Events

Rappel de Synthes Connection Screw for Insertion of Dynamic Hip Screw (DHS) Blade

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Synthes GmbH.

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
    18463
  • Date de mise en oeuvre de l'événement
    2015-11-09
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Johnson & Johnson (NZ) Limited, 13a Gabador Place, Mt Wellington, AUCKLAND
  • 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
    Product to be returned to supplier

Device

Synthes Connection Screw for Insertion of Dynamic Hip Screw (DHS) Blade
  • Modèle / numéro de série
    Model: Part Number: 03.224.007, Affected: 32 lots
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH