Events

Alerte De Sécurité sur Hexagonal Socket, Ø 4.0mm/11.0mm

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 GmbH.

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
    2015-08-07
  • Date de publication de l'événement
    2015-08-07
  • 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_20150807_b.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 gmbh hexagonal socket, ø 4.0mm/11.0mm medical device manufacturer, synthes gmbh, has issued a medical device safety alert concerning its hexagonal socket, ø 4.0mm/11.0mm [part number: 356.714; lot number: all]. the manufacturer is initiating a voluntary medical device recall of the above mentioned part and lot numbers of the depuy synthes hexagonal socket, ø 4.0mm/11.0mm. the socket is a cannulated instrument used to insert the end caps in the following nail systems: proximal femoral nail anti-rotation (pfna), pfna-ii, and the antegrade femoral nail (afn). there is a potential for the socket-hex tip to break into fragments during use if too much force is applied. breakage of the hex tip may result in surgical delay and an adverse tissue reaction. as the affected item has been reported to break intra-operatively, there is potential for surgical delay while the fragments are retrieved. consequently, surgical delay may occur while a replacement instrument or alternative device is located to insert the end cap. in addition, an adverse tissue reaction may possibly occur if any stainless steel fragments from the socket are not retrieved from the patient. 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 07 august 2015.

Device

Hexagonal Socket, Ø 4.0mm/11.0mm
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Synthes GmbH Hexagonal Socket, Ø 4.0mm/11.0mm
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH