Events

Rappel de Ankle Arthrodesis Nail 611AFN Drill Bit

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Tornier Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2017-RN-00680-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-06-06
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00680-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    Despite being guided by drill reference mju775, cases of drill breakage during surgery have been received by wright medical australia. this issue has been replicated by the manufacturer in internal tests. breakage of the tip of the drill during use may lead to the need to remove debris and a delay in surgery.
  • Action
    Wright Medical is advising users that in order to optimize the drilling technique, there will be a modification to the cutting edge of the drill. Users will be contacted for the return and exchange when replacements become available (from November 2017). In the interim, users are advised to apply the drilling force in the axis of the drill (as illustrated in the recall notification).

Device

Ankle Arthrodesis Nail 611AFN Drill Bit
  • Modèle / numéro de série
    Ankle Arthrodesis Nail 611AFNDrill Bit Model Number: MJU777Lot Numbers 11D463 and 12E794ARTG Number: 112287
  • Manufacturer
    Tornier Pty Ltd

Manufacturer

Tornier Pty Ltd