Regulatory Focus™ > News Articles > Neurourgeons Beware: Cranial Perforators May Fail to Automatically Disengage, FDA Says

Neurourgeons Beware: Cranial Perforators May Fail to Automatically Disengage, FDA Says

Posted 28 September 2015 | By Zachary Brennan 

Neurourgeons Beware: Cranial Perforators May Fail to Automatically Disengage, FDA Says

Although some cranial perforators are designed to automatically stop after penetrating the skull (to prevent from unintentionally drilling into the brain), the automatic clutch mechanism may fail to disengage on a range of devices, the US Food and Drug Administration (FDA) warned on Monday.

FDA said its analysis of currently available data suggests that this "failure to disengage" is not specific to any manufacturer or brand of devices, though it can be mitigated through proper use, patient considerations, and device selection in accordance with instructions for use. Failing to follow the manufacturer’s instructions can lead to the device not performing as expected, potentially placing patients at risk, FDA says.

From January 2005 through August 2015, FDA received over 300 medical device reports (MDRs) associated with the use of cranial perforators with an automatic clutch mechanism failing to disengage, resulting in over 200 injuries.

The injury reports describe perforation of the brain’s protective covering just beneath the skull, bleeding, brain contusion, cerebral tissue damage and decreased function of the brain. Outcomes from the injuries have included seizures, damage to the portion of the brain responsible for language, delayed/prolonged hospital stays and the need for additional procedures.

FDA is calling on neurosurgeons to:

  • review and follow the device labeling instructions for use for cranial perforators with an automatic clutch mechanism
  • utilize correct techniques for cranial perforators with an automatic clutch mechanism
  • be cautious when using a cranial perforator with an automatic clutch mechanism if the surgeon
    • Perforates areas of the skull that have variations in bone contours and thickness such as the posterior fossa.
    • Perforate the skull of infants, children, or elderly patients because of varying skull consistency and thickness of bone.
    • Perforate a patient’s skull if there is diseased or fragile bone or the possibility of adherent underlying dura mater.

Neurosurgeons were also told to report any adverse events associated with the use of cranial perforators with an automatic clutch mechanism to the FDA and the manufacturer.

FDA Warning


Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe