Events

Safety Alert for Osteosynthesis Material for Extremities

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
    R1607-291
  • Event Number
    2011DM-0007213
  • Date
    2016-07-22
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=131
  • 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 states that the batches affected in their yellow guide sheath could have been manufactured with a slightly larger diameter than the specified one, which could prevent the sheath from passing correctly through the brazodirectional tfna, leading to the occurrence of adverse events on patients.

Device

Osteosynthesis Material for Extremities
  • Model / Serial
    GUIDE SLEEVE, reference 03.037.017, specific lots.
  • Product Description
    The osteosynthesis material for SYNTHES extremities are nonabsorbable implants designed to help immobilization, stable fixation and stabilization of bone fragments during the treatment of fractures, trauma, reconstruction and bone deformities, restoration of anatomical features and allowing an accurate approximation. There are different types of osteosynthesis implants corresponding to the bones of the extremities of the body, for example: femur, tibia, ulna, radius, humerus, hand, foot, etc. These osteosynthesis implants can be used or not in conjunction with the other osteosynthesis implants to immobilize the affected bone and fix in such a way to induce bone growth and scar healing. The intramedullary nails together with the debloqueo screws are used for the osteosynthesis of big bones like the femur, the tibia and the humerus. SYNTHES deosteosynthesis implants are classified into systems according to their dimensions and shapes that make them more suitable for different parts of the extremities of the body, their traumas and pathologies. It is noted that these implants can be combined with the original parts of the same system.
  • Manufacturer
    Synthes Gmbh

Manufacturer

Synthes Gmbh