MIDAS REX MR8 MR8-9MC30Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000506742), received between Dec 16, 2022 and Aug 22, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE TOOL BROKE WHILE CUTTING METAL DURING A PROCEDURE. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. IT WAS ALSO REPORTED THAT THE EVENT RESULTED IN A 10-MINUTE PROCEDURE DELAY, AND THE PROCEDURE WAS COMPLETED USING BACKUP PRODUCT(S).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22870423 ↗
• InjuryJan 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE LEFT TOTAL HIP ARTHROPLASTY (LEFT) WHILE TRYING TO REMOVE THE SCREWS FROM THE PATIENT BODY, TOOL GOT SHEARED OFF AND THE SLEEVE OF THE SCREW WAS SEPARATED. IT WAS REPORTED THAT X-RAY WAS PERFORMED TO CONFIRM THE BROKEN PIECES WERE REMOVED FROM THE FIELD AND THERE WAS NO UNEXPECTED FINDINGS. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT HARM WAS OCCURRED. ADDITIONAL INFORMATION REGARDING THE EVENT WAS BEING FOLLOWED-UP.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 16155581 ↗
• MalfunctionDec 16, 2022Break; Detachment of Device or Device Component

  SURGEON NEEDED TO REMOVE SCREWS THAT PATIENT PREVIOUSLY HAD FROM WHEN HE WAS YOUNGER. WHILE TRYING TO REMOVE SCREWS A MIDAS REX METAL CUTTING BURR SHEARED OFF WHILE BEING USED AS WELL AS A SLEEVE FROM SYNTHES BROKEN SCREW REMOVAL SET. X-RAY NOTIFIED, BROKEN PIECES REMOVED FROM FIELD. X-RAYS TAKEN - RADIOLOGIST CONFIRMED NO UNEXPECTED FINDINGS. SURGEON EVALUATED AND REVIEWED FILMS AS WELL. NO HARM TO THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15995131 ↗