EasyDrill Cranial Perforator Ø14 x Ø11 x 3mm DM0010FAA (UDI 07898959543593)Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 07898959543593), received between Apr 29, 2024 and Feb 23, 2026 — classified as 23 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Device Remains Activated” (41 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 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2026Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE DRILLING PROCESS, THE DRILL BROKE, AND THE WHITE PLASTIC PART BECAME DETACHED FROM THE METAL PART. NO PATIENT IMPACT REPORTED.

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

  MAUDE report 24424736 ↗
• MalfunctionFeb 2, 2026Device Remains Activated; Failure to Auto Stop; No Apparent Adverse Event

  IT WAS REPORTED THAT MALFUNCTION WITH A PERFORATOR ATTACHMENT, WHILE DOING LEFT SIDED BURR HOLES FOR THE EVACUATION OF A HEMATOMA. THE PERFORATOR WAS WORKING CORRECTLY FOR THE FIRST BURR HOLE BUT PLUNGED THROUGH THE SKULL ON THE SECOND BURR HOLE, THIS IS SUPPOSED TO HAVE A HARD STOP. EVERYTHING WAS CONNECTED CORRECTLY AND THE SETTINGS WERE NOT INCREASED ON THE ELECTRIC MIDAS. IT WAS REPORTED THAT THE PATIENT DID NOT SEEM TO BE INJURED BY THE PERFORATOR PLUNGING THROUGH THE SKULL. IT WAS REPORTED THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24231316 ↗
• MalfunctionDec 20, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING THE CRANIOTOMY PROCEDURE, THERE WAS NO DISENGAGEMENT OF THE PERFORATOR WHEN MAKING A DRILL HOLE WHICH RESULTED IN AN INJURY AND IATROGENIC DURAL OPENING WITH ENDANGERMENT OF THE INTEGRITY OF THE CORTICAL SURFACE (SURFACE OF THE BRAIN).ON ADDITIONAL FOLLOW UP THERE WAS NO PATIENT IMPACT REPORTED.

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

  MAUDE report 23858764 ↗
• MalfunctionDec 19, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A BURR HOLE PROCEDURE, THREE PERFORATORS 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 23847012 ↗
• MalfunctionDec 9, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE PERFORATOR , THE PERFORATOR TOOL WAS VERY SLOW AND DID NOT CUT THE BONE EFFECTIVELY. A SECOND PERFORATOR BIT FROM THE SAME LOT NUMBER WAS USED, WHICH WENT THROUGH THE BONE AND DID NOT STOP AS INTENDED. THE PRODUCT HAD CONTACT WITH THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCTS. NO INTERVENTIONS WERE PERFORMED OR PLANNED. THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 23756085 ↗
• MalfunctionDec 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING USE, THE PERFORATOR BROKE WHILE IN CONTACT WITH THE PATIENT. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCTS, AND NO INTERVENTION WAS PERFORMED OR PLANNED.

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

  MAUDE report 23713617 ↗
• MalfunctionNov 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SURGICAL TEAM USED A NEW PERFORATOR CUTTER, WHICH BECAME DAMAGED DURING USE. IT WAS REPORTED THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23666007 ↗
• MalfunctionNov 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SURGICAL TEAM USED A NEW PERFORATOR CUTTER WHICH BECAME DAMAGED DURING USE. IT WAS REPORTED THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23665357 ↗
• MalfunctionNov 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SURGICAL TEAM USED A NEW PERFORATOR CUTTER WHICH BECAME DAMAGED DURING USE. IT WAS REPORTED THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23654107 ↗
• MalfunctionNov 10, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING A CRANIOTOMY, THE BLADE'S STOP MECHANISM OF THE PERFORATOR FAILED IN THE PRESENCE OF DURA MATER. WE ARE UNSURE WHETHER THE REPORTED PRODUCT WAS USED NEW OR REUSED, AS THE INSTITUTION REUSES MIDAS REX MEDICAL DEVICES FOR COST REASONS. IT WAS ALSO REPORTED THAT THERE WAS NO INTERVENTION WAS PERFORMED AND NO DELAY IN PROCEDURE. THE PRODUCT HAD CONTACT WITH THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING THE REPORTED PRODUCT. AT THE TIME OF THE REPORT, THERE WAS NO KNOWN IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT AND NO MATERIAL RESIDUE REMAINED IN THE PATIENT, AND THERE IS NO COLLATERAL DAMAGE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23508308 ↗
• InjuryNov 10, 2025Device Remains Activated; Device Remains Activated

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE PERFORATOR BIT DIDN'T STOP IN SURGERY AS IT SHOULD BE. IT WAS ALSO REPORTED THAT THE PATIENT HAD A LITTLE HEMATOMA, BUT IN THE END EVERYTHING WENT FINE AND NO PROBLEMS AFTER. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT UNDERWENT A BRAIN BIOPSY THROUGH A BOREHOLE. A MEDTRONIC DISPOSABLE DRILL BIT WAS USED, WHICH SHOULD STOP AUTOMATICALLY AFTER GOING THROUGH THE SKULL AND LOSING RESISTANCE. HOWEVER, THIS DID NOT HAPPEN, AND THE DRILL CONTINUED TO ROTATE, ALSO DRILLING THE CORTEX AND CAUSING DAMAGE/LEAKAGE TO THE OUTERMOST LAYER OF THE PATIENT'S BRAIN. THE PATIENT WOKE UP FROM THE PROCEDURE WITHOUT ANY PROBLEMS AND UNDERWENT CT SCANS, WHICH SHOWED A SMALL HEMATOMA IN THE PATIENT. THE PRODUCT INFORMATION WAS WRITTEN DOWN, AND THE REPRESENTATIVE OF THE PRODUCT WILL BE INFORMED ABOUT THIS. ON FOLLOW UP IT WAS REPORTED THAT THE THERE WERE NO INTERVENTION PERFORMED, NO PRODUCT DAMAGE AND NO PROCEDURE DELAY, THE PROCEDURE COMPLETED NORMALLY.

  Patient problems: Hematoma; Perforation

  MAUDE report 23508236 ↗
• InjuryNov 4, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING THE TREPANATION PROCEDURE, THE PERFORATOR FAILED TO DISENGAGE, RESULTING IN INJURY TO THE DURA MATER AND A CEREBRAL CONTUSION, AND THE QUALITY OF CARE DEGRADED. IT WAS ALSO REPORTED THAT THEY ADJUSTED THEIR SURGICAL PLAN AND APPROACHED THE LESION FROM ANOTHER ANGLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation; Spinal Cord Injury

  MAUDE report 23462508 ↗
• InjuryOct 31, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT WITH A PERFORATOR PLUNGING WHILE DOING A BURR HOLE IN A DEEP BRAIN SIMULATION CASE LAST WEEK. IT WAS FINE FOR THE FIRST THEN PLUNGED AND TORE THE DURA ON THE SECOND ONE.

  Patient problems: Perforation

  MAUDE report 23437630 ↗
• MalfunctionOct 24, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE SAFETY STOP FAILED TO ENGAGE DURING USE OF TWO PERFORATOR BITS FROM DIFFERENT LOTS. A REPLACEMENT BIT WAS OPENED FOR THE SECOND BURR HOLE, WHICH REPORTEDLY EXPERIENCED THE SAME ISSUE. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23378865 ↗
• MalfunctionOct 24, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE SAFETY STOP FAILED TO ENGAGE DURING USE OF TWO PERFORATOR BITS FROM DIFFERENT LOTS. A REPLACEMENT BIT WAS OPENED FOR THE SECOND BURR HOLE, WHICH REPORTEDLY EXPERIENCED THE SAME ISSUE. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23378781 ↗
• InjuryOct 15, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE PERFORATOR DIDN'T STOP WHEN IT REACHED THE DURA AND MADE A DURA LACERATION. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT. ADDITIONAL INFORMATION REGARDING THE PATIENT IMPACT WAS BEING FOLLOWED UP FROM THE FACILITY.

  Patient problems: Laceration(s)

  MAUDE report 23297699 ↗
• MalfunctionSep 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A POSTERIOR FOSSA CRANIECTOMY PROCEDURE, THE PLASTIC PART OF THE TREPHINE BASE OF THE PERFORATOR REPORTEDLY BROKE AT ITS INSERTION POINT INTO THE MOTOR WHEN ANGULATION WAS PERFORMED. NO PATIENT IMPACT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23080988 ↗
• MalfunctionSep 8, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE SAFETY STOP FAILED TO ENGAGE DURING USE OF TWO PERFORATOR BITS FROM DIFFERENT LOTS. A REPLACEMENT BIT WAS OPENED FOR THE SECOND BURR HOLE, WHICH REPORTEDLY EXPERIENCED THE SAME ISSUE. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT IMPACT. ON FOLLOW-UP IT WAS CONFIRMED THAT THERE WAS A PROCEDURE DELAY OF LESS THAN 10 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22993170 ↗
• InjuryAug 28, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING A CRANIOTOMY FOR THE RESECTION OF A BRAIN TUMOR, WHILE PERFORMING THE SECOND BURR HOLE, THE DRILL DID NOT STOP AND CAUSED A CONTUSION IN THE PARENCHYMA. THE CRANIOTOMY WAS CARRIED OUT REGARDLESS, AND THE TUMOR EXCISION SURGERY WAS COMPLETED. IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY AND PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCTS. ON FOLLOWUP IT WAS REPORTED THAT THE REGION OF PERFORATION IS RIGHT PARASAGITTAL AND THERE WAS DURAL TEAR AND BONE FRAGMENT WENT TO THE CORTEX. THE PATIENT IS FINE AFTER THE EVENT.

  Patient problems: Perforation

  MAUDE report 22910765 ↗
• InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURA TEAR. NO PATIENT IMPACT REPORTED.

  Patient problems: Perforation

  MAUDE report 22882059 ↗
• MalfunctionAug 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TUMOR RESSECTION PROCEDURE, THE PERFORATOR BROKE AT HEAD TREPANATION. IT WAS REPORTED THAT THE FRACTURE DID NOT AFFECT THE PATIENT'S HEALTH AND THE BLADE DID NOT DAMAGE DURA. THE PROCEDURE WAS COMPLETED WITH BACKUP DEVICE AND THERE WAS A 10 MINUTE PROCEDURE DELAY DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22847885 ↗
• MalfunctionJul 29, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT WHEN USING THE ITEM, IT KEPT ON DRILLING ON 1 SIDE, AS THE OTHER SIDE WAS ALREADY THROUGH THE SKULL. LUCKILY NO DURA TEAR. IT WAS REPORTED THAT THE PATIENT WAS ALIVE - NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22641068 ↗
• InjuryJul 25, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING LEFT FRONTAL GLIOMA PROCEDURE, THE PRODUCT NORMALLY FUNCTION AS THE INTERNAL SHELL STOPS AFTER REACHING DURA OF BRAIN, BUT THE PRODUCT PUNCTURED DURA OF THE BRAIN AND DOCTOR MANAGED DOING DURAPLASTY. IT WAS ALSO REPORTED THAT PROCEDUREWAS DELAYED FOR AN HOUR AND PATIENT WAS EXPOSED TO ANAESTHESIA MORE TIME.

  Patient problems: Perforation

  MAUDE report 22606833 ↗
• MalfunctionJul 20, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT WHEN USING THE DISPOSABLE, THE FIRST AND 3RD HOLE PERFORMED WELL. THE SECOND HOLE DID NOT GO AS PLANNED: IT TOOK WAY TO LONG, WHEN THE DOCTOR STOPPED AND HAD A LOOK, IT ONLY WENT HALF THROUGH AND NOT COMPLETELY (AND THE DISPOSABLE DID NOT STOP). NO FURTHER INJURY OR SOMETHING LIKE THAT, BUT BECAUSE OF THE HISTORY WITH THIS DISPOSABLE THEY ARE VERY ANXIOUS TO HAVE A DURA TEAR OR A PLUNGE. AS MENTIONED, THE THIRD HOLE PERFORMED WELL. IT WAS REPORTED THAT THE PATIENT WAS ALIVE NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22552024 ↗
• MalfunctionJul 15, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE CONTINUES TO RUN. NO PATIENT IMPACT WAS REPORTED.

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

  MAUDE report 22511773 ↗