Midas Rex™ F1/8TA15Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169766235), received between Jul 3, 2018 and May 6, 2022 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE WHILE DOCTOR WAS USING TOOL, IT BROKE OFF. A NEW DRILL BIT WAS OPENED TO THE FIELD AND SOON AFTER FIRST BEING USED THE BIT BROKE OFF AS WELL. A NEW BIT WAS WITH DIFFERENT LOT NUMBER WAS USED TO FINISH THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14309339 ↗
• MalfunctionOct 22, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A CRANIOTOMY PROCEDURE, THE END OF THE CRANIOTOME WAS BROKEN. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. IT WAS ALSO REPORTED THAT THERE WAS NO BROKEN TOOL PIECES LEFT INSIDE THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED USING A BACK-UP PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12685706 ↗
• MalfunctionAug 30, 2019Fracture; Fracture

  IT WAS REPORTED THAT TWO BURRS BROKE DURING THE PROCEDURE. IT WAS CONFIRMED THAT THERE WAS NO PATIENT IMPACT. ON FOLLOW UP, IT WAS CONFIRMED THAT BOTH TOOLS WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8952623 ↗
• MalfunctionJul 27, 2018Break; Fracture; Fracture

  A USER REPORT ISSUED FROM FRENCH COMPONENT AUTHORITY REPORTED THAT THE TOOL SUDDENLY BROKE DURING SPINAL SURGERY. THE BROKEN FRAGMENT OF THE BUR WAS RECOVERED FROM THE PATIENT. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. IT WAS ALSO REPORTED THAT THE DEVICE WAS DISCARDED BY THE HOSPITAL AND NOT AVAILABLE FOR ANALYSIS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7725503 ↗
• InjuryJul 24, 2018Break; Fracture; Detachment of Device or Device Component; Fracture

  IT WAS REPORTED THAT WHEN THE SURGEON WAS DRILLING, THE TIP OF THE CRANIOTOME BROKE OFF IN SMALL PIECES. THE SURGEON REPORTED THAT SHE USED SUCTION TUBING TO REMOVE THE TOOL PIECES. THERE WAS A DELAY DUE TO AN X-RAY THAT WAS CONDUCTED TO VERIFY THE BROKEN PIECES OF TOOL WERE NOT IN THE PATIENT. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. RETRIEVED PIECES OF THE DEVICE WAS DISCARDED AT THE HOSPITAL AND NOT AVAILABLE FOR RETURN.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available; Radiation Exposure, Unintended

  MAUDE report 7716497 ↗
• MalfunctionJul 3, 2018Fracture; Fracture

  IT WAS REPORTED THAT TWO OF THE SAME TYPE OF TOOLS WERE BROKEN WHEN A SUTURE HOLE OF CRANIOTOMY LINE WAS BEING CREATED. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. NO FURTHER INFORMATION WAS OBTAINED UPON FOLLOW UP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7661706 ↗

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)