N/A 960-524 (UDI 00763000055356)Recalls & reported problems
Medtronic Navigation, Inc. · INST 960-524 BIT 3MM-UC DRILL GUIDE · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000055356), received between Feb 3, 2023 and Feb 3, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Integrity Problem” (1 report).
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 Problem1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 3, 2023Use of Device Problem; Material Integrity Problem; Use of Device Problem; Material Integrity Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A PELVIC TRAUMA SURGERY. IT WAS REPORTED THAT THE SURGEON HAD TO USE MORE FORCE AND WEIRD ANGLED TRAJECTORIES CAUSING THE DRILL BIT TO BEND SLIGHTLY AND CAUSED A 3.0 AND 2.1 DRILL BIT TO BREAK. ONE BROKE FROM PULLING AND ONE BROKE FROM PUSHING. THIS CAUSED LESS THAN ONE HOUR OF DELAY AND HAD NO IMPACT ON PATIENT OUTCOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16296591 ↗
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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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