Events

Alerte Ou Avis De Sécurité sur Synthes trauma external fixation system (small, medium, distraction osteogenesis (DO) ring and large)

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par DePuy Synthes.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • ID de l'événement
    MDA/2014/030
  • Numéro de l'événement
    CON437740
  • Date
    2014-07-23
  • Date de publication de l'événement
    2014-07-23
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON437740?tabName=allTabs
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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...
  • Modèle / numéro de série
  • Description du dispositif
    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