Events

Safety Alert Or Field Safety Notices for Flexible handle (part no. 355.280), used with the Simplified Universal Nail System (SUN) and the Universal Nail System (UNI)

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 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
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2013/059
  • Event Number
    CON297581
  • Date
    2013-08-01
  • Event Date Posted
    2013-08-01
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON297581?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
    Due to the design of the instrument, the device may not be adequately cleaned. this could result in a risk of infection to the patient. the manufacturer has redesigned the affected part and issued a field safety notice advising on the replacement and return of the affected device.
  • Action
    Identify and quarantine the affected device. Contact the manufacturer for a replacement device. Until replacement devices are received, use an alternative fixation method for insertion procedures and postpone removal procedures except where there is no alternative. Decontamination units e.g. sterilisation departments Medical directors Orthopaedic departments Orthopaedic surgeons Staff involved in the management of patients implanted with nailing systems Theatre managers Theatre staff

Device

Flexible handle (part no. 355.280), used with the Simplified Universal Nail System (SUN) and the ...
  • Model / Serial
  • Product Description
    Orthopaedic instrument. Flexible handle (part no. 355.280), used with the Simplified Universal Nail System (SUN) and the Universal Nail System (UNI). The flexible handle is used during the insertion of the universal tibial nail, and femoral universal nail and the extraction of all universal nails. All devices of the old design, where the handles are perpendicular to the threaded section, are affected by this recall - see figures below for a visual comparison of the old and new design. The affected flexible handle (part no. 355.280) is always attached to the hammer guide (part no. 355.220).
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH