MIDAS REX MR8 MR8-AA10 (UDI 00763000440848)Recalls & reported problems

Summary

The FDA's MAUDE database contains 192 adverse event reports that list this exact device (DI 00763000440848), received between Dec 12, 2023 and Sep 29, 2026 — classified as 1 injury, 191 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (44 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 25 most recent of 192 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Naturally Worn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933818 ↗
• MalfunctionSep 28, 2026No Apparent Adverse Event

  It was reported that there was no alleged issue at the time of intake. It was reported that there was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911861 ↗
• MalfunctionSep 28, 2026Loss of Power

  It was reported that the device was frozen. There was no patient involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910941 ↗
• MalfunctionSep 25, 2026Naturally Worn

  It was reported that during testing the device was observed with bearing issue. There was no patient involvement. Additional information received on evaluation stated that bearing was misaligned made this event reportable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50894948 ↗
• MalfunctionSep 23, 2026No Apparent Adverse Event

  Medtronic received information regarding a repair request, and no alleged product deficiencies were reported. At the time of report there was no patient impact. Additional information was received stating that detached distal bearings were found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50866229 ↗
• MalfunctionSep 23, 2026No Apparent Adverse Event

  It was reported that the device was broken. At the time of report, there was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50865398 ↗
• MalfunctionSep 23, 2026No Apparent Adverse Event

  It was reported that device was broken. At the time of report there was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50865217 ↗
• MalfunctionSep 23, 2026Difficult to Remove

  It was reported that the angled attachment has stuck in the shaft. There was no patient involved. Additional information stated that the detached bearing was found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50864507 ↗
• MalfunctionSep 11, 2026Loss of Power

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50742489 ↗
• MalfunctionSep 9, 2026No Apparent Adverse Event

  Medtronic received information regarding a repair request, and no alleged product deficiencies were reported. There was no patient i nvolvement. Additional information was received stating that the bearings were detached.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50685383 ↗
• MalfunctionAug 26, 2026Material Deformation

  It was reported that markings were damaged/missing/illegible. No patient impact was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50449989 ↗
• MalfunctionAug 25, 2026Detachment of Device or Device Component

  It was reported that the angled attachment has bearing fell out. There was no patient involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50423900 ↗
• MalfunctionAug 20, 2026Overheating of Device

  It was reported that pre-op, overheating. At the time of report there was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50346513 ↗
• MalfunctionAug 18, 2026Detachment of Device or Device Component

  It was reported that Ball bearing fell out / missing. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50295414 ↗
• MalfunctionAug 17, 2026Overheating of Device

  It was reported that during intraop the attachment was overheating. 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 50274421 ↗
• MalfunctionAug 17, 2026Difficult to Insert

  It was reported that the attachment was frozen. It was reported that there was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50271689 ↗
• MalfunctionAug 17, 2026Difficult to Insert

  It was reported that the attachment does not retain tool. It was reported there was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50271659 ↗
• MalfunctionAug 17, 2026Difficult to Insert

  It was reported that the cutter tool could not be locked to attachment. It was reported that there was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50270083 ↗
• MalfunctionAug 17, 2026No Apparent Adverse Event

  It was reported that customer had a dissatisfaction with the attachment. It was reported that there was no patient or staff impact. Additional information was received stating that bearings were detached found in analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50269119 ↗
• MalfunctionJul 28, 2026No Apparent Adverse Event

  It was reported that the attachment was not working. 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 50049798 ↗
• MalfunctionJul 6, 2026Difficult to Insert

  IT WAS REPORTED THAT THE ATTACHMENT WAS NOT ABLE TO RETAIN TOOL. THERE IS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25714721 ↗
• MalfunctionJul 6, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE ATTACHMENT WAS DEFECTIVE. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25713762 ↗
• MalfunctionJul 5, 2026Vibration

  IT WAS REPORTED THAT THE DEVICE WITH TOOL WAS VIBRATING, NOT STABLE. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25712909 ↗
• 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 INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25692646 ↗
• MalfunctionJul 2, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25689392 ↗