Events

Avis De Sécurité sur Offset Reamer Handle

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 Greatbatch Medical.

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
  • 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
    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