Events

Rappel de ADJUSTABLE DRILL STOPS

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par MEDTRONIC OF CANADA 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
    30024
  • Classe de risque de l'événement
    I
  • Date de mise en oeuvre de l'événement
    2012-04-16
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    The purpose of this field action is to recall all lots of part number 876-460 6860460 and 6905712 surgical instruments used with various systems. upon investigation it was determined that there is a potential for the adjustable drill stop to inadvertently adjust depths when used under powered operation. no patient injuries have been reported to date. however using an 876-460 6860460 or 6905712 adjustable drill stop could cause irreversible neurologic injury if the adjustable drill stop inadvertently adjusted and the drill penetrated through the anterior or posterior cortex of the vertebral body. if this occurred it would necessitate immediate surgical intervention repairing any damage to the surrounding vasculature/neurologic structures.

Device

ADJUSTABLE DRILL STOPS
  • Modèle / numéro de série
    Model Catalog: 6905712 (Lot serial: All Lots); Model Catalog: 876-460 (Lot serial: All Lots); Model Catalog: 6860460 (Lot serial: All Lots)
  • Classification du dispositif
    Orthopedic Devices
  • Description du dispositif
    Adjustable Drill Stop
  • Manufacturer
    MEDTRONIC OF CANADA LTD.

Manufacturer

MEDTRONIC OF CANADA LTD.
  • Adresse du fabricant
    BRAMPTON
  • 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
    HC