Midas Rex EM200 (UDI 00763000096649)Recalls & reported problems
Medtronic Powered Surgical Solutions · MOTOR EM200 LEGEND EHS STYLUS ROHS · Class 2
Quick summary
This Medtronic Midas Rex surgical drill motor is an electric drill used in surgery. Its 254 reports mostly describe the motor overheating, sometimes with odd noises, and 247 report no clinical signs in patients. There were no deaths and 7 injuries, and reports fell to 1 in the last 12 months from 105 in the 12 months before. No recalls name this device.
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
- 254
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 254 adverse event reports that list this exact device (DI 00763000096649), received between Jan 2, 2020 and Nov 7, 2025 — classified as 7 injuries, 247 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (245 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 Device245
- No Apparent Adverse Event42
- Noise, Audible16
- Electrical /Electronic Property Problem8
- Intermittent Loss of Power5
- Naturally Worn5
- Device Displays Incorrect Message4
- Detachment of Device or Device Component3
Patient problems
- No Clinical Signs, Symptoms or Conditions247
- Chemical Exposure4
- No Consequences Or Impact To Patient3
- Burn(s)2
- Insufficient Information1
- Perforation1
Recent adverse event reports
The 25 most recent of 254 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 7, 2025Overheating of Device; Device Displays Incorrect Message; Overheating of Device; Device Displays Incorrect Message
IT WAS REPORTED THAT THE DEVICE DISPLAYED ERROR CODE 16 AND EXPERIENCED A HEATING PROBLEM AFTER USE. NO PATIENT INVOLVEMENT, IMPACT, OR ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23497766 ↗MalfunctionAug 12, 2025Overheating of Device; Noise, Audible; Overheating of Device; Noise, Audible
IT WAS REPORTED THAT THE DEVICE HAS WEIRD NOISE AND GET WARM QUICKLY DURING USAGE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22781080 ↗MalfunctionAug 12, 2025Overheating of Device; Noise, Audible; Overheating of Device; Noise, Audible
IT WAS REPORTED THAT THE DEVICE HAS WEIRD NOISE AND GET WARM QUICKLY DURING USAGE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22781055 ↗MalfunctionAug 11, 2025Overheating of Device; Noise, Audible; Overheating of Device; Noise, Audible
IT WAS REPORTED THAT THE DEVICE HAS WEIRD NOISE AND GET WARM QUICKLY DURING USAGE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22770965 ↗MalfunctionAug 11, 2025Overheating of Device; Noise, Audible; Overheating of Device; Noise, Audible
IT WAS REPORTED THAT THE DEVICE HAS WEIRD NOISE AND GET WARM QUICKLY DURING USAGE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22770803 ↗MalfunctionJul 23, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22573812 ↗MalfunctionJun 11, 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 22183407 ↗MalfunctionJun 4, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR THE 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 22139379 ↗MalfunctionMay 19, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVER HEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22042336 ↗MalfunctionApr 17, 2025Overheating of Device; Noise, Audible; Overheating of Device; Noise, Audible
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF DEVICE OVERHEATING AND NOISY. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOL VEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21857817 ↗MalfunctionApr 3, 2025Overheating of Device; Vibration; No Apparent Adverse Event; Overheating of Device; Vibration; No Apparent Adverse Event
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF VIBRATION AND NOT WORKING PROPERLY AND OVERHEATING. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21766299 ↗MalfunctionMar 26, 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 21704437 ↗MalfunctionMar 26, 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 21700112 ↗MalfunctionMar 26, 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 21695221 ↗MalfunctionMar 26, 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 21694578 ↗MalfunctionMar 25, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED. ON FOLLOW UP IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21685875 ↗MalfunctionMar 24, 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 21675461 ↗MalfunctionMar 24, 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 21675447 ↗MalfunctionMar 24, 2025Overheating of Device; Loss of Power; No Apparent Adverse Event; Overheating of Device; Loss of Power; No Apparent Adverse Event
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING AND LOSS OF POWER. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. REPAIR ESCALATED TO A PRODUCT EVENT DUE TO CUSTOMER INDICATES REPORT IS A COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21674680 ↗MalfunctionMar 21, 2025Overheating of Device; Vibration; Overheating of Device; Vibration
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF DRILL IS VIBRATING AND OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21665338 ↗MalfunctionMar 21, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED. ON FOLLOW UP IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21661267 ↗MalfunctionMar 20, 2025Overheating of Device; Naturally Worn; Overheating of Device; Naturally Worn
IT WAS REPORTED THAT BEARING PROBLEMS, THE HANDPIECE OVERHEATS. THERE WAS NO PATIENT INVOLVED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21652939 ↗MalfunctionMar 18, 2025Overheating of Device; Naturally Worn; Overheating of Device; Naturally Worn
IT WAS REPORTED THAT IT HAS BEARING PROBLEMS, THE HANDPIECE OVERHEATS. THERE WAS NO PATIENT INVOLVED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21631895 ↗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 21630249 ↗MalfunctionMar 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 OR STAFF IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21616938 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.