MIDAS REX MR8 MR8-AVS10 (UDI 00763000441371)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00763000441371), received between Aug 12, 2024 and Sep 29, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Detachment of Device or Device Component; Naturally Worn

  It was reported that the attachment with the report of bearings have fallen out, and the upper diameter of the attachment has become enlarged. It was reported that there was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929827 ↗
• MalfunctionSep 28, 2026No Apparent Adverse Event

  It was reported that the device was sent for preventive maintenance with no alleged issue. At the time of report, there was no patient impact. Additional information received upon evaluation stating that the bearing was misaligned.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917010 ↗
• MalfunctionSep 15, 2026Loss of Power

  It was reported that during testing, the device's variable dial was not working/ device seized. There was no patient involvement or impact during testing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50776714 ↗
• MalfunctionSep 11, 2026Naturally Worn

  It was reported that the upper part of the attachment is widened and split, probably due to excessive drill bit movement. There is no patient impact reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50726271 ↗
• MalfunctionJul 3, 2026Loss of Power

  IT WAS REPORTED THAT THE DEVICE SEIZED. NO PATIENT IMPACT WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25700860 ↗
• MalfunctionJul 2, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST, AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. AT THE TIME OF THE REPORT, THERE WAS NO KNOWN IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION

  Patient problems: Insufficient Information

  MAUDE report 25696343 ↗
• MalfunctionJul 2, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARING WAS FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25689529 ↗
• MalfunctionJul 2, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT PRIOR TO USE THE ATTACHMENT WAS NOT WORKING. AT THE TIME OF REPORT, THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25689156 ↗
• MalfunctionJul 1, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE ATTACHMENT HAD DISSATISFACTION. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION STATED THAT BEARING DETACHED FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25677874 ↗
• MalfunctionJun 30, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING USE,THE ATTACHMENT INNER RING CAME OUT, IT WAS REPORTED THAT THERE WAS PATIENT INVOLVEMENT. ADDITIONAL INFORMATION RECEIVED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25672487 ↗
• MalfunctionJun 27, 2026Overheating of Device

  IT WAS REPORTED THAT INTRA-OPERATIVELY, THE DEVICE WAS ALLEGED TO HAVE OVERHEATED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25645005 ↗
• MalfunctionJun 4, 2026Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WITH OVERHEATING AND BAD BEARING. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25389376 ↗
• MalfunctionMay 12, 2026Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST, AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. AT THE TIME OF THE REPORT, IMPACT TO THE PATIENT WAS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DURING CLEANING IT WAS NOTED THAT THE BEARINGS FELL OUT ,THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25148299 ↗
• MalfunctionMay 7, 2026Vibration

  IT WAS REPORTED THAT NON-STANDARD MOVEMENT IN THE DRILL PRIOR TO USE. IT WAS REPORTED THAT THERE WAS 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 25110052 ↗
• MalfunctionApr 8, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT THE ATTACHMENT WITH DRILL COULD NOT BE SEPARATED FROM THE MOTOR. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED THAT THE BEARINGS WERE DETACHED DURING THE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24814518 ↗
• MalfunctionApr 7, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE ATTACHMENT WITH THE REPORT OF NO REPORTED ISSUE. 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 24797597 ↗
• MalfunctionMar 18, 2026Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT WAS OVERHEATING. NO KNOWN PATIENT IMPACT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24629037 ↗
• MalfunctionAug 7, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION REGARDING THE PATIENT IMPACT IS BEING FOLLOWED UP FROM THE FACILITY.

  Patient problems: Insufficient Information

  MAUDE report 22735432 ↗
• MalfunctionAug 25, 2024Detachment of Device or Device Component; No Apparent Adverse Event; Detachment of Device or Device Component; No Apparent Adverse Event

  REPAIR REQUEST INITIATED FOR DEVICE WITH NO REPORTED MALFUNCTION. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT ON EVALUATION DUE TO DETACHED BEARINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20060824 ↗
• MalfunctionAug 12, 2024Detachment of Device or Device Component; No Apparent Adverse Event; Detachment of Device or Device Component; No Apparent Adverse Event

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF PROBLEM NOT REPORTED. NO PATIENT IMPACT REPORTED. REPAIR ESCALATED TO PRODUCT EVENT ON EVALUATION DUE TO DETACHED BEARING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19959073 ↗