Events

Rappel de Medtronic Navigated Solera Driver Tips for Spinal Surgery, Instrument set or kit models numbers (which contains the drivers)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Medtronic Australasia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2015-RN-00925-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-09-18
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00925-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    Complaints have been received by medtronic related to broken, bent or damaged screwdriver tips. under certain use conditions, the torque required to fully seat a pedicle screw may be higher than the screwdriver tip can withstand. those conditions include: • the hole for the screw not drilled to the proper diameter • the hole for the screw not tapped adequately, either in the diameter or the length • dense bone • large diameter screws the screwdriver tip breaking could result in the extension of the surgery due to the need to find a replacement screwdriver, and if broken, extract the broken tip from the screw to complete the insertion, or the removal of the tip from the patient.
  • Action
    Medtronic is modifying the instructions for use (IFU) for the navigated screwdrivers to add additional warnings related to the careful inspection of the instruments regularly for damage and the importance of knowledge of the operating procedures, patient selection, and product information. The revised IFUs will be included with all new navigated screwdrivers. Some images of conditions to look for during inspection is included in the customer letter. Revised IFUs will be also provided with the customer letter. This action has been closed-out on 19/08/2016.

Device

Medtronic Navigated Solera Driver Tips for Spinal Surgery, Instrument set or kit models numbers (...
  • Modèle / numéro de série
    Medtronic Navigated Solera Driver Tips for Spinal SurgeryModel numbers: 9735023, 9735024, 9735025, 9735026, 9735027, 9734856, 9734857, 9734279, 9734373 Instrument set or kit models numbers (which contains the drivers) - 9735283, 9735283-G02, 9734632, 9734647, 9734648, 9735281, 9735278, 9735282, 9735279, 9735280 All serial numbersARTG Numbers: 119952 and 120114
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA