Events

Safety Alert for Engines for Surgical Use

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Synthes Gmbh.

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
    R1607-275
  • Event Number
    2008DM-0003014
  • Date
    2016-07-11
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=133
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer has determined that there is a potential risk to the hummingbird adapter and the small adapter for colibri ii, as well as to the battery unit and the small drive ii battery, by generating excessive internal pressure that may cause the respective products to burst, leading to present possible adverse events on patients or users.

Device

Engines for Surgical Use
  • Model / Serial
    Hummingbird Adapter and the Battery Unit, reference 05.001.108, serial 1215.
  • Product Description
    The engines for surgical use are tools that are intended to generate a continuous movement of their accessories that are cutting tools such as drills, bits and saws in orthopedic and traumatology procedures such as: placement and extraction of prosthesis and osteosynthesis material, intramedullary milling, traumatology in general, foot and hand surgery, craniomaxillofacial surgery, neurosurgery and spinal surgery
  • Manufacturer
    Synthes Gmbh

Manufacturer

Synthes Gmbh