Events

Rappel de TFN-ADVANCED Proximal Femoral Nailing System (TFNA)

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

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-2015-RN-00372-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-05-05
  • 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-2015-RN-00372-1
  • 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
    Johnson & johnson is initiating a recall for product correction for the depuy synthes tfn-advanced proximal femoral nailing system (tfna). the tfna system is intended for treatment of proximal femoral fractures.There is the potential that the tfna nails received before march 31, 2015 from the affected lots were assembled with a locking mechanism too close to the top of the nail. this problem was due to human error during assembly of the device with the manufacturer and no design changes are required.Therefore locking mechanism could:· prevent the connecting screw from fully tightening the insertion handle to the nail resulting in a loose or toggling nail in the insertion handle, or· cause the bottom of the connecting screw to tighten against the top of the locking mechanism preventing advancement of the locking mechanism.The above may lead to delays in surgery with the potential for complications associated with prolonged anaesthesia.
  • Action
    A workaround is being provided for users via the customer letter. This action has been closed-out on 08/08/2016.

Device

TFN-ADVANCED Proximal Femoral Nailing System (TFNA)

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes