Events

Alerte De Sécurité sur ATTUNE INTUITION Tibial Articulation Surface Instruments

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
    2015-06-19
  • Date de publication de l'événement
    2015-06-19
  • 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_20150619b.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 attune intuition tibial articulation surface instruments medical device manufacturer, depuy synthes, has issued a medical device safety alert concerning all lots of the attune intuition tibial articulation surface instruments used in trialing with the attune knee system. according to the safety alert, the balseal, which is a small wire spring coil located on the post feature of the articulation surface instruments, has the potential to become damaged and disassociate (come off). the balseal is constructed from implant grade stainless steel. if the balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation. damage to the balseal is potentially caused by: inserting the tibial trial extractor or other instrument between the articulation surface trial and shim trial, causing contact with the balseal during intraoperative trialing or back table disassembly. cleaning that deviates from the instructions for use (ifu) procedures. to reduce the possibility of leaving a disassociated balseal in a patient, the manufacturer advises users to follow the ifu, which include inspecting the attune articulation surface instruments before, during and after use, to ensure that the balseals are not damaged and that no instruments or pieces are left in the patient. balseal disassociation potentially occurs secondary to damage to the tibial articulation surface during removal of the trial from the joint space or reprocessing. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 june 2015.

Device

ATTUNE INTUITION Tibial Articulation Surface Instruments
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: DePuy Synthes ATTUNE INTUITION Tibial Articulation Surface Instruments
  • Manufacturer
    DePuy Synthes

Manufacturer

DePuy Synthes