Midas Rex™ F2/8TA23SRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00643169766266), received between Aug 1, 2018 and Apr 2, 2021 — classified as 3 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Fracture” (19 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A CRANIOTOMY PROCEDURE, THE TOOL WAS BROKEN. IT WAS REPORTED THAT THERE WAS A 10-MINUTE PROCEDURE DELAY AND THE PROCEDURE WAS COMPLETED USING A BACKUP DEVICE. IT WAS ALSO REPORTED THAT THERE WAS NO BROKEN PIECES OF THE TOOL REMAINED INSIDE THE PATIENT'S BODY. ON FOLLOW-UP, IT WAS REPORTED THAT THE DELAY ON THE PROCEDURE WAS TO REMOVE THE BROKEN PART WITH FORCEPS. IT WAS ALSO REPORTED THAT THERE WAS NO UNPLANNED PROCEDURE TAKEN BECAUSE OF THE EVENT AND THERE WAS NO FURTHER INFORMATION REGARDING THE STATUS OF THE PATIENT POST-SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11611148 ↗
• MalfunctionApr 2, 2021Fracture; Fracture

  ON FURTHER FOLLOW-UP, IT WAS CONFIRMED THAT THERE WAS NO PATIENT OR STAFF IMPACT. IT WAS ALSO REPORTED THAT THERE WAS A 3-5 MINUTE PROCEDURE DELAY TO PREPARE A BACKUP DEVICE. IT WAS ALSO CONFIRMED THAT THE PATIENT HAD NO FURTHER ISSUES POST-SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11610991 ↗
• MalfunctionAug 23, 2019Fracture; Fracture

  IT WAS REPORTED THAT TOOL BROKE DURING CRANIOTOMY. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. ADDITIONAL INFORMATION REGARDING PRODUCT RETURN IS BEING FOLLOWED UP FROM THE CONTACT PERSON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8928359 ↗
• MalfunctionAug 14, 2019Fracture; Fracture

  IT WAS REPORTED THAT FIVE TOOLS WERE BROKEN DURING A CRANIOTOMY PROCEDURE. ON FOLLOW-UP, IT WAS CONFIRMED THAT THERE WAS NO PATIENT OR STAFF IMPACT. ADDITIONAL INFORMATION IS BEING REQUESTED REGARDING PRODUCT RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8895679 ↗
• MalfunctionAug 7, 2019Fracture; Fracture

  IT WAS REPORTED THAT SIX TOOLS OF THE SAME LOT NUMBER WERE BROKEN IN THE SAME SURGERY. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8870715 ↗
• InjuryJul 22, 2019Fracture; Fracture

  IT WAS REPORTED THAT DURING CRANIOTOMY, THE DRILL BIT BROKE AND ALL PARTS OF THE TOOL WERE FOUND INSIDE THE PATIENT. THE PATIENT WAS ALIVE WITH NO INJURY HOWEVER THERE WAS A DELAY IN PROCEDURE DUE TO REMOVAL OF FRAGMENTS AND USE OF A BACK UP DEVICE. A NEW DRILL BIT WAS OPENED HOWEVER THE BARREL WAS FOUND TO BE DAMAGED. ADDITIONAL INFORMATION IS BEING REQUESTED REGARDING THE EVENT AND PRODUCT RETURN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8810927 ↗
• MalfunctionJul 11, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE TOOL WAS BROKEN. NO PATIENT IMPACT WAS REPORTED. IT WAS ALSO MENTIONED THAT THE TOOL WAS DISCARDED AND WILL NO LONGER BE AVAILABLE FOR RETURNED. ADDITIONAL INFORMATION IS BEING REQUESTED REGARDING THE EVENT AND PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8781835 ↗
• MalfunctionJul 11, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE TOOL WAS BROKEN. NO PATIENT IMPACT WAS REPORTED. IT WAS ALSO MENTIONED THAT THE TOOL WAS DISCARDED AND WILL NO LONGER BE AVAILABLE FOR RETURNED. ADDITIONAL INFORMATION IS BEING REQUESTED REGARDING THE EVENT AND PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8781801 ↗
• MalfunctionJul 11, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE TOOL WAS BROKEN. NO PATIENT IMPACT WAS REPORTED. IT WAS ALSO MENTIONED THAT THE TOOL WAS DISCARDED AND WILL NO LONGER BE AVAILABLE FOR RETURNED. ADDITIONAL INFORMATION IS BEING REQUESTED REGARDING THE EVENT AND PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8781780 ↗
• MalfunctionJul 11, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE TOOL WAS BROKEN. NO PATIENT IMPACT WAS REPORTED. IT WAS ALSO MENTIONED THAT THE TOOL WAS DISCARDED AND WILL NO LONGER BE AVAILABLE FOR RETURNED. ADDITIONAL INFORMATION IS BEING REQUESTED REGARDING THE EVENT AND PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8781740 ↗
• MalfunctionJul 11, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE TOOL WAS BROKEN. NO PATIENT IMPACT WAS REPORTED. IT WAS ALSO MENTIONED THAT THE TOOL WAS DISCARDED AND WILL NO LONGER BE AVAILABLE FOR RETURN. ADDITIONAL INFORMATION IS BEING REQUESTED REGARDING THE EVENT AND PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8781701 ↗
• MalfunctionJul 11, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE TOOL WAS BROKEN. NO PATIENT IMPACT WAS REPORTED. IT WAS ALSO MENTIONED THAT THE TOOL WAS DISCARDED AND WILL NO LONGER BE AVAILABLE FOR RETURN. ADDITIONAL INFORMATION IS BEING REQUESTED REGARDING THE EVENT AND PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8781648 ↗
• InjuryJun 21, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE BUR SNAPPED INSIDE THE CRANIOTOME ATTACHMENT DURING THE CRANIOTOMY. IT WAS STATED THAT THERE WAS NO PATIENT IMPACT. ON FOLLOW-UP, IT WAS CONFIRMED WITH THE HCP THAT THERE WAS A 10 MINUTE DELAY DUE TO THE EVENT AND THAT AN X-RAY WAS PERFORMED TO CHECK FOR CRANIOTOME FRAGMENTS. IT WAS VERIFIED THAT THE PATIENT HAD NO FURTHER ISSUES POST-SURGERY. ADDITIONAL INFORMATION IS CURRENTLY BEING REQUESTED REGARDING PRODUCT RETURN AND X-RAY RESULTS.

  Patient problems: No Consequences Or Impact To Patient; Radiation Exposure, Unintended

  MAUDE report 8723036 ↗
• MalfunctionJun 19, 2019Fracture; Fracture

  IT WAS REPORTED THAT WHILE THE HEALTHCARE PROFESSIONAL WAS PERFORMING CRANIOTOMY, THE CRANIOTOME BUR SNAPPED. NO PATIENT IMPACT REPORTED. ON FOLLOW UP, IT WAS REPORTED AND CONFIRMED WITH HCP THAT THERE WAS A 30 MINUTE DELAY DURING THE PROCEDURE. THERE WAS A NEED TO PERFORM AN ADDITIONAL X-RAY PROCEDURE AS A RESULT OF THE EVENT. PATIENT IS CURRENTLY DOING WELL.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 8711693 ↗
• MalfunctionMay 17, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE TOOL BROKE DURING SURGERY. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION ABOUT THE EVENT IS CURRENTLY BEING FOLLOWED UP FOR FURTHER DETAILS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8621644 ↗
• MalfunctionMay 6, 2019Fracture; Fracture

  IT WAS REPORTED THAT WHEN CUTTING THE SKULL BONE, THE WICK BROKE CLEANLY. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8583111 ↗
• MalfunctionFeb 26, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE BURR SPLIT IN HALF DURING THE PROCEDURE. ON FOLLOW-UP, IT WAS CONFIRMED THAT THAT THERE WAS NO INJURY OR HARM TO THE PATIENT BUT THERE WAS A MINIMAL DELAY DUE TO THE BURR REPLACEMENT. IT WAS ALSO CONFIRMED THAT THERE WERE NO ADDITIONAL ACTIONS TAKEN AFTER SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8369674 ↗
• MalfunctionAug 5, 2018Break; Fracture; Fracture

  IT WAS REPORTED DURING SURGERY, THE TOOL TIP BROKE OFF WHEN CUTTING THE SKULL BONE FLAP. IT WAS REPORTED THERE WAS NO PATIENT INJURY AND THE DEVICE WAS DISCARDED AT THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7749913 ↗
• InjuryAug 1, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT THE CRANIOTOME BURR SNAPPED DURING A TRAUMA CRANIOTOMY CASE AND DAMAGED THE PATIENT'S DURA. THERE WAS A MINOR DELAY TO CHANGE OUT THE BURR FOR ANOTHER PRODUCT AND THE OPERATION COMPLETED WITH NO OTHER INCIDENT. ADDITIONAL INFORMATION IS BEING REQUESTED ON THE PATIENT'S CURRENT CONDITION AND RETURN OF THE DEVICE FOR ANALYSIS.

  Patient problems: Injury; Perforation

  MAUDE report 7740782 ↗

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)