N/A 960-523Recalls & reported problems
Medtronic Navigation, Inc. · BIT GUIDE 960-523, 3MM-UC DRILL GUIDE · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000055349), received between May 2, 2018 and Mar 10, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (2 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.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation2
- Mechanical Jam1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Patient Involvement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 10, 2026Mechanical Jam
IT WAS REPORTED THAT THE GUIDE PIN WAS ACTIVELY BEING USED/IN ROTATION WHILE IT GOT STUCK. THE ISSUE WAS RESOLVED BY HAVING ANOTHER GUIDE PIN BROUGHT OUT TO COMPLETE THE PROCEDURE UNDER FLUOROSCOPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24560276 ↗MalfunctionOct 31, 2025Material Fragmentation; Material Fragmentation
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE WELDED KNOB CAME OFF THE INNER TROCAR OF THE UNIVERSAL DRILL GUIDE (UDG) PRE-CASE DURING SETUP, BEFORE INCISION AND AFTER ANESTHESIA HAD BEEN ADMINISTERED. NO ISSUES WERE NOTED BY CENTRAL STERILE SERVICES DEPARTMENT (CSSD) DURING CLEANING/STERILIZATION. A DIFFERENT TROCAR WAS USED AND THE SURGERY PROCEEDED AS USUAL WITHOUT DELAY OR DISCONTINUATION OF NAVIGATION. THERE WAS NO DELAY, AND NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438876 ↗MalfunctionAug 15, 2024Material Fragmentation; Material Fragmentation
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE DRILL BIT FROM THE DRILL GUIDE BROKE. THEY WIPED THE DRILL BIT AT THE FRONT END AND THEN HAD TWO PARTS IN THEIR HAND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19990940 ↗MalfunctionMay 2, 2018Mechanical Problem; Mechanical Problem
MEDTRONIC RECEIVED INFORMATION THAT A SITE NURSE DISCOVERED A DAMAGED DRILL BIT WHILE WASHING AFTER A PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 7481730 ↗
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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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