Midas Rex™ F2/8TA23Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00643169766259), received between Apr 6, 2017 and Jul 14, 2022 — classified as 4 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Fracture” (16 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2022Fracture; Difficult to Remove; Fracture; Difficult to Remove

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF TOOL STUCK IN THE ATTACHMENT. NO PATIENT IMPACT REPORTED. REPAIR ESCALATED TO PRODUCT EVENT ON EVALUATION DUE TO BROKEN TOOL. ADDITIONAL INFORMATION REGARDING THE PATIENT IMPACT AND EVENT WAS BEING FOLLOWED UP. DATE OF EVENT NOTIFIED: ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15013092 ↗
• MalfunctionJul 12, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A CRANIOTOMY AND REMOVAL OF FLAP PROCEDURE, THE TOOL WAS BROKEN INTO THREE PIECES. IT WAS REPORTED THAT THE SURGEON WAS ABLE TO REMOVE THE TWO BROKEN PIECES AND THE THIRD ONE WAS SUCTIONED. IT WAS ALSO REPORTED THAT THERE WAS NO X-RAY PROCEDURE PERFORMED AS ALL THE BROKEN PIECES WERE REMOVED, THERE WAS NO PROCEDURE DELAY, AND THE PROCEDURE WAS COMPLETED WITH THE BACKUP PRODUCT. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. ON FOLLOW-UP, IT WAS CONFIRMED THAT THE PATIENT HAD NO FURTHER ISSUES POST-SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12155217 ↗
• MalfunctionSep 11, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A CASE, THE TOOL WAS BROKEN. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT AND THE BROKEN PIECES WERE RETRIEVED. ON FOLLOW UP, IT WAS REPORTED THAT THE EVENT HAPPENED DURING A CRANIOTOMY PROCEDURE FOR A TUMOR AND THE SURGERY WAS COMPLETED WITHOUT ANY DELAY OR UNPLANNED PROCEDURE. IT WAS ALSO ADDED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE STATUS OF THE PATIENT POST-SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10521045 ↗
• MalfunctionApr 23, 2020Fracture; Fracture

  IT WAS REPORTED THAT FOUR OF THE CUTTERS WERE FRACTURED, AND OTHER FOUR COULD NOT BE INSTALLED BUT COULD BE REVERSELY INSERTED INTO THE ACCESSORIES OF THE MILLING CUTTER. IT WAS ALSO ADDED THAT THE TOOLS WILL NOT BE RETURNED. NO PATIENT IMPACT REPORTED.

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

  MAUDE report 9990100 ↗
• MalfunctionMar 2, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE TOOL WAS BROKEN DURING CRANIOTOMY. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 9777347 ↗
• InjuryJan 15, 2020No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THERE WAS DIFFICULTY IN DOING A CRANIOTOMY PROCEDURE. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT BUT BLOOD LOSS WAS NOTED. ADDITIONAL INFORMATION ABOUT THE EVENT IS BEING FOLLOWED UP FROM THE FACILITY CONTACT PERSON.

  Patient problems: Blood Loss

  MAUDE report 9590633 ↗
• MalfunctionNov 7, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF THE TOOL WAS BROKEN DURING A CRANIOTOMY PROCEDURE. IT WAS ALSO NOTED THAT THERE WAS A 10-MINUTE DELAY ON THE PROCEDURE. ON FOLLOW UP, IT WAS CONFIRMED THAT THERE WAS NO PATIENT OR STAFF IMPACT, THE PATIENT HAD NO FURTHER ISSUES POST SURGERY AND THE 10-MINUTE DELAY WAS DUE TO TOOL REPLACEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9289505 ↗
• MalfunctionJul 19, 2019Fracture; Fracture

  IT WAS REPORTED THAT TOOL BROKE DURING A CRANIOTOMY. IT WAS CONFIRMED THAT THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION IS BEING REQUESTED REGARDING PRODUCT RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8809708 ↗
• MalfunctionMar 21, 2019Fracture; Fracture

  IT WAS REPORTED THAT A BUR SNAPPED WHILE BEING USED IN A PROCEDURE. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. IT WAS ALSO REPORTED THAT THE PATIENT WAS ALIVE WITH NO INJURY. UPON FOLLOW UP, IT WAS REPORTED THAT THERE WAS A 20-MINUTE DELAY DUE TO THE USE OF ANOTHER BLADE WHICH CAUSED PROLONGED ANESTHETIC USE. IT WAS CONFIRMED THAT THE INCIDENT DID NOT CAUSE ANY LONG TERM HARM TO THE PATIENT AND THE SURGERY WAS COMPLETED WITH NO OTHER NON-ROUTINE ACTIVITIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8439301 ↗
• InjuryNov 28, 2018Fracture; Fracture

  IT WAS REPORTED THAT THE TOOL BROKE OFF WHILE OPENING A FLAP DURING OPERATION. THE PATIENT WAS X-RAYED AND THE TOOL FRAGMENT WAS LOCATED AND REMOVED. ON FOLLOW-UP, IT WAS CONFIRMED THAT THE PATIENT HAD NO INJURY RELATED TO THIS EVENT.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 8110027 ↗
• MalfunctionNov 2, 2018Fracture; Fracture

  IT WAS REPORTED THAT THE TOOL WAS BROKEN IN HALF DURING THE SURGERY. A BACK-UP TOOL WAS USED TO CONTINUE THE PROCEDURE. ON FOLLOW-UP, IT WAS CONFIRMED THAT THERE WAS NO PATIENT OR STAFF IMPACT AND THE BROKEN PIECE OF TOOL WAS RETRIEVED FROM THE SAME OPERATION, AND THERE WAS NO NEED TO PERFORM ADDITIONAL/NON-ROUTINE ACTIONS TO LOCATE THE BROKEN PIECE OF TOOL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8033030 ↗
• MalfunctionAug 10, 2018Break

  PT UNDERGOING CRANIOTOMY WHEN DRILL BIT BROKE.

  Patient problems: No Information

  MAUDE report 7772101 ↗
• InjuryMar 2, 2018Fracture; Fracture

  IT WAS REPORTED DURING SURGERY THAT THE TIP BROKE OFF THE DEVICE. IT WAS STATED THERE WAS PATIENT IMPACT; HOWEVER, IT WAS REPORTED THAT THERE WAS NO ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING PATIENT IMPACT AND ADDITIONAL INFORMATION IS CURRENTLY BEING REQUESTED.

  Patient problems: Injury

  MAUDE report 7310822 ↗
• MalfunctionNov 27, 2017Fracture; Fracture

  IT WAS REPORTED THAT THE TOOL BROKE DURING USE. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. ON FOLLOW UP WITH THE FACILITY IT WAS CONFIRMED THERE WERE TWO TOOLS, HOWEVER, THEY WERE USED IN SEPARATE OCCASIONS. IT WAS REPORTED THE PATIENT IS WELL. IT WAS ALSO REPORTED THE EVENT DATE WAS NOT AVAILABLE. THE LOT NUMBER WAS CONFIRMED. THE USER NAME AND INITIAL REPORTER NAMES WERE ALSO PROVIDED. IT WAS REPORTED THE TOOL WOULD BE RETURNED. THE SERIAL NUMBER OF THE AF02 ATTACHMENT USED WITH THE TOOL WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7061219 ↗
• MalfunctionNov 27, 2017Fracture; Fracture

  IT WAS REPORTED THAT THE TOOLS BROKE DURING USE. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. ON FOLLOW UP WITH THE FACILITY IT WAS CONFIRMED THERE WERE TWO TOOLS, HOWEVER, THEY WERE USED IN SEPARATE OCCASIONS. IN THIS EVENT, THE TOOL BROKE WHILE CUTTING THE SKULL BONE. THE TOOL WAS STUCK AND IT BROKE WHEN TRYING TO ADVANCE THE CUTTING. IT WAS REPORTED THE TOOL WOULD BE RETURNED. THE SERIAL NUMBER OF THE AF02 ATTACHMENT USED WITH THE TOOL WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7061112 ↗
• InjuryAug 21, 2017Fracture; Fracture

  A MEDWATCH FORM ((B)(4)) WAS RECEIVED WITH THE FOLLOWING DETAILS: "WHEN THIS SIDE-CUTTING BUR WAS BEING USED TO REMOVE THE BONE FLAP DURING A CRANIOTOMY, THE TOP PORTION ABOUT 2CM OF THE BUR BROKE OFF AND FLEW OUT OF VIEW. THE REMAINING PIECE WAS REMOVED FROM THE MIDAS REX ATTACHMENT AND REPLACED, AND THE CRANIOTOMY PROCEEDED UNEVENTFULLY. THE MISSING PART OF THE BUR COULD NOT BE FOUND AFTER SEARCHING THE FIELD AND THE SURROUNDING FLOOR, SO DURING THE CASE, C ARM WAS CALLED INTO THE ROOM. THE BROKEN PIECE WAS LOCATED IN THE OPERATIVE FIELD BY C ARM VISUALIZATION." ON FOLLOW UP THE EVENT DATE AND PHYSICIAN'S INFORMATION WERE PROVIDED. IT WAS REPORTED THAT THIS WAS THE INITIAL USE OF THE TOOL. THERE WAS NO SIGNIFICANT DELAY IN THE PROCEDURE WHILE CHANGING THE BUR. IT WAS CONFIRMED THAT THE BROKEN OFF PIECE WAS FOUND BY THE C-ARM VISUALIZATION ON THE OPERATIVE FIELD WHILE THE PATIENT WAS PRESENT. ADDITIONAL PATIENT INFORMATION WAS PROVIDED. IT WAS ALSO REPORTED THE PATIENT HAD EXPIRED SINCE THE PROCEDURE FOR REASONS UNRELATED TO THIS EVENT. PARTIAL CONCOMITANT INFORMATION WAS PROVIDED FOR THE AF02 ATTACHMENT.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 6807019 ↗
• MalfunctionJun 29, 2017Fracture; Fracture

  IT WAS REPORTED THAT DISSECTING TOOL BROKE DURING A PROCEDURE. X-RAY WAS COMPLETED TO RETRIEVE THE BROKEN PIECE. THERE WAS NO PATIENT IMPACT. ON FOLLOW UP THE INITIAL REPORTERS NAME WAS PROVIDED. THE SURGICAL PROCEDURE WAS A CRANIOTOMY FOR SUBDURAL. IT WAS CONFIRMED THERE WAS A 30 MINUTE DELAY IN THE PROCEDURE TO RETRIEVE A NEW TOOL AND DRILL, AND X-RAY THE PATIENT TO RETRIEVE THE BROKEN TOOL. SOME PATIENT INFORMATION WAS ALSO PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6676659 ↗
• MalfunctionApr 6, 2017Fracture; Fracture

  IT WAS REPORTED THE DISSECTING TOOL FRACTURED WHEN INITIALLY TURNING THE CRANIAL FLAP. IT WAS REPORTED THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. REPORT WAS ESCALATED TO A PRODUCT EVENT DUE TO THE REPORTED MALFUNCTION. THE SURGEON REPLACED THE TOOL WITH ANOTHER TOOL OF THE SAME MODEL AND HAD NO OTHER ISSUE. ON FOLLOW UP THE PHYSICIAN AND INITIAL REPORTERS CONTACT INFORMATION WAS PROVIDED. NO ADDITIONAL INFORMATION WAS AVAILABLE FOR THE ATTACHMENT THAT WAS USED WITH THE TOOL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6463973 ↗

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)