Alerta De Seguridad para Trade name: SURGICAL INSTRUMENTS. Technical Name: INSTRUMENTAL NON-ARTICULATED NON-CUTTING. ANVISA registration number: 80145901733. Risk class: I - LOW RISK. Affected Model: Pin Pullers and Screws. Serial numbers affected: "Cod .: 03.401.072 || Lot 10-2637 .. Cod .: 03.401.077 || Lot 10-4566."

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda.; 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
  • ID del evento
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notas adicionales en la data
    The company directs the following actions to be taken: • Read the instructions listed in the notification. • Resign notification to all persons who need to be informed at their premises. • If any of the affected persons have transferred to another facility, contact this facility. • Archive a copy of this notification. • Review, complete, sign, and return the response attached to page 3 of the letter of intent to the DePuy Synthes seller. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (EA) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System (http: //portal.anvisa / notivisa). To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 03/28/2018 - Date of notification notice to Anvisa: 04/11/2018 "The company that owns the affected product is responsible for contacting its customers in a timely manner in order to guarantee the effectiveness of the Field Action underway.We highlight the joint responsibility of the chain of distribution and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art. 2. A holder of a product registration for health is the owner of the registration / registration of health product with Anvisa. , as well as the other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the products for health to the consumer Article 12 Distributors of health products shall forward the distribution map and other information required for the notification and execution of field actions to the registration holder in a timely manner. (...) ""
  • Causa
    The company informs that there is a possibility of breaking the union screw (code 03.401.077) of the pin extractor (code 03.401.072). this break can occur during the third step, "head / eccentric removal and humeral pin extraction" as shown in the "epca review kit" customer communication letter.
  • Acción
    Action field code: 1124235, triggered under the responsibility of the company Johnson & Johnson of Brazil Ind. And Com. De Prod. for Health Ltda. Field Security Notification - Communication to Customers