EasyDrill Cranial Perforator Ø14 x Ø11 x 1,5mm DM0210FAA (UDI 07898959543609)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07898959543609), received between Nov 4, 2024 and Dec 22, 2025 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device Remains Activated” (6 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT IN OPEN CRANIOTOMY PROCEDURE TO REMOVE BRAIN TUMOR THE BIT DID NOT STOP AUTOMATICALLY AND TORE THE PATIENT'S DURA MATER.THE PROCEDURE WAS EXTENDED FOR 5 MINUTES AND IT WAS COMPLETED BY THE BACKUP PRODUCTS.

  Patient problems: Perforation

  MAUDE report 23861727 ↗
• MalfunctionDec 19, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A BURR HOLE PROCEDURE, THREE PERFORATOR BROKE WHILE DRILLING. IT WAS REPORTED THAT PROCEDURE WAS DELAYED BY 20 MINUTES AND PROCEDURE WAS COMPLETED USING A MANUAL DRILL INSTEAD OF THE INTENDED POWERED DEVICE. AT THE TIME OF REPORT, THERE WAS NO KNOWN IMPACT TO A PATIENT. ADDITIONAL DETAILS REGARDING PATIENT IMPACT IS BEING FOLLOWED FROM THE FACILITY. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23847016 ↗
• MalfunctionDec 19, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A BURR HOLE PROCEDURE, THREE PERFORATOR BROKE WHILE DRILLING. IT WAS REPORTED THAT PROCEDURE WAS DELAYED BY 20 MINUTES AND PROCEDURE WAS COMPLETED USING A MANUAL DRILL INSTEAD OF THE INTENDED POWERED DEVICE. AT THE TIME OF REPORT, THERE WAS NO KNOWN IMPACT TO A PATIENT. ADDITIONAL DETAILS REGARDING PATIENT IMPACT IS BEING FOLLOWED FROM THE FACILITY. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23847014 ↗
• MalfunctionOct 22, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING A CRANIOTOMY PROCEDURE, THE PERFORATOR WAS USED WITH THE MIDAS REX MOTOR TO DRILL INTO THE CRANIAL BONE. THE SURGEON OBSERVED THAT THE BURR DID NOT STOP ROTATING AFTER COMPLETING THE BONE PERFORATION.  IT WAS ALSO REPORTED THAT NO INTERVENTION WAS PERFORMED AND THE PROCEDURE WAS COMPLETED USING THE SAME PRODUCT. IT WAS ALSO REPORTED THAT THERE WAS NO PROCEDURE DELAY AND NO PATIENT INJURY. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO PATIENT OR STAFF IMPACT AND THE RIGHT PARIETAL BONE OF THE SKULL WAS THE PERFORATED. IT WAS ALSO STATED THAT THE PATIENT HAVE RELEVANT NO BONE DISEASE OR COMORBIDITIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23356587 ↗
• MalfunctionMar 12, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING A STANDARD TUMOR RESECTION PROCEDURE, FAILURE OF EASY DRILL PERFORATOR. IT WAS REPORTED THAT THE PATIENT WAS ALIVE WITH NO INJURY. IT WAS ALSO REPORTED THAT THERE WAS NO INTERVENTION PLANNED. ON FOLLOW-UP IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT AND THERE WAS NO DELAY IN PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21583858 ↗
• MalfunctionMar 4, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE TO PERFORATE THE SKULL TO RESECT THE TUMOR THE PRODUCT GOT BROKEN AND THE UPPER PART FELL OFF FROM THE DEVICE. IT WAS ALSO REPORTED THAT THERE WAS NO INTERVENTION PERFORMED AND THERE WAS NO DELAY IN PROCEDURE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. ADDITIONAL INFORMATION REGARDING THE PATIENT IMPACT WAS BEING FOLLOWED UP FROM THE FACILITY. ON ADDITIONAL FOLLOW THE PATIENT SHOWED NO SIGNS OF BONE DISEASES. THE SURGERY WAS PERFORMED DUE TO A HEMATOMA IN THE PARIETAL BONE AREA. TWO HOLES WERE CREATED USING A PERFORATOR, BUT THE DEVICE ENCOUNTERED AN ISSUE WITH THE FIRST HOLE. THE EM200 MOTOR WAS USED DURING THE PROCEDURE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21515466 ↗
• MalfunctionDec 3, 2024Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING SHUNT INSERTION UNDER LAPAROSCOPY NAVIGATION, THE PERFORATOR DID NOT STOP WHILE DRILLING THROUGH THE SKULL BONE. IT WAS REPORTED THAT THE PATIENT WAS ALIVE - NO INJURY AND THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. UPON FOLLOWUP IT WAS CONFIRMED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20835852 ↗
• MalfunctionDec 1, 2024Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT IN THE PROCEDURE OF CRANIOTOMY THE DRILL DOESN'T MAKE CORRECT TURNS . IT STOPS FOR A WHILE THEN TURNS BACK ON. IT WAS REPORTED THAT INTERVENTION HAS BEEN PERFORMED. THE PROCEDURE WAS COMPLETED WITH THE BACKUP PRODUCT. UPON FOLLOWUP IT WAS CONFIRMED THAT THERE WAS NO PATIENT IMPACT. THERE WAS A DELAY FOR 30 MINUTES DURING THE PROCEDURE. NO INTERVENTION PERFORMED OR PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20814364 ↗
• InjuryNov 4, 2024Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT WHEN DRILLING BURR HOLE, THE PERFORATOR DID NOT STOP AUTOMATICALLY WHEN FINISHED DRILLING BONE CONTINUING TO DRILL AND TEAR DURA MATER. IT WAS ALSO REPORTED THAT THERE WAS A PROCEDURE DELAY OF 30 MINUTES AND DURAL REPAIR WAS REQUIRED. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT.

  Patient problems: Perforation

  MAUDE report 20597442 ↗