Events

Rappel de DePuy Synthes ATTUNE Intuition Distal Femoral Jig

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 Australia.

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-2014-RN-01190-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-11-18
  • 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-2014-RN-01190-1
  • 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 medical pty ltd (jjm) has identified that the metal pin bushing was incorrectly assembled during the manufacturing process in some instruments. jjm has also determined that if the metal pin bushing is overloaded by over tightening, there is the potential for partial or full displacement of the metal pin bushing along with fracture of the plastic around the metal pin bushing. if the plastic around the metal pin bushing fractures, there is the potential for fragments of the fractured plastic to be left in the patient. this displacement is potentially caused by excessive loading applied during pinning of the jig to the distal femoral condyles. the use of the pins in the distal resection plate is optional and the complaint rate of the bushings partially or fully displacing is 0.018%.
  • Action
    JJM staff will contact hospitals to assist with the inspection and swap of potentially affected units and informing the surgeons that jigs may continue to be used at the discretion of the medical professional following the instructions provided in the letter. JJM is also providing surgeons with a Safety Alert notification to ensure the correct load is applied during pinning of the jig to the distal femoral condyles. This action has been closed-out on 14/07/2016.

Device

DePuy Synthes ATTUNE Intuition Distal Femoral Jig

Manufacturer

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia