Midas Rex® PM100-RRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994422040), received between Feb 3, 2020 and Jan 12, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (2 reports).

9 other recalls cover devices cleared under the same FDA submission (K020069); they may or may not involve this specific model.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 12, 2023Electrical /Electronic Property Problem; Material Rupture; Gas/Air Leak; Electrical /Electronic Property Problem; Material Rupture; Gas/Air Leak

  IT WAS REPORTED THAT DURING THE FIRST RIB REMOVAL TO DECOMPRESS BLOOD VESSEL  PROCEDURE, THE DRILL DID NOT WORK AND IT WAS FOUND THAT DRILL HOSE HAD AN INTERNAL LEAK OR THAT THE DIFFUSER HOSE SEAL HAD RUPTURED. IT WAS ALSO REPORTED THAT THERE WAS A DELAY IN PROCEDURE FOR 90 MINUTES FOR BRINGING UP THE BACKUP DEVICE FROM OTHER FACILITY AND THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT RECEIVED. ON FOLLOW UP IT WAS REPORTED THAT THE DEVICE DID NOT COME IN CONTACT WITH PATIENT. PATIENT WAS ASLEEP, AND THEY HAD A PROLONGED ANESTHESIA OF 60-90 MINUTES WHILST A NEW DRILL WAS SOURCED FROM A LOCAL HOSPITAL.

  Patient problems: Chemical Exposure; Oversedation

  MAUDE report 16143721 ↗
• InjuryAug 23, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT WHILE USING THE DEVICE, THE HOSE EXPLODED IN THE SURGEONS HAND. IT WAS ALSO REPORTED THAT THE DEVICE WAS SET ASIDE AND A BACKUP DEVICE WAS USED TO COMPLETE THE SURGERY. ADDITIONAL INFORMATION ABOUT THE EVENT IS BEING FOLLOWED UP FROM THE FACILITY CONTACT PERSON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12356934 ↗
• InjuryFeb 3, 2020Electrical /Electronic Property Problem; Loss of Power; Electrical /Electronic Property Problem; Loss of Power

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF NOT WORKING AND HAS POOR AIR FLOW. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT BUT THERE WAS PROLONGED EXPOSURE TO ANESTHESIA AND PROCEDURE DELAY TO GET ANOTHER DRILL. REPAIR REQUEST ESCALATED TO PRODUCT EVENT DUE TO CUSTOMER INDICATION THAT THIS REPORT IS A COMPLAINT.

  Patient problems: Chemical Exposure

  MAUDE report 9661569 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K020069. One submission often covers many models, so check the product and lot details in each record.

• Z-1602-2016 · Apr 8, 2016 · Terminated
  Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.
• Z-0321-2016 · Oct 21, 2015 · Terminated
  Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by surgeons to drill holes.
• Z-0546-2010 · Nov 30, 2009 · Terminated
  Medtronic Midas Rex Legend Footed Attachment, AF01. Intended for use with all Legend and Legend EHS motors for general surgery including maxillofacial , craniofacial and sternotom
• Z-2156-2008 · May 30, 2008 · Terminated
  Medtronic Midas Rex Legend tapered dissecting tool, Model F2/8TA23 Medtronic Powered Surgical Solutions, Forth Worth, TX Intended for use in Spinal, Cranial, Orthopedic, General S
• Z-1574-05 · Sep 1, 2005 · Terminated
  Medtronic Midas Rex Classic, GS and Legend dissecting tools manufactured by Medtronic Inc. Powered Surgical Solutions, 4620 North Beach Street, Fort Worth, tX 76137 USA, Rx only, S
• Z-1067-05 · Jun 29, 2005 · Terminated
  Medtronic MIDAS REX Legend High Speed Pneumatic System, Gold Touch Motor. Manufactured by Medtronic, Inc. Powered Surgical Solutions, 4620 North Beach Street, Fort Worth, TX 76137
• Z-0278-05 · Nov 11, 2004 · Terminated
  Medtronic Midas Rex Legend High Speed Pneumatic System
• Z-0213-05 · Nov 3, 2004 · Terminated
  Medtronic Midas Rex Legend Lubricant/ Diffuser Cartridge Catalog number PA100-A, manufactured by Medtronic Powered Surgical Solutions, Fort Worth, Texas
• Z-0419-03 · Nov 11, 2002 · Terminated
  Legend Lubricant System (Legend Gold, Gold Touch and Platinum motors and Legend Lubricant/Diffuser cartridge)