MIDAS REX MR8 PM810 (UDI 00763000431037)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000431037), received between Jun 28, 2024 and Jun 5, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Remains Activated” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT DEVICE, AIR LEAK. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25405635 ↗
• MalfunctionAug 4, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DEVICE CONTINUES RUNNING SLOWLY AFTER FINGER REMOVED FROM FINGER SWITCH AS REMOVING FROM PATIENT. DRILL HAD BECOME STUCK IN BONE. WHEN PULLED TO REMOVE DRILL AND IT CONTINUES TO SPIN. CAUGHT HIS GLOVE ON THE WAY OUT AND TORE A HOLE. IT WAS REPORTED THAT SURGEON ALSO RECEIVED SUPERFICIAL SCRAPE ON SKIN, BUT NO INJURY OTHER THAN SUPERFICIAL SCRAPE ON SKIN/HAND. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. THERE WAS A DELAY OF 10 MINUTES AS A RESULT OF THIS EVENT. THE PROCEDURE WAS COMPLETED WITH THE BACKUP PRODUCT. NO ADDITIONAL INTERVENTION WAS PERFORMED OR PLANNED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22698071 ↗
• MalfunctionJun 5, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE TRIGGER FINGER SWITCH CONTINUES TO GET STUCK AND WILL CONTINUE TO RUN EVEN WHEN NOT MANUALLY HOLDING IT DOWN. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22148400 ↗
• MalfunctionJan 9, 2025Device Remains Activated; Device Remains Activated

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF CONTINUES TO RUN. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT DUE TO RETURN IN LESS THAN 90 DAYS FROM PURCHASE OR REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21109544 ↗
• MalfunctionJun 28, 2024Unintended System Motion; Unintended System Motion

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF UNINTENDED SYSTEM. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19633198 ↗