Events

Safety Alert for INSTRUMENTAL FOR HYGIENE SURGERY. Registro ANVISA n ° 80005430185 .. Units affected: see Alert Message published by the company, available at http://portal.anvisa.gov.br/wps/wcm/connect/e1bfcf804cf2a50fbe9ebe551355428f/Mensagem_de_Alerta_.pdf?MOD=AJPERES.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by STRYKER DO BRASIL LTDA..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1189
  • Date
    2012-10-03
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    According to the company, there is a potential danger associated with this product field action: presence of a metal fragment in the internal screwed part of the conical body. There are two predictable sequences of events associated with the presence of a metal fragment: (a) In the first, the fragment falls into the wound and is observed by the surgeon. The dangerous situation is the extra time to remove the fragment. The associated potential risk is an extended surgery time of less than 30 minutes; (b) In the second predictable sequence of events, the fragment falls into the wound and is not observed by the surgeon. The dangerous situation is the fragment being implanted in the patient. The associated potential risk is a localized biological response. As a risk mitigation measure, a field action of the product is being conducted to investigate the presence of the metal fragment. For instructions on completing the Product Field Action Science Form and other information, consult the Company Alert Message at http://portal.anvisa.gov.br/wps/wcm/connect/e1bfcf804cf2a50fbe9ebe551355428f/Alerta_Message_.pdf? MOD = AJPERES #### Update (13/11/2012): According to Sryker, all affected customers have already been informed and no nonconformities have been detected in the products under risk in Brazil. The field action was closed by the company on 11/09/2012.
  • Reason
    Possibility of presence of a metal fragment in the last screwed accessory of the studies of the restoration of modular conical body.
  • Action
    Users are advised to: 1. Instantly locate the objects in this notification; 2. Inspect the devices according to the instructions provided by the manufacturer in the Product Correction Notice attached to this action; 3. Withdraw from operation all devices that fail the inspection, with return delivery to Stryker; 4. Complete the attached Customer Response Form indicating the inspection results for all of the devices in this notification.

Device

INSTRUMENTAL FOR HYGIENE SURGERY. Registro ANVISA n ° 80005430185 .. Units affected: see Alert Me...

Manufacturer

STRYKER DO BRASIL LTDA.
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    ANVSANVISA