Events

Safety Alert Or Field Safety Notices for Synthes trauma external fixation system (small, medium, distraction osteogenesis (DO) ring and large)

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by DePuy Synthes.

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
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2014/030
  • Event Number
    CON437740
  • Date
    2014-07-23
  • Event Date Posted
    2014-07-23
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON437740?tabName=allTabs
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
  • Reason
    The instructions for use have changed. these devices are now identified as being ‘mr-conditional’. this places additional restrictions on patient positioning. failure to follow the updated instructions may result in patient harm. depuy synthes issued a second field safety notice (fsn) dated 4 july 2014, which is an extension to their original field safety notice (fsn) dated 14 april 2014.
  • Action
    Identify affected devices using the information provided in the manufacturer’s FSNs dated 14 April  2014 and 4 July 2014 Download or request from the manufacturer a copy of the new instructions for use. Ensure that relevant staff are made aware of the changes. Ensure that all DePuy Synthes external fixation products etched ‘MR-Safe’ are considered as MR-Conditional and used in accordance with the updated MR-Conditional labelling. Return the manufacturer’s verification form. Medical directors Orthopaedic departments Orthopaedic surgeons Staff involved in the management of patients with external fixation system MR radiographers Radiologists

Device

Synthes trauma external fixation system (small, medium, distraction osteogenesis (DO) ring and la...
  • Model / Serial
  • Product Description
    External fixators. Synthes trauma external fixation system (small, medium, distraction osteogenesis (DO) ring and large) Specific part numbers affected.
  • Manufacturer
    DePuy Synthes

Manufacturer

DePuy Synthes