s; 413.340; 413.340s; 413.342; 413.344; 413.350s; 413.355s; 413.360; 413.360s; 413.365; 413.375; 413.380; 413.385; 413.414; 413.465 and 422.396-us. synthes received a complaint by a surgeon that a multiloc screw with a deformed cross-hole was identified in the loan office. the root cause is related to an employee failed to follow established processes. the manufacturer explains that the presence of a screw that is out of specification may be detected prior to insertion. in this situation it is likely that the surgical delay would be minimal while an alternative screw is located and inserted. the screw may also be difficult to insert and/remove due to the non-conformance. if the screw was inserted and the non-conformance was detected after implantation, a surgical delay may result, during removal, exposing the patient to increased amounts of anesthesia and iv fluids. one the other hand, if the non-conforming screw is not detected by the surgeon and the index procedure is completed, there is the potential that the screw will not perform as anticipated during the post-operative recovery period. the non-conforming screw has a smaller outer diameter, hence there is an increased risk of screw loosening and backout in this scenario. this can result in prolonged healing, pain, and the need for an additional surgical intervention. permanent impairment is not anticipated. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 21 august 2013.

Device

Bone Screws
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Synthes Bone Screws
  • Manufacturer
    Synthes

Manufacturer

Synthes