Events

Safety Alert for INTRODUCTION GUIDELINES USED IN ORTHOPEDICS AND TRAUMATOLOGY FOR THE GUIDED CANULATION OF SCREWS SYSTEMS

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by (1) B BRAUN MEDICAL LTDA.; (2) BIOMET MERCK LTDA.; (3) DE PUY INTERNATIONAL LTDA.; (4) SMITH & NEPHEW PLC; (5) STRATEC MEDICAL LTDA.; (6) STRYKER HOWMEDICA OSTEONICS DIV STRYKER CORP.; (7) ZIMMER 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
    46
  • Date
    2001-06-01
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    Medical devices agency, mda / uk, laid an alert due to the report of a fatal incident, in which a canulated drill went into the introduction guide and advanced about the pelvis reaching the ilíaca veia. mda alert on the risk of advancing guidelines for underlying tissues during procedures involving insertion, scratching, inserting screws and screwing through guides with canulated instruments.
  • Action
    MEDICAL DEVICES AGENCY, MDA / UK, RECOMMENDS THAT PROFESSIONALS: (1) VERIFY THE POSITION OF THE INTRODUCTION GUIDELINES WITH IMAGE INTENSIFIER (FLUOROSCOPY) FREQUENTLY TO AVOID ADVANCEMENT AND PENETRATION IN THE ADJACENT FABRICS. (2) CLEANING THE CANULATED INSTRUMENTS DURING OPERATION TO AVOID BONE PARTICULATE ACULVULATION IN THE CELL. FOR TECHNICAL INVESTIGATIONS, MEDICAL DEVICES AGENCY, MDA / UK, HAS PLACED TWO EXPERTS IN DISPOSAL, DRS. J. COOKE OR DR. J. SHAW (FAX: 0021-44-207-972-8106, PHONE 0021-44-207-972-8267 OR 8343 OR MAIL, HANNIBAL HOUSE, ELEPHANT AND CASTLE, LONDON SE1 6TQ, ENGLAND). FOR CLINICAL RESEARCH, DR. J. HOPPER (FAX: 0021-44-207-972-8103, PHONE 0021-44-207-972-8126 OR BY MAIL, HANNIBAL HOUSE, ELEPHANT AND CASTLE, LONDON SE1 6TQ, ENGLAND). FOR ALL INVESTIGATIONS, CIT THE REFERENCE NO. 20000519011-8.

Device

INTRODUCTION GUIDELINES USED IN ORTHOPEDICS AND TRAUMATOLOGY FOR THE GUIDED CANULATION OF SCREWS ...

Manufacturer

(1) B BRAUN MEDICAL LTDA.; (2) BIOMET MERCK LTDA.; (3) DE PUY INTERNATIONAL LTDA.; (4) SMITH & NE...
  • Source
    ANVSANVISA