N/A 960-527 (UDI 00763000055363)Recalls & reported problems
Medtronic Navigation, Inc. · INST 960-527 CANCELLOUS BIT 3MM UC DRIL · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000055363), received between Feb 3, 2023 and Feb 13, 2025 — classified as 2 malfunctions.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Integrity Problem1
- Mechanical Problem1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 13, 2025Mechanical Problem; Mechanical Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CERVICAL SPINE PROCEDURE. IT WAS REPORTED THAT THE SITE WAS PREPARING TO UTILIZE A DRILL BIT WITH THE UNIVERSAL DRILL GUIDE (UDG), WHEN IT WAS FOUND THAT THE TIP WAS BENT. THE SITE ATTEMPTED TO OPEN AN ALTERNATE KIT, HOWEVER, BOTH KITS HAD BENT TIPS. WHEN THE DRILL BIT WAS LOADED INTO THE UDG, THEY WENT TO SPIN IT AND IT WOBBLED. THE DRILL BIT COULD BE ROLLED ACROSS A TABLE, AND THERE WAS A BEND IN THE TIP THAT WENT INTO THE ACTUAL DRILL. WHAT THEY DETERMINED HAPPENED MOST LIKELY WAS POOR HANDLING IN THE STERILE PROCESSING DEPARTMENT (SPD) THAT CAUSED THE BENT TIPS. THE SURGERY WAS ABORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21374185 ↗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 16296600 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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