Events

Safety Alert for Drill Bit and Adjustable Drill Stop

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Synthes.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2012-09-03
  • Event Date Posted
    2012-09-03
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120903.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: synthes drill bit and adjustable drill stop it has come to our attention that medical device manufacturer, synthes, has issued a medical device safety alert concerning drill bit 2.5mm complete, 2-flute (part no. 03.613.010); 2.5 mm drill bit, graduated 12mm-26mm adjustable depth (part no. 03.613.011); and adjustable drill stop (part no. 03.613.012). according to the manufacturer, a recall of the vectra system graduated 2.5mm drill bit and the adjustable drill stop has been initiated. although the reported incidence is low, there is the potential for the drill stop to slip on the drill bit resulting in an adverse event. if the drill stop slips on the drill bit, it could result in the penetration of the posterior cortex, dural tear requiring repair, damage to the spinal cord, quadriplegia, and the risk of a potentially life-threatening event. the manufacturer advised users to stop using the affected products and not to utilize self-tapping screws (20-26mm) in the absence of this drill bit assembly. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 3 september 2012.

Device

Drill Bit and Adjustable Drill Stop
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Synthes Drill Bit and Adjustable Drill Stop
  • Manufacturer
    Synthes

Manufacturer

Synthes