Events

Safety Alert for motor for orthopedic surgery

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Stryker Instruments || Stryker Ireland-Instruments.

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
    R1502-70
  • Event Number
    2008DM-0002802
  • Date
    2015-02-17
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=185
  • 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 reports that the laser welder could have failed in the continuous line union for the housings referenced, this fault in the welding could lead to the separation of the two housings sections causing the loss of mechanical connection between the handpiece and the battery, leading to generate possible adverse events on the patient and the prolongation of surgical time.

Device

motor for orthopedic surgery
  • Model / Serial
    SYSTEM 6, model 6126-120-000, lots 13205, 13209, 13210 and 13212.
  • Product Description
    These equipments are destined to generate the controlled movement of its accessories and associated instruments in order to facilitate orthopedic procedures by means of power, speed in circular, rotating and oscillating movements controlled among others for efficient cuts and perforations in bone as well as for the placement and extraction of the materialatornillable of the osteosynthesis material.
  • Manufacturer
    Stryker Instruments || Stryker Ireland-Instruments

Manufacturer

Stryker Instruments || Stryker Ireland-Instruments
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    NIDFSINVIMA