Events

Alerte Ou Avis De Sécurité sur Flexible handle (part no. 355.280), used with the Simplified Universal Nail System (SUN) and the Universal Nail System (UNI)

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 Synthes GmbH.

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/2013/059
  • Numéro de l'événement
    CON297581
  • Date
    2013-08-01
  • Date de publication de l'événement
    2013-08-01
  • 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/CON297581?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
    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 ...
  • Modèle / numéro de série
  • Description du dispositif
    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