Events

Avis De Sécurité sur Cortex Screw fl 4.5mm

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Synthes GmbH.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date
    2016-04-26
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    Two lots of 4.5mm cortex screws, length 20mm, may contain a 4.5mm cortex screw that is 22mm in length. the screws are both etched and labeled with the above 20mm part numbers. potential hazard: the outside package labeling and the etching on the product would indicate to the user that the screw is 2mm shorter than its actual length of 22mm. for non—sterile products, there is an opportunity to detect the issue if the screw is measured prior to placement into the tray/module. once the screw enters the operating room, either sterile or unsterile, the user should measure the screw prior to insertion. if detected at this time it may result in a surgical delay while a replacement is obtained or if the surgeon inserts the screw, determines it was the wrong length on radiographic imaging, and then removes and replaces it.

Device

Cortex Screw fl 4.5mm

Manufacturer

Synthes GmbH