Events

Recall of ADJUSTABLE DRILL STOPS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MEDTRONIC OF CANADA LTD..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    30024
  • Event Risk Class
    I
  • Event Initiated Date
    2012-04-16
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    Model Catalog: 6905712 (Lot serial: All Lots); Model Catalog: 876-460 (Lot serial: All Lots); Model Catalog: 6860460 (Lot serial: All Lots)
  • Product Classification
    Orthopedic Devices
  • Product Description
    Adjustable Drill Stop
  • Manufacturer
    MEDTRONIC OF CANADA LTD.

Manufacturer

MEDTRONIC OF CANADA LTD.
  • Manufacturer Address
    BRAMPTON
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “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