Events

Alerte De Sécurité sur TFNA Helical-Blade Impactor

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Synthes GmbH.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2015-06-19
  • Date de publication de l'événement
    2015-06-19
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150619a.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: synthes gmbh tfna helical-blade impactor medical device manufacturer, synthes gmbh, has issued a medical device safety alert concerning its tfna helical-blade impactor [part number: 03.037.024; lot number: t102762]. the manufacturer has initiated a voluntary medical device recall of one lot of the tfna helical-blade impactor of the tfn-advancedtm proximal femoral nailing system. the tfna system is intended for treatment of proximal femoral fractures. the height of one of the three guiding pins of the tfna helical-blade impactor may potentially be oversized. if the guiding pin were to be oversized, the tfna helical-blade impactor (part number 03.037.024) would not be able to pass through the guide sleeve (part number 03.037.017). if the tfna helical-blade impactor is not able to pass through the guide sleeve, there is the potential for surgical delay while an alternative trauma set is located to complete the procedure. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 june 2015.

Device

TFNA Helical-Blade Impactor
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Synthes GmbH TFNA Helical-Blade Impactor
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH