Events

Rappel de Reamer/Irrigator/Aspirator (RIA)(Medullary canal orthopaedic reamer, flexible)

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-00618-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-07-17
  • 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-00618-1
  • 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
    Depuysynthes reported that the ria drive shaft, tube assembly, and reamer head have the potential to break when incorrectly assembled or used improperly as follows: - failure to fully engage the reamer to shaft at assembly prior to surgery. incorrect assembly creates a reduced reamer/shaft contact surface area, in which excess rotational forces could cause breakage- use of ria drive shafts after the flats have become worn and rounded - use of any excess force beyond design limit - use with an incompatible power tool. precautionary statements are being added to the reamer / irrigator / aspirator (ria) surgical technique guide.
  • Action
    DePuySynthes is requesting the customers to download the updated Surgical Technique Guide (036.000.553). from Synthes website at:- http://syntheskyo.com/global_trauma_kyo/home/home.htm or contact their DePuy Synthes Representative for a hardcopy. This action has been closed-out on 05/12/2016.

Device

Reamer/Irrigator/Aspirator (RIA)(Medullary canal orthopaedic reamer, flexible)

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes