Events

Alerte De Sécurité sur Drill Bit and Adjustable Drill Stop

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par 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
    2012-09-03
  • Date de publication de l'événement
    2012-09-03
  • 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_20120903.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: synthes drill bit and adjustable drill stop it has come to our attention that medical device manufacturer, synthes, has issued a medical device safety alert concerning drill bit 2.5mm complete, 2-flute (part no. 03.613.010); 2.5 mm drill bit, graduated 12mm-26mm adjustable depth (part no. 03.613.011); and adjustable drill stop (part no. 03.613.012). according to the manufacturer, a recall of the vectra system graduated 2.5mm drill bit and the adjustable drill stop has been initiated. although the reported incidence is low, there is the potential for the drill stop to slip on the drill bit resulting in an adverse event. if the drill stop slips on the drill bit, it could result in the penetration of the posterior cortex, dural tear requiring repair, damage to the spinal cord, quadriplegia, and the risk of a potentially life-threatening event. the manufacturer advised users to stop using the affected products and not to utilize self-tapping screws (20-26mm) in the absence of this drill bit assembly. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 3 september 2012.

Device

Drill Bit and Adjustable Drill Stop
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Synthes Drill Bit and Adjustable Drill Stop
  • Manufacturer
    Synthes

Manufacturer

Synthes