Midas Rex MR8 MR8-AA10 (UDI 00643169912335)Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00643169912335), received between May 5, 2021 and Sep 15, 2026 — classified as 50 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (24 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Difficult to Insert

  It was reported that the attachment is not holding onto the burr after being correctly locked. It was reported there was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50768781 ↗
• MalfunctionSep 10, 2026No Apparent Adverse Event

  It was reported that the customer had a dissatisfaction with the product. There was no patient impact in this event. Additional info rmation received on evaluation that the bearings were detached.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50712541 ↗
• MalfunctionAug 26, 2026Naturally Worn

  It was reported that during maintenance, the device doesn't work well and the suspicion is that there may be a problem with the bearings. At the time of event, there is no patient involvement. Additional information was received stating that detached bearings were found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50449373 ↗
• MalfunctionJul 2, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BEARING FELL OUT OF THE ATTACHMENT. THERE WAS NO IMPACT TO THE PATIENT IN THE EVENT AT THE TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25699707 ↗
• MalfunctionJul 1, 2026Loss of Power

  IT WAS REPORTED THAT THE ATTACHMENT WAS NOT WORKING PROPERLY. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25677556 ↗
• MalfunctionJun 24, 2026No Apparent Adverse Event

  IT IS REPORTED THAT THE  DEVICE WITH THE REPORT OF GENERAL DISSATISFACTION .AT THE TIME OF THE REPORT, THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25612768 ↗
• MalfunctionJun 19, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT ATTACHMENT WAS NOT WORKING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25559545 ↗
• MalfunctionJun 18, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT SCHEDULED PREVENTIVE MAINTENANCE SERVICE WAS REQUESTED FOR ATTACHMENT. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION RECEIVED STATING BEARING WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25542204 ↗
• MalfunctionJun 11, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT BEARING WAS DETACHED IN THE ATTACHMENT. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25470441 ↗
• MalfunctionJun 9, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ATTACHMENT WITH THE REPORT OF BEARING DETACHMENT. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25439136 ↗
• MalfunctionJun 9, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ATTACHMENT BEARING FELL OUT. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25439077 ↗
• MalfunctionJun 5, 2026Difficult to Insert

  IT WAS REPORTED THAT THE ATTACHMENT DID NOT LOCK WHEN PICKING UP DRILLS. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25404672 ↗
• MalfunctionJun 4, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE MOTOR WAS DEFECTIVE. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED STATED THAT THE DISTAL BEARING IS DETACHED DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25386752 ↗
• MalfunctionMay 25, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO USE; THE ATTACHMENT PARTS FELL OFF. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25270646 ↗
• MalfunctionMay 20, 2026Loss of Power

  IT WAS REPORTED THAT THE ATTACHMENT DOES NOT WORK WELL. AT THE TIME OF EVENT, THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25228283 ↗
• MalfunctionMay 19, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE ATTACHMENT DOES NOT WORK WELL. AT THE TIME OF THE REPORT, THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25220161 ↗
• MalfunctionApr 3, 2026Difficult to Remove

  IT WAS REPORTED THAT THE DRILL BIT WAS STUCK IN ATTACHMENT. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24776009 ↗
• MalfunctionSep 16, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23060428 ↗
• MalfunctionJun 11, 2025Smoking; Detachment of Device or Device Component; Smoking; Detachment of Device or Device Component

  IT WAS REPORTED THAT ONE OF THE DRILLS DID SMOKE DURING THE SURGERY AND THE OTHER DRILL THERE IS A BROKEN BLACK PIECE THAT FELT OF DURING THE SURGERY. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). ON FOLLOW-UP IT WAS REPORTED THAT THERE WERE NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22182642 ↗
• MalfunctionJun 10, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT TOOL LOCKING MECHANISM SEIZED. THERE WAS NO PATIENT INVOLVED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22179084 ↗
• MalfunctionApr 2, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO PRODUCT EVENT DUE TO CUSTOMER INDICATION THAT THIS REPORT IS A COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21754648 ↗
• MalfunctionMar 4, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. 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 21511821 ↗
• MalfunctionFeb 23, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT DUE TO REASON FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21442472 ↗
• MalfunctionFeb 23, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT WAS REPORTED. ON FOLLOW-UP IT WAS REPORTED THAT THERE WERE NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21442371 ↗
• MalfunctionFeb 20, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR THE DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21420359 ↗