Events

Alerte De Sécurité sur Attachment for Acetabular and Medullary Reaming

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Depuy Synthes.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2015-11-12
  • Date de publication de l'événement
    2015-11-12
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151112.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: depuy synthes attachment for acetabular and medullary reaming the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning the attachment for acetabular and medullary reaming, manufactured by depuy synthes. the product is used with the compact air drive ii, an air-driven power tool for use in traumatology, endoprosthetics and spinal column surgery. the affected product number is 511.785 and the affected serial numbers include 16384,16385,16386,16387,16389,16390,16391,16392,16393, 16394,16395,16396,16397,16403,16405 and 16411. according to the manufacturer, the geometrical shape of a subcomponent of this attachment was inadvertently changed. this change allows potential unintended reverse (counter-clockwise) motion if the subcomponent is aligned in a specific orientation when the attachment is connected to the handpiece and both triggers are pressed. this attachment is intended to be used without reverse motion. unintentional activation in reverse could potentially damage flexible drilling or reaming shafts and could potentially cause serious injury to the patient. the manufacturer advises customers to return the affected products. for details, please refer to the tga website:http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2015-rn-01094-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 12 november 2015.

Device

Attachment for Acetabular and Medullary Reaming
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Depuy Synthes Attachment for Acetabular and Medullary Reaming
  • Manufacturer
    Depuy Synthes

Manufacturer

Depuy Synthes