NAVIO ROB00026Recalls & reported problems
Smith & Nephew, Inc. · NAVIO Total Knee Arthroplasty RIGHT TIBIA TWIN PEG CUT GUIDE · 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 00885556684979), received between Oct 22, 2020 and Oct 22, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (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
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 22, 2020Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT, DURING A CORI TKA PROCEDURE, THE BONE PIN GOT STUCK IN THE TWIN PEG GUIDE. IT WAS STILL USED, THE OTHER PIN HOLES WERE USED TO SECURE THE DEVICE TO CUT THE TIBIA WITHOUT DELAYS. LATER, THE SPD TRIED TO GET IT OUT AND WEREN'T ABLE TO. NO OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10718439 ↗
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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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