Midas Rex MR8 EM800 (UDI 00643169912106)Recalls & reported problems
Medtronic Powered Surgical Solutions · MOTOR EM800 MR8 ELECTRIC · Class 2
Quick summary
This Midas Rex MR8 surgical drill motor is an electric motor used in surgery. Most reports describe the motor overheating, often found during pre-use checks with no patient involved. The 158 reports include no deaths and 2 injuries. No recalls name this device, and reports fell from 66 in the prior 12 months to 2 in the latest 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 158
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 158 adverse event reports that list this exact device (DI 00643169912106), received between Aug 10, 2021 and Dec 8, 2025 — classified as 2 injuries, 156 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (145 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.
Reports received per month
Most reported problems
Device problems
- Overheating of Device145
- No Apparent Adverse Event14
- Loss of Power8
- Detachment of Device or Device Component7
- Difficult to Insert5
- Electrical /Electronic Property Problem5
- Noise, Audible4
- Device Displays Incorrect Message3
Patient problems
- No Clinical Signs, Symptoms or Conditions153
- Insufficient Information4
- Burn(s)2
- Erythema1
Recent adverse event reports
The 25 most recent of 158 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 8, 2025Naturally Worn; Naturally Worn
IT WAS REPORTED THAT, DURING PRE-OPERATIVE PREPARATION FOR USE, THE DEVICE WAS OBSERVED TO BE WORN, WITH RUST AND CORROSION PRESENT. THE ISSUE WAS IDENTIFIED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23742597 ↗MalfunctionDec 4, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE MOTOR WAS OVERHEATING. NO PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DURING PRE-OP, IT WAS REPORTED THAT WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23724093 ↗MalfunctionSep 17, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23074193 ↗MalfunctionJul 29, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22660974 ↗MalfunctionJul 28, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE MOTOR ON THE HANDPIECE IS OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22629717 ↗MalfunctionJul 4, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. THERE WAS NO PATIENT INVOLVEMENT. REPAIR IS BEING ESCALATED TO PRODUCT EVENT DUE TO REASON FOR THE RETURN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22401849 ↗MalfunctionMay 13, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22010583 ↗MalfunctionMay 9, 2025Overheating of Device; Device Displays Incorrect Message; Overheating of Device; Device Displays Incorrect Message
IT WAS REPORTED THAT DEVICE OVERHEATING AND ERROR CODE DISPLAYED. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21992304 ↗MalfunctionApr 20, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE DEVICE WAS OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21870189 ↗MalfunctionApr 3, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21759709 ↗MalfunctionApr 2, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21750709 ↗MalfunctionApr 1, 2025Overheating of Device; Smoking; Overheating of Device; Smoking
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING AND SMOKE. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21738008 ↗MalfunctionMar 26, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE DEVICE WAS OVERHEATING. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21695278 ↗MalfunctionMar 25, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21685215 ↗MalfunctionMar 24, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT DUE TO RETURN IN LESS THAN 90 DAYS FROM PURCHASE OR REPAIR.
Patient problems: Insufficient Information
MAUDE report 21674682 ↗MalfunctionMar 20, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED.
Patient problems: Insufficient Information
MAUDE report 21649853 ↗MalfunctionMar 18, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21629737 ↗MalfunctionMar 18, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21629666 ↗MalfunctionMar 18, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21629357 ↗MalfunctionMar 18, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21629231 ↗MalfunctionMar 17, 2025Overheating of Device; Noise, Audible; Overheating of Device; Noise, Audible
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING AND NOISE. NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21616683 ↗MalfunctionMar 17, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21615705 ↗MalfunctionMar 14, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21602992 ↗MalfunctionMar 13, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21592825 ↗MalfunctionMar 12, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. REPAIR IS BEING ESCALATED TO PRODUCT EVENT DUE TO REASON FOR THE RETURN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21581595 ↗
Other MOTOR, DRILL, ELECTRIC devices
- NA CRANI-A-G1Synthes GmbH · MOTOR, DRILL, ELECTRIC1 recall358 reports
- NA QD8Synthes GmbH · MOTOR, DRILL, ELECTRIC386 reports
- NA QD11-G1Synthes GmbH · MOTOR, DRILL, ELECTRIC312 reports
- Midas Rex EM200Medtronic Powered Surgical Solutions · MOTOR, DRILL, ELECTRIC254 reports
- MIDAS REX MR8 EM800Medtronic Powered Surgical Solutions · MOTOR, DRILL, ELECTRIC186 reports
- NA SHORT-G1Synthes GmbH · MOTOR, DRILL, ELECTRIC134 reports
- Midas Rex® EM200Medtronic Powered Surgical Solutions · MOTOR, DRILL, ELECTRIC123 reports
- NA CRANI-P-G1Synthes GmbH · MOTOR, DRILL, ELECTRIC1 recall62 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.