Events

Safety Alert for Drill Bit 2.0mm drilling depth 14mm, 3-flute, for Quick Coupling

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
    2014-11-18
  • Event Date Posted
    2014-11-18
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141118.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 2.0mm drilling depth 14mm, 3-flute, for quick coupling it has come to our attention that medical device manufacturer, synthes, has initiated a field safety corrective action concerning its drill bit 2.0mm drilling depth 14mm, 3-flute, for quick coupling (part no.: 03.617.914; lot no.: 8496070). it was discovered that a product of the above mentioned lot of 2.0 mm drill bits with 14mm stop/ zero-p had been manufactured with a tip that was 16mm. this 16mm component was then incorrectly packaged, labeled, and distributed as a 14mm drill bit. if the non-conforming drill bit passed unrecognized into the operation room and to the surgeon for use, the longer than intended drill bit could potentially penetrate the posterior wall of the vertebral body. this could potentially result in minor bone, soft tissue or disc damage or, in a worst-case scenario, damage to the spinal cord, meninges, or nerves with the potential for permanent injury. if a dural tear occurred intraoperatively, the necessary repair might lead to a significant lengthening of the surgery. the manufacturer advises users to quarantine and return the affected products. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 18 november 2014.

Device

Drill Bit 2.0mm drilling depth 14mm, 3-flute, for Quick Coupling
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Synthes Drill Bit 2.0mm drilling depth 14mm, 3-flute, for Quick Coupling
  • Manufacturer
    Synthes

Manufacturer

Synthes