Events

Rappel de DePuy Synthes Impactor for PFNA 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 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-2016-RN-01638-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-12-15
  • 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-01638-1
  • 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
    Depuy synthes trauma has received product complaints for breakage in the pfna blade impactor, where the handle detached from the shaft of the instrument. it has been identified that a laser weld breakage, partial or complete, can occur in the pfna blade impactor where the handle detaches from the internal shaft of the instrument.In the event that the laser welding of the handle cracks, the handle may loosen or separate from the instrument. if the issue is detected during use, a marginal surgical delay may occur if the handle cracks, loosens, or separates. infection could potentially result if the handle is loosened from the shaft and allows body fluids (i.E. blood, bony debris) to enter the interior of the impactor’s handle.
  • Action
    Customers are advised to immediately quarantine the product and return it to JJM. If they have any questions about alternative devices, they are advised to contact DePuy Synthes Trauma.

Device

DePuy Synthes Impactor for PFNA Blade

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes