Midas Rex ™ 8TA11Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169765689), received between Jan 17, 2019 and Aug 7, 2020 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2020Fracture; Fracture

  IT WAS REPORTED THAT 2 TOOLS WERE BROKEN DURING THE PROCEDURE. IT WAS ALSO ADDED THAT THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE WITH NO DELAY.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 10380210 ↗
• MalfunctionFeb 27, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF THE TOOL WAS BROKEN AFTER USE. IT WAS ALSO ADDED THAT THE BROKEN PIECE WAS NOT FOUND IN EITHER THE SURGICAL FIELD OR SURGICAL SITE. NO PATIENT IMPACT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9765518 ↗
• InjuryJan 17, 2019Fracture; Fracture

  IT WAS REPORTED THAT ONE OF THE BITS TO THE MIDAS REX DRILL BROKE OFF AS IT WAS BEING USED. THE BROKEN TOOL WAS DISPOSED BY THE STAFF. NO PATIENT IMPACT REPORTED. ON FOLLOW-UP, IT WAS CONFIRMED WITH THE HOSPITAL THAT THERE WAS NO PATIENT OR STAFF IMPACT. IT WAS ALSO REPORTED THAT AN X-RAY PROCEDURE WAS DONE TO VERIFY IF THERE ARE ANY REMAINING PIECES OF BROKEN TOOL AND IT WAS CONFIRMED THAT THERE IS NONE LEFT IN THE PATIENT.

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

  MAUDE report 8256267 ↗

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)