Events

Rappel de SynFix-LR Surgical Implant Holder

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Synthes Australia 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-2014-RN-00445-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-04-28
  • 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-00445-1
  • 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 have been received which describe the synfix lr implant holder breaking at the interface between the implant and holder breaking at the interface between the implant and holder. if an unretrieved device fragment remains threaded into the plate, it will not be possible to properly attach the synfix aiming device to the implant (plate). proper attachment of the aiming device to the plate is required for accurate insertion of the four synfix screws into the synfix implant (plate) and vertebral bodies. if the tip of the implant holder should break, the potential exists for an unretrieved device fragment (urdf) to be left in the synfix-lr implant.
  • Action
    DePuy Synthes is updating the SynFix-LR Surgical Technique Guide and notifying their customers that the SynFix Set Case design has been updated to incorporate two additional wrenches to facilitate correct assembly/disassembly and an additional implant holder to facilitate continuation of surgery. Customers are also reminded that an alternative instrument to the implant holder (SQUID, 03.802.121) can be used for the insertion of the implant in suitable cases.

Device

SynFix-LR Surgical Implant Holder
  • Modèle / numéro de série
    SynFix-LR Surgical Implant HolderPart Number: 036.000.915ARTG Number: 153950
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd