MIDAS REX MR8 MR8-ASMC09 (UDI 00763000441173)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00763000441173), received between Apr 2, 2025 and Jul 4, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (9 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 4, 2026Difficult to Remove

  IT WAS REPORTED THAT DURING POST OPERATION DRILL BIT STUCK. AT THE TIME OF REPORT THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT SEIZED DISTAL BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25709728 ↗
• MalfunctionJun 23, 2026Difficult to Remove

  IT WAS REPORTED THAT DURING PRE-OP THE DRILL BIT GOT STUCK . AT THE TIME OF REPORT NO PATIENT OR STAFF IMPACT IS BEEN OBSERVED . ADDITIONAL INFORMATION RECEIVED THAT BEARINGS WERE SEIZED DURING EVALUATION .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25590813 ↗
• MalfunctionJun 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DEVICE WAS SENT IN FOR SCHEDULED PREVENTIVE MAINTENANCE. THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25487228 ↗
• MalfunctionJun 11, 2026Overheating of Device

  IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE, THE ATTACHMENT TEMPERATURE INCREASES. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25470115 ↗
• MalfunctionJun 11, 2026Difficult to Insert

  IT WAS REPORTED THAT DURING SERVICING, THE ATTACHMENT WAS DIFFICULT TO MOUNT OR ATTACH. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25466943 ↗
• MalfunctionMay 29, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE BEARING WAS FELL OUT. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25326693 ↗
• MalfunctionMay 27, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO USE, THE ATTACHMENT BEARING WAS DETACHED. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25300660 ↗
• MalfunctionMay 22, 2026Difficult to Insert

  IT WAS REPORTED PRE-OPERATIVELY THAT IT WAS DIFFICULT TO INSERT THE TOOL/BLADE INTO THE ATTACHMENT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25256760 ↗
• MalfunctionMay 22, 2026Overheating of Device

  IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE, A TEMPERATURE INCREASE WAS OBSERVED IN THE ATTACHMENT. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED ON EVALUATION STATING THAT DISTAL BEARING WAS MISALIGNED MADE THIS EVENT REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25252455 ↗
• MalfunctionApr 27, 2026Overheating of Device

  IT WAS REPORTED THAT DEVICE TEMPERATURE INCREASED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24994390 ↗
• MalfunctionFeb 4, 2026Naturally Worn

  IT WAS REPORTED THAT THE DEVICE WITH THE REPORT OF BEARING FAILED. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257097 ↗
• MalfunctionNov 7, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE MOTOR WAS OVERHEATING. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23504343 ↗
• MalfunctionNov 7, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT WAS ALLEGED TO HAVE ISSUES OF OVERHEATING, RUNNING HOT, AND HEATING UP. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION STATES THAT THE ISSUE WAS IDENTIFIED BEFORE SERVICE AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23494594 ↗
• MalfunctionNov 7, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT WAS OVERHEATING. AT THE TIME OF THE REPORT, THERE WAS NO KNOWN IMPACT TO A PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 23494097 ↗
• MalfunctionNov 7, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT OVERHEATING. AT THE TIME OF THE REPORT, THERE WAS NO KNOWN IMPACT TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 23494092 ↗
• MalfunctionNov 3, 2025Overheating of Device; Overheating of Device

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

  Patient problems: Insufficient Information

  MAUDE report 23448160 ↗
• MalfunctionApr 2, 2025Overheating of Device; Device Displays Incorrect Message; Overheating of Device; Device Displays Incorrect Message

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING AND ERROR MESSAGE GIVEN. NO PATIENT IMPACT REPORTED. ON FOLLOW-UP IT WAS REPORTED THAT THERE WERE NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21750307 ↗