Events

Alerte De Sécurité sur Drill Bit 2.0mm drilling depth 14mm, 3-flute, for Quick Coupling

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
    2014-11-18
  • Date de publication de l'événement
    2014-11-18
  • 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_20141118.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 2.0mm drilling depth 14mm, 3-flute, for quick coupling it has come to our attention that medical device manufacturer, synthes, has initiated a field safety corrective action concerning its drill bit 2.0mm drilling depth 14mm, 3-flute, for quick coupling (part no.: 03.617.914; lot no.: 8496070). it was discovered that a product of the above mentioned lot of 2.0 mm drill bits with 14mm stop/ zero-p had been manufactured with a tip that was 16mm. this 16mm component was then incorrectly packaged, labeled, and distributed as a 14mm drill bit. if the non-conforming drill bit passed unrecognized into the operation room and to the surgeon for use, the longer than intended drill bit could potentially penetrate the posterior wall of the vertebral body. this could potentially result in minor bone, soft tissue or disc damage or, in a worst-case scenario, damage to the spinal cord, meninges, or nerves with the potential for permanent injury. if a dural tear occurred intraoperatively, the necessary repair might lead to a significant lengthening of the surgery. the manufacturer advises users to quarantine and return the affected products. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 18 november 2014.

Device

Drill Bit 2.0mm drilling depth 14mm, 3-flute, for Quick Coupling
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Synthes Drill Bit 2.0mm drilling depth 14mm, 3-flute, for Quick Coupling
  • Manufacturer
    Synthes

Manufacturer

Synthes