N/A 9734435 (UDI 00763000234218)Recalls & reported problems
Medtronic Navigation, Inc. · TACTILE 9734435 AWL · 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 00763000234218), received between Aug 5, 2025 and Aug 5, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanical 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.
Reports received per month
Most reported problems
Device problems
- Mechanical 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.
MalfunctionAug 5, 2025Mechanical Problem; Mechanical Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE TACTILE AWL INSTRUMENT WAS DEFORMED, THIS WAS CONFIRMED DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. THE TIP OF THE INSTRUMENT WAS DEFORMED. IT WAS CONFIRMED HOW THE INSTRUMENT GOT DAMAGED FROM WHEN THE USER WAS DRILLING, FORCE WAS APPLIED AND THE TIP WAS BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22720584 ↗
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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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