Midas Rex MR8-23TD3030Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000335793), received between Jul 8, 2024 and Jun 24, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2025Fracture; Fracture

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF DISSECTING TOOL BREAKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22317573 ↗
• MalfunctionJun 16, 2025Fracture; Fracture

  IT WAS REPORTED THAT THERE WAS TOOL BROKE. NO PATIENT IMPACT REPORTED. IT WAS ALSO REPORTED THAT THERE WAS DELAY OF 10MINS, NO BROKEN PIECES OF THE REPORTED PRODUCT REMAIN INSIDE THE PATIENT'S BODY, PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). ON FOLLOWUP IT WAS CONFIRMED WITH THE PHYSICIAN THE DRILL FIRED OFF AT HIGH SPEED AND ALMOST HIT ANESTHESIA.

  Patient problems: Insufficient Information

  MAUDE report 22209892 ↗
• MalfunctionJul 8, 2024

  DURING CASE, A STERILE, SINGLE USE 23 CM 3.0 MEDTRONIC TWIST DRILL WAS OPENED. OR TEAM IMMEDIATELY NOTED THAT DRILL BIT WAS DISCOLORED AND APPEARED TO BE CONTAMINATED. ITEM WAS IMMEDIATELY GIVEN TO OR CASE MANAGER AND COMPANY VENDOR NOTIFIED. NO HARM TO PATIENT. DRILL BIT NEVER REACHED THE PATIENT OR THE STERILE FIELD. DRILL BIT REF #MR8-23TD3030, LOT #0223111521. DEVICE AVAILABLE IN CASE MANAGER'S OFFICE. COMPANY VENDOR WILL REPORT TO MEDTRONIC CASE MANAGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19689083 ↗