NAVIO PFSR015001Recalls & reported problems
Smith & Nephew, Inc. · NAVIO TISSUE PROTECTOR · Class 2
All models of Navio (23)
Data updated Oct 18, 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 00885556649558), received between Jun 22, 2021 and Jun 22, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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
- Material Split, Cut or Torn1
- Physical Resistance/Sticking1
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.
MalfunctionJun 22, 2021Material Split, Cut or Torn; Physical Resistance/Sticking; Material Split, Cut or Torn; Physical Resistance/Sticking
IT WAS REPORTED THAT DURING A NAVIO ASSISTED TKA SURGERY THE ANSPACH EMAX 2 PLUS HAND PIECE - ROHS SEPARATED FROM THE BURR TWICE CASE (B)(4) AND THE NAVIO TISSUE PROTECTOR WAS GETTING BOUND UP WITH A PIN AND HAS DAMAGED THE INTERNAL CANNULA CASE(B)(4). THE PROCEDURE WAS COMPLETED, WITH A DELAY OF FEWER THAN 30 MINUTES. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12044154 ↗
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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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