Events

Retiro De Equipo (Recall) de Synthes Connection Screw for Insertion of Dynamic Hip Screw (DHS) Blade

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Synthes GmbH.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    18463
  • Fecha de inicio del evento
    2015-11-09
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Johnson & Johnson (NZ) Limited, 13a Gabador Place, Mt Wellington, AUCKLAND
  • Causa
    Complaints of the insertion screw breaking inside the blade implant during insertion. when the dhs blade connecting screw breaks inside the implant, it blocks the locking mechanism that is important for rotational stability (ensuring the bone fragments maintain anatomical reduction). in the event that the tip of the connecting screw breaks intraoperatively, the implant locking mechanism (for rotational stability) cannot be secured., if the fragment cannot be retrieved, rotational stability is compromised and the blade needs to be replaced or additional lag screws implanted. this may lead to prolongation of surgical operating time, bone damage and subsequent interventions such as a total hip arthroplasty. if the fragment cannot be retrieved and remains in the dhs blade in the patient, this could lead to an adverse tissue reaction since the connecting screw is not made of implant grade stainless steel.
  • Acción
    Product to be returned to supplier

Device

Synthes Connection Screw for Insertion of Dynamic Hip Screw (DHS) Blade
  • Modelo / Serial
    Model: Part Number: 03.224.007, Affected: 32 lots
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH