EasyDrill Cranial Perforator Ø14 x Ø11 x 3mm DM0010FAA (UDI 07898959543197)Recalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 07898959543197), received between Jul 28, 2020 and Apr 17, 2025 — classified as 50 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Device Remains Activated” (66 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 25 most recent of 67 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2025Fracture; No Apparent Adverse Event; Fracture; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING R FTP CRANIOTOMY, PERFORATOR BIT WAS BROKEN, AFTER MADE A BURR HOLE. NO PATIENT IMPACT REPORTED. ON FOLLOW-UP IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21856590 ↗
• InjuryAug 19, 2022Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING CRANIOTOMY PROCEDURE, TREPAN DID NOT STOP IN FRONT OF DURA AND, THE STATUS OF PATIENT WAS GETTING WORSENED. A COMPUTED TOMOGRAPHY INTERVENTION WAS PERFORMED WHICH CONFIRMED THAT THERE IS A BLEEDING INSIDE OF PATIENT'S HEAD AND RE-PROCEDURE WAS CARRIED OUT. IT WAS ALSO REPORTED THAT PATIENT HAS TO BE IN HOSPITAL JUST FOR 2-3 DAYS BUT BECAUSE OF PRODUCT FAILURE PATIENT HAS TO STAY OVER 20 DAYS. IT WAS ALSO REPORTED THAT THERE IS A PROCEDURE DELAY OF 10 MINUTES IN FIRST PROCEDURE AND APPROXIMATELY 120 MINUTES IN THE SECOND PROCEDURE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation; Unintended Radiation Exposure

  MAUDE report 15259255 ↗
• InjuryAug 17, 2022Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING THE SURGERY, THE PERFORATOR DID NOT STOP WHEN IT GOT THROUGH THE BONE IN THE SKULL, IT PLUNGED AND CONTINUED TO SPIN. IT WAS REPORTED THAT THERE WAS AN INTERVENTION THAT USE CAUTERY AND SURGICELL TO STOP MINOR BLEEDING AS DURA WAS PULLED OFF AND PROCEDURE GOT 15 MINUTES DELAY. IT WAS ALSO STATED THE PROCEDURE WAS COMPLETED WITH BACK UP DEVICE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 15238708 ↗
• MalfunctionAug 17, 2022Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING THE SURGERY, THE PERFORATOR COULDN¿T STOP SPINNING. NO PATIENT IMPACT WAS REPORTED. ADDITIONAL INFORMATION REGARDING THE PATIENT IMPACT WAS BEING FOLLOWED UP FROM THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15238636 ↗
• MalfunctionAug 11, 2022Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE PERFORATOR THAT KEPT SPINNING AND GOING THROUGH THE BOUND. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION REGARDING THE PRODUCT RETURN WAS BEING FOLLOWED UP.

  Patient problems: Perforation

  MAUDE report 15207486 ↗
• MalfunctionJun 30, 2022Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING STEREOTACTIC BRAIN BIOPSY, WHILE MAKING THE CRANIAL BURR HOLE, THE PERFORATOR CLUTCH DID NOT ENGAGE AND THE BIT CUT BEYOND THE INTENDED STOP POINT ON THE SKULL. ADDITIONAL INFORMATION REGARDING THE EVENT WAS BEING FOLLOWED UP FROM THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Perforation

  MAUDE report 14871855 ↗
• InjuryJun 10, 2022Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE PERFORATOR DID NOT STOP WHEN IT REACHED THE DURA AND THE PERFORATOR TORE THE DURA APART. ON FOLLOW-UP IT WAS REPORTED THAT THERE IS NO DELAY IN SURGICAL PROCEDURE, DURA SUTURED IN THE SAME SURGERY AND PATIENT ALIVE WITH NO INJURY AFTER THE SURGERY.

  Patient problems: Perforation

  MAUDE report 14652755 ↗
• InjuryMay 16, 2022Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING CRANIOTOMY PROCEDURE, WHILE DRILLING, THE PERFORATOR DIDN'T STOPPED AUTOMATICALLY AFTER HITTING THE PATIENT'S DURA. IT WAS ALSO REPORTED THAT THERE WAS NO PROCEDURE DELAY AND THE PROCEDURE WAS COMPLETED WITH REPORTED DEVICE. ADDITIONAL INFORMATION REGARDING THE PATIENT IMPACT WAS BEING FOLLOWED UP FROM THE FACILITY.

  Patient problems: Perforation

  MAUDE report 14408347 ↗
• InjuryDec 23, 2021Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT WHILE MAKING A BURR HOLE FOR A CRANIOTOMY PROCEDURE, THE PATIENT DURA WAS PERFORATED. ON FOLLOW UP IT WAS REPORTED THAT THERE WAS A PROCEDURE DELAY FOR 30 MINUTES DUE TO THE APPLICATION OF DURAGEN AND DURASEAL TO THE HOLE CREATED BY MALFUNCTION. IT WAS ALSO REPORTED THAT NO BACK UP DEVICE WAS USED TO COMPLETE THE PROCEDURE. ON FOLLOW UP, IT WAS REPORTED THAT PATIENT IS CURRENTLY IN ICU AT (B)(6) HOSPITAL IN (B)(6) AND DATE OF SURGERY WAS (B)(6) 2021.

  Patient problems: Perforation

  MAUDE report 13072314 ↗
• MalfunctionOct 22, 2021Device Remains Activated; Dull, Blunt; Device Remains Activated; Dull, Blunt

  ON FOLLOW-UP, IT WAS REPORTED THAT THE DEVICE ROTATED BUT IT DOES NOT PERFORATE. IT WAS REPORTED THAT THERE WAS A 30-MINUTE PROCEDURE DELAY TO PREPARE A BACKUP DEVICE AND COMPLETE THE PROCEDURE. IT WAS ALSO CONFIRMED THAT THE PATIENT HAD NO FURTHER ISSUES POST-SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12685380 ↗
• InjuryOct 20, 2021Device Remains Activated; Dull, Blunt; Device Remains Activated; Dull, Blunt

  ON FOLLOW-UP, IT WAS REPORTED THAT THE CT SCAN PROCEDURE PERFORMED WAS PART OF THE ROUTINE PROCEDURE. IT WAS ALSO REPORTED THAT THEY CAN WAIT 1-2 DAYS BEFORE DOING THE CT SCAN PROCEDURE, HOWEVER, IT WAS REQUESTED TO BE PERFORMED IMMEDIATELY AFTER THE SURGERY TO CHECK IF THERE WAS AN INJURY DUE TO THE EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation; Unintended Radiation Exposure

  MAUDE report 12669264 ↗
• InjuryOct 19, 2021Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING A CRANIAL CASE, THERE WAS A PLUNGE INCIDENT WHILE USING THE DEVICE. NO PATIENT IMPACT REPORTED. ON FOLLOW-UP, IT WAS REPORTED THAT THERE WAS A 2-5 MIN PROCEDURE DELAY TO CONTROL THE BLEEDING AND THE PROCEDURE WAS COMPLETED USING THE REPORTED DEVICE. IT WAS ALSO CONFIRMED THAT THE PATIENT HAD NO FURTHER ISSUES POST-SURGERY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 12661800 ↗
• InjuryOct 19, 2021Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING A CRANIAL PROCEDURE, THE PERFORATOR DID NOT STOP AND DAMAGED THE CRANIAL AREA. IT WAS REPORTED THAT THERE'S A BLEEDING IN THE WERNICKE'S AREA AND AN INTERVENTION HAS BEEN PERFORMED. IT WAS ALSO REPORTED THAT THERE WAS NO PROCEDURE DELAY, THE PROCEDURE WAS COMPLETED USING THE REPORTED PRODUCT, AND THE DEVICE HAS BEEN LOST.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 12661598 ↗
• MalfunctionSep 8, 2021Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THERE WAS AN ALLEGED PATIENT/USER IMPACT. ON FOLLOW-UP, IT WAS REPORTED THAT THE EVENT HAPPENED DURING A LEAD IMPLANT AND DBS PROCEDURE, THERE WAS NO PROCEDURE DELAY, AND THE PROCEDURE WAS COMPLETED USING A BACKUP DEVICE. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT AND THE PATIENT HAD NO FURTHER ISSUES POST-SURGERY. ON FURTHER FOLLOW-UP, IT WAS REPORTED THAT THE MIDAS REX DRILL DID NOT STOP DURING PENETRATION TO THE SKULL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12443387 ↗
• InjuryAug 31, 2021Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE PERFORATOR DID NOT STOP, PERFORATING DURA IN 2 OF THE 4 BURR HOLES. IT WAS ALSO REPORTED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT HAS BEEN DISCARDED BY THE CUSTOMER. ON FOLLOW-UP, IT WAS REPORTED THAT THE EVENT HAPPENED DURING A CRANIOTOMY PROCEDURE FOR TUMOR THAT APPEARS TO BE A MENINGIOMA. IT WAS REPORTED THAT THE AFFECTED DURA WAS REMOVED AS PER PROCEDURE, THERE WAS NO PROCEDURE DELAY OR NON-ROUTINE ACTIONS TAKEN BECAUSE OF THE EVENT, AND THE PATIENT HAD NO FURTHER ISSUES POST-SURGERY.

  Patient problems: Perforation

  MAUDE report 12397612 ↗
• InjuryAug 27, 2021Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE PERFORATOR DID NOT STOP ROTATING AND CAUSED DURA DAMAGE. ON FOLLOW-UP, IT WAS REPORTED THAT THE EVENT HAPPENED DURING A LUMBAR DECOMPRESSION PROCEDURE, THERE WAS NO PROCEDURE DELAY, AND THE PROCEDURE WAS COMPLETED USING A COMPETITIVE PERFORATOR. IT WAS ALSO REPORTED THAT THE PATIENT HAD NO FURTHER ISSUES POST-SURGERY.

  Patient problems: Perforation

  MAUDE report 12380808 ↗
• InjuryAug 3, 2021Device Remains Activated; Device Remains Activated

  ON FURTHER FOLLOW UP IT WAS REPORTED THAT PROCEDURE IS CRANIOTOMY AND THERE WAS A DELAY IN PROCEDURE FOR 15 MINUTES. IT WAS ALSO REPORTED THAT THEY NEED TO REPAIR DURA AND SOME DAMAGE IN TISSUE DURING THE DELAY.

  Patient problems: Perforation; Unspecified Tissue Injury

  MAUDE report 12271012 ↗
• InjuryJul 6, 2021Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PATIENT SUSTAINED A MILD INJURY WHILE USING THE DEVICE. IT WAS ALSO REPORTED THAT THERE WAS NO PROCEDURE DELAY AND THE PROCEDURE WAS COMPLETED USING THE REPORTED PRODUCT. ON FOLLOW-UP, IT WAS CONFIRMED THAT THE DEVICE DID NOT STOP DURING THE PROCEDURE FOR A PARKINSON CASE WHICH CAUSED A SMALL DURA TEAR. IT WAS ALSO REPORTED THAT THE PATIENT HAD NO FURTHER ISSUES POST-SURGERY AND THE DEVICE WAS DISCARDED.

  Patient problems: Perforation

  MAUDE report 12125546 ↗
• InjuryJun 28, 2021Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE CLUTCH OF THE PERFORATOR DID NOT ENGAGE WHEN HITTING THE DURA. ON FOLLOW-UP, IT WAS REPORTED THAT THE EVENT HAPPENED DURING A FRONTAL CRANIOTOMY PROCEDURE, THERE WAS NO PROCEDURE DELAY, AND THE PROCEDURE WAS COMPLETED USING THE REPORTED DEVICE. IT WAS ALSO REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE STATUS OF THE PATIENT POST-SURGERY.

  Patient problems: Perforation

  MAUDE report 12077395 ↗
• MalfunctionJun 28, 2021Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE PERFORATOR DID NOT STOP. NO PATIENT IMPACT REPORTED. ON FOLLOW-UP, NO FURTHER INFORMATION CAN BE PROVIDED REGARDING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12075054 ↗
• InjuryMay 28, 2021Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION PROCEDURE, THE PERFORATOR PLUNGED AND CAUSED A SMALL DURA TEAR. ON FOLLOW-UP, IT WAS REPORTED THAT THERE WAS NO ADDITIONAL INTERVENTION PERFORMED BECAUSE OF THE EVENT, THERE WAS NO PROCEDURE DELAY, AND THE PROCEDURE WAS COMPLETED USING THE REPORTED DEVICE. IT WAS ALSO REPORTED THAT THE PATIENT HAD NO FURTHER ISSUES POST-OPERATION.

  Patient problems: Perforation

  MAUDE report 11904449 ↗
• InjuryMay 26, 2021Device Remains Activated; Device Remains Activated

  ON FOLLOW-UP, IT WAS REPORTED THAT THE PATIENT HAD NO FURTHER ISSUES POST-SURGERY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 11890379 ↗
• InjuryMay 26, 2021Device Remains Activated; Device Remains Activated

  ON FOLLOW-UP, IT WAS REPORTED THAT THE PATIENT HAD NO FURTHER ISSUES POST-SURGERY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 11890264 ↗
• InjuryMay 21, 2021Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT WHILE MAKING A BURR HOLE FOR A CRANIAL PROCEDURE, THE EASYDRILL DID NOT STOP AND DAMAGED THE DURA. IT WAS ALSO REPORTED THAT THERE WERE NO ADDITIONAL INTERVENTIONS TAKEN BECAUSE OF THE EVENT, THERE WAS NO PROCEDURE DELAY, AND THE PROCEDURE WAS COMPLETED USING THE REPORTED DEVICE. ON FOLLOW-UP, IT WAS CONFIRMED THAT THE PATIENT HAD NO FURTHER ISSUES POST-SURGERY.

  Patient problems: Perforation

  MAUDE report 11863946 ↗
• InjuryMay 21, 2021Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT WHILE MAKING A BURR HOLE FOR A CRANIAL SURGICAL PROCEDURE, THE PERFORATOR DIDN'T STOP AND THE DURA WAS DAMAGED. IT WAS ALSO REPORTED THAT THERE WERE NO ADDITIONAL INTERVENTIONS PERFORMED, THERE WAS NO PROCEDURE DELAY, AND THE PROCEDURE WAS COMPLETED USING THE REPORTED DEVICE. ON FOLLOW-UP, IT WAS CONFIRMED THAT THE PATIENT HAD NO FURTHER ISSUES POST-SURGERY.

  Patient problems: Perforation

  MAUDE report 11863846 ↗