Events

Rappel de Synthes Small Electric Drive Hand Piece (Drill Surgical System)

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-01278-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-12-09
  • 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-01278-1
  • 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
    It has been reported that the small electric drive (sed) may experience failure modes such as the device not functioning, the device operating solely in reverse mode, the device not operating in reverse when intended or an unintended start of the device. this may lead to surgical delays in the event the user requires a replacement power tool. an unintended start of the hand piece or wrong mode/direction could cause bone/soft tissue damage, peripheral nerve damage and /or vascular damage because the hand piece has the potential to progress further into the surgical site when the operator is not intending this motion. these injuries may need surgical or medical intervention.
  • Action
    Affected units are to be quarantined and returned as per the instructions in the Customer Letter. DuPuy Synthes will then provide a replacement at no charge in the form of a Colibri II (532.101) along with an electric adapter (05.001.1058) and a wire driver (532.022) to use instead of the Small Electric Drive. This action has been closed-out on 06/07/2016.

Device

Synthes Small Electric Drive Hand Piece (Drill Surgical System)
  • Modèle / numéro de série
    Synthes Small Electric Drive Hand Piece (Drill Surgical System)Part Number: 05.001.175 All Lot NumbersARTG Number: 157072
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd