Events

Rappel de Hallu-Fix Drill, Diameter 1.9mm, supplied in Hallu-Fix system instrumentation set (used for orthopaedic foot surgery)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Integra Neurosciences 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-2016-RN-01387-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-10-20
  • 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-2016-RN-01387-1
  • 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
    The manufacturer has identified a defect in lot fe58 of hallu-fix drill diameter 1.9mm, where the drill may not be sharp enough to prepare screw holes. the defect can be easily recognised during use and an increase of surgery time may be observed while another similar drill is found to prepare the screw holes. if an affected drill is used, the defect can contribute to an increase of surgery time of approximately 10 minutes and require a higher pressure on the drill. this pressure may cause minimal transient tissue damage and difficulties to achieve the surgery. to date no injury or adverse event has been reported.
  • Action
    Integra Neurosciences is advising customers to review their inventory for the affected drill and stop using the affected drill immediately. Integra will provide directions for return of the product and will replace affected stock. This action has been closed-out on 18/05/2017.

Device

Hallu-Fix Drill, Diameter 1.9mm, supplied in Hallu-Fix system instrumentation set (used for ortho...
  • Modèle / numéro de série
    Hallu-Fix Drill, Diameter 1.9mm, supplied in Hallu-Fix system instrumentation set (used for orthopaedic foot surgery)Catalogue Number for Drill: 119618ND Lot Number: FE58 ARTG Number: 174104
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd