[Posted 09/28/2015]
AUDIENCE: Neurology, Surgery, Risk Manager
ISSUE: Most cranial perforators are designed to automatically stop drilling after penetrating the skull to prevent the tip from unintentionally drilling or “plunging” into the brain. However, this clutch mechanism may fail to disengage if proper use, patient considerations, and device selection are not followed in accordance with the manufacturer’s instructions for use. The clinical consequences of cranial perforators failing to disengage can be serious. 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. These injury reports describe patient injuries including perforation of the brain’s protective covering just beneath the skull (dura mater), bleeding (hemorrhage), brain contusion, cerebral tissue damage, and decreased function of the brain (neurological deficit). The outcomes from these injuries have included seizures, damage to the portion of the brain responsible for language (aphasia), delayed/prolonged hospital stays, and the need for additional procedures.
The FDA analysis of currently available data suggests that failure to disengage is not specific to any manufacturer or brand of devices. The risk of these devices failing to disengage can be mitigated through proper use, patient considerations, and device selection in accordance with the device’s instructions for use. Failing to follow the manufacturer’s instructions for use can lead to the device not performing as expected, potentially placing patients at risk.
BACKGROUND: Cranial perforators are bone cutting and drilling medical devices used to create a small hole (burr hole) in a patient’s skull so that a neurosurgeon can access the brain during certain procedures. These devices often include a clutch mechanism that is designed to automatically disengage or stop the tip from drilling once it has penetrated the patient’s skull to prevent damage to the brain.
RECOMMENDATION: Review and follow the device labeling instructions for use for cranial perforators with an automatic clutch mechanism. See the FDA Safety Communication for more information, including specific recommendations for neurosurgeons.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[09/28/2015 - Safety Communication - FDA]
