Characterization of complications associated with cranial perforator drills in neurosurgery

Cranial perforator drills are standard neurosurgical devices used for burr hole craniotomy, designed to automatically disengage at the inner table to minimize injury risk. Despite safety features, malfunctions such as disengagement failure may lead to injury. We systematically analyzed device malfunctions, patient impacts, and temporal trends over 10 years in order to increase operator vigilance for common modes and consequences of perforator malfunction and provide a basis for device refinement.

The Manufacturer and User Facility Device Experience (MAUDE) database was queried for medical device reports (MDRs) from 2015 to 2024 for cranial perforator drills. Report descriptions were manually reviewed and categorized by event type, device problems, patient impacts, and operational impacts.

Out of 1857 reports, disengagement failure was most frequently reported (n = 1295/1857, 69.7 %), followed by component integrity issues (n = 447/1857, 24.1 %) power/stability failures (n = 225/1857, 12.1 %), device entrapment (n = 92/1857, 5.0 %), cutting inefficiency (n = 76/1857, 4.1 %), and thermal issues (n = 68/1857, 3.7 %). Nearly half of all MDRs (n = 866, 46.6 %) reported at least one patient impact. Among these, the most common were dural injury (n = 777/866, 89.7 %), leptomeningeal injury (n = 223/866, 25.8 %), parenchymal injury (n = 220/866, 25.4 %), and hemorrhage (n = 200/866, 23.1 %). Three reports described patient death, though only one was attributed to device malfunction.

Disengagement failure was the most commonly reported malfunction and frequently associated with meningeal and parenchymal injury. Other device problems were less frequent and often identified during testing rather than patient procedures. These findings highlight the need for heightened vigilance during use, structured training for device handling, and ongoing quality improvement to enhance patient safety.