Events

Field Safety Notices about Cortex Screw fl 4.5mm

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Synthes GmbH.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2016-04-26
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    Two lots of 4.5mm cortex screws, length 20mm, may contain a 4.5mm cortex screw that is 22mm in length. the screws are both etched and labeled with the above 20mm part numbers. potential hazard: the outside package labeling and the etching on the product would indicate to the user that the screw is 2mm shorter than its actual length of 22mm. for non—sterile products, there is an opportunity to detect the issue if the screw is measured prior to placement into the tray/module. once the screw enters the operating room, either sterile or unsterile, the user should measure the screw prior to insertion. if detected at this time it may result in a surgical delay while a replacement is obtained or if the surgeon inserts the screw, determines it was the wrong length on radiographic imaging, and then removes and replaces it.

Device

Cortex Screw fl 4.5mm

Manufacturer

Synthes GmbH