EasyDrill Cranial Perforator Ø11 x Ø7 x 3mm DM0011FAA (UDI 07898959543616)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07898959543616), received between Apr 29, 2025 and Dec 3, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A VENTRICULOPERITONEAL SHUNT PROCEDURE, WHILE USING THE MIDAS DISPOSABLE CRANIAL PERFORATOR, THE SURGEON ALLEGED THAT THE PERFORATOR CAUSED DAMAGE TO THE BRAIN. THE EVENT OCCURRED DURING DRILLING. IT WAS ALSO NOTED THAT THE PERFORATOR WAS USED WITH THE MOTOR AND ATTACHMENT COMBINATION (MOTOR AND ATTACHMENT). THERE WAS AN ASSOCIATED PROCEDURE DELAY OF APPROXIMATELY ONE TO TWO HOURS. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION AFTER THE OPERATION, AND NO FRAGMENTS REMAINED INSIDE THE PATIENT. THE USER INDICATED THAT THE PERFORATOR PENETRATED THE BONE BUT DID NOT STOP. THE MALFUNCTION OCCURRED ON THE FIRST HOLE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CUSTOMER CONFIRMED NO ADDITIONAL MALFUNCTIONS WERE IDENTIFIED WITH THE PERFORATOR, MOTOR, OR ATTACHMENT. IT WAS REPORTED THERE WAS NO PATIENT IMPACT, AND THE PATIENT IS RECOVERING WITHOUT COMPLICATIONS.

  Patient problems: Perforation

  MAUDE report 23702208 ↗
• MalfunctionApr 29, 2025Fracture; Fracture

  UPON FOLLOWUP IT WAS CONFIRMED THAT THE PROCEDURE WAS COMPLETED WITH THE BACKUP PRODUCT. NO ADDITIONAL INTERVENTION WAS PERFORMED OR PLANNED AS A RESULT OF THIS EVENT.THERE WAS A DELAY OF 10 MINUTES IN THE PROCEDURE. IT WAS CONFIRMED THAT THERE WAS NO PATIENT IMPACT.

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

  MAUDE report 21927206 ↗