Events

Notificaciones De Seguridad De Campo acerca de Offset Reamer Handle

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Greatbatch Medical.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    On june 14, 2016 greatbatch medical identified an issue with the 00-7804-080-00 offset reamer handle, as field complaints were reported that the drive chain mechanism seizes during use. the function of the drive chain mechanism is to transmit rotational power from a mechanical drill to an acetabular reamer during a total hip arthroplasty. during seizing, the device is rendered non- functional in the operating room. the risks associated with this failure are: 1. the offset reamer handle seizes and the surgery must be completed with an alternate device, leading to a delay of 30 minutes or greater from the scheduled surgery time. 2. the offset reamer handle seizes and no replacement device is available in the hospital, leading to an interruption and rescheduling of surgery. .

Device

Offset Reamer Handle

Manufacturer

Greatbatch Medical