FDA: Cranial perforator automatic clutch mechanism may fail to disengage

Editor's Note

The Food and Drug Administration (FDA), on September 28, issued a safety alert for cranial perforators with an automatic clutch mechanism.

Most cranial perforators are designed to automatically stop drilling after penetrating the skull to prevent the tip from unintentionally drilling into the brain. However this clutch mechanism may fail to disengage if manufacturer’s instructions for use are not followed.

From January 2005 through August 2015, the FDA received more than 300 reports of automatic clutch mechanisms failing to disengage, resulting in more than 200 injuries.

Failure to disengage is not specific to any brand of device. The risk of these devices failing can be mitigated through proper use, patient considerations, and device selection, the FDA says.

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.