NA 9735124Recalls & reported problems
Medtronic Navigation, Inc. · INST KIT 9735124 HANDLE RACHETING · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000207632), received between Apr 13, 2021 and Jul 24, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (3 reports).
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
Device problems
- Material Integrity Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 24, 2023Material Integrity Problem; Material Integrity Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE ISSUE WAS RELATED TO A SURGICAL INSTRUMENT, SPECIFICALLY A SCREW DRIVER HANDLE THAT WAS A UNIVERSAL USED HANDLE. THE HEALTH CARE PROFESSIONAL WAS USING A MALLET ON THE END OF THE HANDLE (AS IS STANDARD TECHNIQUE) AND THE RATCHETING RING ON HANDLE FELL APART. THEY SWITCHED HANDLES OUT WITH ANOTHER HANDLE. THERE WAS NO DELAY OR IMPACT TO PATIENT CARE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17378586 ↗MalfunctionJun 23, 2022Material Integrity Problem; Material Integrity Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE RATCHETING HANDLE INSTRUMENT APPEARED BROKEN. THERE WAS NO PATIENT PRESENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14787830 ↗MalfunctionApr 13, 2021Material Integrity Problem; Material Integrity Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE HANDLE WAS BROKEN DUE TO MALLETING. THERE WAS NO REPORTED DELAY TO THE PROCEDURE. NO IMPACT ON PATIENT OUTCOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11655929 ↗
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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