Navio PFSR110005Recalls & reported problems
Smith & Nephew, Inc. · Navio Point Probe · Class 2
All models of Navio (23)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556628522), received between Apr 23, 2020 and Apr 25, 2020 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (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.
Most reported problems
Device problems
- Difficult to Remove1
- Mechanical Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 25, 2020Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT PLATE PROBES NEED TO BE REPLACED DUE TO FIT ISSUES. NO PATIENT INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 9999141 ↗InjuryApr 23, 2020Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT POINTER COULD ONLY HARDLY BE SEPARATED FROM THE HANDPIECE AFTER REGISTRATION. SURGERY WAS COMPLETED WITH LEGION STANDARD INSTRUMENTATION. IT IS UNKNOWN IF THERE WAS A DELAY OR IF THERE WAS PATIENT IMPACT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9991191 ↗
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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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