Events

Safety Alert for Product name: Instrumental Reflection Technical name: Instrumental Kit ANVISA Registration Number: 80804050103 Hazard Class: I Affected Model: 71362106 - Reflection Guide Serial numbers affected: 15FM16705 / 15JM05524 / 15JM15006 / 15DM20374 / 15JM05522 / 15JM14855

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Smith & Nephew Comércio de Produtos Médicos Ltda.; Smith & Nephew, Inc. .

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
    2131
  • Date
    2016-12-12
  • 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
    1. Locate and immediately quarantine the unused affected devices. 2. Return the quarantined product to Smith & Nephew's national agency or distributor. 3. Fill out the return slip and fax it to Smith & Nephew's national agency or distributor. 4. Ensure that this safety information is passed on to all who need to be aware of it within your institution. 5. Observe this notice, as well as the resulting action, until the corrective security action is completed to ensure its effectiveness.
  • Reason
    The standard surgical instrumentation, suitable for use in hip replacement surgeries for general impact operations of mandrels and hip implants. some complaints were received regarding the existence of cracks in the weld of the hammer's head. in a small number of reported cases, the cracks in the solder resulted in the release of some lead beads from the hammer's head. in reported cases, some of the lead particles and beads passed from the hammer to the surgical wound. as these failures occurred intraoperatively and adequate measures were taken to remove lead beads from the wound during surgery, no further adverse effects were reported. smith & nephew is voluntarily recalling as the risk of hammer lead release and the possible adverse effects associated with lead exposure were previously unidentified risks. based on the low occurrence (0.03%) of the worst case failure mode defined above, and the high detection capacity of lead spheres from the lead to the surgical wound, no proactive monitoring is recommended.
  • Action
    Field Action Code 003/2016 triggered under the responsibility of Smith & Nephew Comércio de Produtos Médicos Ltda. Company will collect for further destruction.

Device

Product name: Instrumental Reflection Technical name: Instrumental Kit ANVISA Registration Number...

Manufacturer

Smith & Nephew Comércio de Produtos Médicos Ltda.; Smith & Nephew, Inc.