MIDAS REX MR8 MR8-AF02R (UDI 00763000441012)Recalls & reported problems

Summary

The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 00763000441012), received between Mar 13, 2024 and Sep 30, 2026 — classified as 86 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (17 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 86 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954712 ↗
• MalfunctionSep 30, 2026Loss of Power

  It was reported that during use the device was not working. There was no patient involvement. Additional information received upon evaluation stating that the bearings got detached.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951895 ↗
• MalfunctionSep 30, 2026Difficult to Insert

  It was reported that the attachment no longer holds the saw properly. At the time of the report, there was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943695 ↗
• MalfunctionSep 29, 2026No Apparent Adverse Event

  Medtronic received information regarding a planned maintenance with no alleged product deficiency. There was no patient involvement. Additional information was received stating bearing detachment was found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929902 ↗
• MalfunctionSep 29, 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 bearings were detached.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929262 ↗
• MalfunctionSep 29, 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 or staff impact. Additional information was received stating detached bearings were found in evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927722 ↗
• MalfunctionSep 28, 2026Difficult to Insert

  It was reported that pre-op, difficult to insert tool. At the time of report there was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911542 ↗
• MalfunctionSep 25, 2026Difficult to Remove; Detachment of Device or Device Component

  It was reported that a part was stuck inside. It was reported that there was no patient or staff impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895582 ↗
• MalfunctionSep 25, 2026No Apparent Adverse Event

  It was reported that the device was defective . At the time of report there was no patient impact. Additional information received that the bearings were found to be detached during evaluation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50894420 ↗
• MalfunctionSep 24, 2026No Apparent Adverse Event

  Medtronic received information regarding a repair request, and no alleged product deficiencies were reported. There is no patient impact reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882695 ↗
• MalfunctionSep 24, 2026Naturally Worn

  It was reported that the device had detached bearings. At the time of the report, patient impact details are unknown. Additional information was received stating the event occurred during testing and there was no patient involved in the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50880195 ↗
• MalfunctionSep 15, 2026Difficult to Insert; Naturally Worn

  It was reported that there was no possibility to put the knife due to damaged bearing. There was no patient impact in this event. Additional information received on evaluation that the bearing was broken.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50768691 ↗
• MalfunctionSep 10, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713945 ↗
• MalfunctionAug 28, 2026Naturally Worn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50491309 ↗
• MalfunctionAug 26, 2026No Apparent Adverse Event

  Patient problems: Insufficient Information

  MAUDE report 50456645 ↗
• MalfunctionAug 25, 2026Corroded; Overheating of Device

  It was reported that the attachment shows signs of rust and tends to overheat during use, which was identified during device testing. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50424040 ↗
• MalfunctionAug 17, 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 reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50269702 ↗
• MalfunctionJul 6, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE ATTACHMENT HAS GENERAL DISSATISFACTION. IT WAS REPORTED THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARING DETACHMENT WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25714253 ↗
• MalfunctionJul 6, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THERE WERE NO ALLEGED ISSUE WITH THE DEVICE. 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 25713439 ↗
• MalfunctionJul 4, 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. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: Insufficient Information

  MAUDE report 25711002 ↗
• MalfunctionJul 4, 2026Difficult to Insert

  IT WAS REPORTED THAT THE ATTACHMENT IS A DIFFICULT-TO-INSERT TOOL. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25709387 ↗
• MalfunctionJul 3, 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 BEARING WAS FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25702407 ↗
• MalfunctionJul 2, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE CUSTOMER HAD GENERAL DISSATISFACTION OVER THE PRODUCT.  NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED AS DETACHED BEARINGS FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25699732 ↗
• MalfunctionJul 2, 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. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25693503 ↗
• MalfunctionJul 2, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST WITH NO ALLEGED PRODUCT DEFICIENCY. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING DETACHED BEARINGS WAS FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25692290 ↗