Events

Alerte De Sécurité sur Commercial Name: Locked Intramedullary Rod System for Proximal Femur Osteosynthesis; registration 80145901636; risk class III; lot 2282830 (distributed to city of Rio de Janeiro-RJ)

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Johnson & Johnson do Brasil Indústria e Comercio de Produtos para Saúde Ltda; 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
  • ID de l'événement
    1902
  • Date
    2016-05-19
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notes supplémentaires dans les données
  • Cause
    Johnson & johnson of brazil industry and commerce of health products ltda. upon analyzing a complaint received, found that the pfn ø 10.0mm cannulated, left, 130 °, c 380mm received left rod engraving but was curved like a right rod. after further investigation, it was determined that two other batches (mentioned above) may be affected by this problem and were recorded as straight stems, but were curved as left stems. if a part is engraved with the wrong side, the nonconformity will probably not be discovered until the surgeon implants the rod. a surgeon will probably identify the incorrect impression and request a replacement stem. if the failure is identified at this time, a short surgical delay will occur as the situation is evaluated and the next steps are determined. if the surgeon discovers the deformity of the shaft before inserting it into the patient's femur, he / she may locate another nfp or change the size and complete the surgery. there may possibly be a surgical delay, depending on the availability of a sterile replacement / alternate.
  • Action
    Action code R2016005. Letter to customers //// Collection.

Device

Commercial Name: Locked Intramedullary Rod System for Proximal Femur Osteosynthesis; registration...

Manufacturer

Johnson & Johnson do Brasil Indústria e Comercio de Produtos para Saúde Ltda; Synthes GmbH