Events

Rappel de Connecting Screw for Insertion of Dynamic Hip Screw (DHS) Blade(Component of the fixation system implantation kit)

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-00358-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-04-23
  • 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-00358-1
  • 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
    Complaints of the insertion screw breaking inside the blade implant during insertion. when the dhs blade connecting screw breaks inside the implant, it blocks the locking mechanism that is important for rotational stability (ensuring the bone fragments maintain anatomical reduction). in the event that the tip of the connecting screw breaks intraoperatively, the implant locking mechanism (for rotational stability) cannot be secured.If the fragment cannot be retrieved, rotational stability is compromised and the blade needs to be replaced or additional lag screws implanted. this may lead to prolongation of surgical operating time, bone damage and subsequent interventions such as a total hip arthroplasty. if the fragment cannot be retrieved and remains in the dhs blade in the patient, this could lead to an adverse tissue reaction since the connecting screw is not made of implant grade stainless steel.
  • Action
    Johnson & Johnson Medical Pty Limited (JJM) is requesting the customers to check the inventory and quarantine the affected stock prior to returning it to JJM. This action has been closed-out on 24/08/2016.

Device

Connecting Screw for Insertion of Dynamic Hip Screw (DHS) Blade(Component of the fixation system ...
  • Modèle / numéro de série
    Connecting Screw for Insertion of Dynamic Hip Screw (DHS) Blade(Component of the fixation system implantation kit)Part Number: 03.224.007Lot Numbers: 2161305, 2290282, 2523116, 2684005, 7799873, 8296913, 8586241, 9001624, 2243635, 2290283, 2557362, 2733243, 7799873, 8465206, 8694982, 9290024, 2260851, 2512219, 2561953, 2762808, 8037035, 8487190, 8759606, 2260851-I, 2290278, 2513675, 2630618, 2800137, 8117808, 8577396, 8889838, 2260851-L.ARTG number: 153950
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes