Events

Rappel de Beaver 4.0mm Banana Blade

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Smith & Nephew 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-00093-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-01-22
  • 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-00093-1
  • 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
    A number of customer complaints have been received indicating that during arthroscopic hip surgery the blades are experiencing brittle fracture.In the event the instrument breaks, the failure is visually obvious to the user and the broken blade can be retrieved. in a rare instance the device could break and fall into surgical site or joint space, making it difficult to retrieve. this can potentially cause a surgical delay. it has also been reported that in rare cases the broken blade remained in the patient.
  • Action
    Smith & Nephew is advising users to immediately discontinue the use of the affected units prior to their quarantine and return.

Device

Beaver 4.0mm Banana Blade
  • Modèle / numéro de série
    Beaver 4.0mm Banana BladeModel Number: 72203307Various Batch Numbers affectedARTG Number: 140406
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd