Midas Rex® TT12CRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994418739), received between Jul 12, 2018 and Oct 25, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 25, 2024Difficult to Insert; Detachment of Device or Device Component; Noise, Audible; Difficult to Insert; Detachment of Device or Device Component; Noise, Audible

  IT WAS REPORTED THAT A DEFECT WHEN INSERTING THE DRILL WHEN TESTED. THE DRILL DOES NOT REACH THE END OF THE TUBE AND WHEN SHAKING THE TUBE, A NOISE IS HEARD OF A LOOSE PART INSIDE IT. . THERE WAS NO PATIENT INVOLVED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20531492 ↗
• InjuryJul 12, 2018Detachment of Device or Device Component; Device Fell

  IT WAS REPORTED THAT THE TIP OF THE DEVICE CAME APART AND BALL BEARINGS FELL INTO THE WOUND. NO PATIENT IMPACT REPORTED. THERE WAS 20 MINS. DELAY. ON FOLLOW- UP IT WAS CONFIRMED THAT 4 OUT OF 6 BALL BEARINGS WERE REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUE. IT WAS ALSO NOTED THAT THE CURRENT STATUS OF THE PATIENT POST-SURGERY IS DOING WELL.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 7684405 ↗

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)