Midas Rex® AS09SRecalls & reported problems
Medtronic Powered Surgical Solutions · ATT AS09S LEGEND 9CM STRAIGHT SH 3.2MM · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Midas Rex AS09S surgical drill attachment is a pneumatic motor attachment used in surgery. The 32 reports mostly describe parts coming loose or falling off, including detached bearings, and tools that would not lock in place or were hard to insert and remove. All reports note no patient harm, and there are no deaths or injuries. No recalls name this device, and reports rose from 5 to 26 in the past 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 31
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00613994418890), received between Aug 31, 2024 and Jun 26, 2026 — classified as 31 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (22 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component22
- Difficult to Insert10
- Corroded2
- Difficult to Remove1
Patient problems
- No Clinical Signs, Symptoms or Conditions31
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 26, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE ATTACHMENT WAS PARTS FALL OFF. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25632572 ↗MalfunctionJun 11, 2026Difficult to Insert
IT WAS REPORTED THAT POST OPERATION, THE UNABLE TO LOCK THE TOOL. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25473830 ↗MalfunctionJun 11, 2026Difficult to Insert
IT WAS REPORTED THAT AFTER OPERATION, TOOL COULD NOT BE LOCKED IN THE ATTACHMENT. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25466991 ↗MalfunctionJun 10, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING SURGERY, THE ATTACHMENT PARTS WERE FELL OFF. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25461728 ↗MalfunctionJun 8, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE DEVICE WITH PARTS FALL OFF. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25431564 ↗MalfunctionJun 7, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE DEVICE WITH PARTS FALL OFF. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25422028 ↗MalfunctionJun 5, 2026Difficult to Insert
IT WAS REPORTED THAT POST OPERATIVE, ATTACHMENT HAD DIFFICULTY TO INSERT TOOL. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25407491 ↗MalfunctionJun 5, 2026Corroded
IT WAS REPORTED THAT THE DURING PREOP BEARING WAS CORRODED. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25405523 ↗MalfunctionJun 5, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE DURING PREOP IN THE ATTACHMENT PARTS FELL OFF. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25405074 ↗MalfunctionJun 5, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE ATTACHMENT WITH THE REPORT OF BEARING DETACHED. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25403598 ↗MalfunctionJun 2, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE DEVICE OF PARTS FALL OFF. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25364282 ↗MalfunctionJun 1, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE PARTS WERE FELL OUT PRIOR TO THE PROCEDURE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25354019 ↗MalfunctionJun 1, 2026Difficult to Insert
IT WAS REPORTED THAT THE ATTACHMENT WITH THE REPORT OF TOOL CANNOT BE INSERTED. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMEN T. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25350820 ↗MalfunctionMay 29, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT PRIOR USE, ATTACHMENT PARTS FALL OFF. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25332643 ↗MalfunctionMay 29, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE DEVICE PARTS FALL OFF PRIOR TO USE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARING DETACHED WERE FOUND DURING EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25329570 ↗MalfunctionMay 29, 2026Difficult to Insert
IT WAS REPORTED THAT THE ATTACHMENT WITH THE REPORT OF TOOL CANNOT BE INSERTED. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25329561 ↗MalfunctionMay 29, 2026Corroded; Detachment of Device or Device Component
IT WAS REPORTED THAT THE DURING PREOP IN ATTACHMENT BEARING RUSTED AND FRACTURED. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25329543 ↗MalfunctionMay 29, 2026Difficult to Insert
IT WAS REPORTED THAT THE ATTACHMENT WITH THE REPORT OF TOOL CANNOT BE INSERTED. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25328201 ↗MalfunctionMay 29, 2026Difficult to Insert
IT WAS REPORTED THAT THE ATTACHMENT WITH THE REPORT OF TOOL CANT BE INSERTED. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25328105 ↗MalfunctionMay 29, 2026Difficult to Insert; Detachment of Device or Device Component
IT WAS REPORTED THAT THE ATTACHMENT WITH THE REPORT OF TOOL CANT BE INSERTED . IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25327776 ↗MalfunctionMay 29, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT PRIOR TO USE, ATTACHMENT PARTS FALL OUT. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25327280 ↗MalfunctionMay 27, 2026Difficult to Remove; Detachment of Device or Device Component
IT WAS REPORTED THAT DEVICE, PARTS FALL OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25297822 ↗MalfunctionMay 27, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DEVICE, PARTS FALL OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25297726 ↗MalfunctionApr 5, 2026Difficult to Insert
IT WAS REPORTED THAT DURING PRIOR TO USE THE ATTACHMENT WAS FOUND WITH DIFFICULT TO INSERT TOOL. THERE WAS NO PATIENT OR STAFF IMPACT. ADDITIONAL INFORMATION RECEIVED ON EVALUATION STATING THAT THE DISTAL BEARING WAS DETACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24786755 ↗MalfunctionNov 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE ATTACHMENT BEARING WAS DETACHED PRIOR TO USE. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23540461 ↗
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 · TerminatedMedtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.
- Z-0321-2016 · Oct 21, 2015 · TerminatedTool 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 · TerminatedMedtronic 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 · TerminatedMedtronic 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 · TerminatedMedtronic 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 · TerminatedMedtronic 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 · TerminatedMedtronic Midas Rex Legend High Speed Pneumatic System
- Z-0213-05 · Nov 3, 2004 · TerminatedMedtronic 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 · TerminatedLegend Lubricant System (Legend Gold, Gold Touch and Platinum motors and Legend Lubricant/Diffuser cartridge)
Other MOTOR, DRILL, PNEUMATIC devices
- NA 05.001.080Synthes GmbH · MOTOR, DRILL, PNEUMATIC432 reports
- NA CSR60Synthes GmbH · MOTOR, DRILL, PNEUMATIC221 reports
- Midas Rex® AF02Medtronic Powered Surgical Solutions · MOTOR, DRILL, PNEUMATIC163 reports
- Maestro Air 5407-200-000Stryker Corporation · MOTOR, DRILL, PNEUMATIC112 reports
- Maestro 5400210060Stryker Corporation · MOTOR, DRILL, PNEUMATIC95 reports
- MIDAS REX™ AF02Medtronic Powered Surgical Solutions · MOTOR, DRILL, PNEUMATIC91 reports
- CORE, Maestro 5400200000Stryker Corporation · MOTOR, DRILL, PNEUMATIC75 reports
- Maestro Air 5407-200-00HStryker Corporation · MOTOR, DRILL, PNEUMATIC56 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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