Navio PFSR101067Recalls & reported problems
Smith & Nephew, Inc. · Navio 5mm Exposure Control Guard · 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 00885556628690), received between Nov 29, 2022 and Nov 29, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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 Fragmentation1
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.
MalfunctionNov 29, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT, DURING A NAVIO ASSISTED TKA SURGERY, THEY NOTED A LOUDER NOISE THAN NORMAL WITH THE NAVIO HANDPIECE AND DRILL. UPON INSPECTION, THEY NOTED SMALL AMOUNT OF METAL SHAVING. THE FIRST IRRIGATED/SUCTIONED THE FIELD TO REMOVE THE METAL SHAVING. PER VISUAL INSPECTION, ALL MATERIAL WAS PROPERLY CLEANED AND NO HARM DONE TO THE PATIENT. THEN, THEY REMOVED THE 5MM GUARD AND ASSEMBLED THE SPEED GUARD, SWITCHED THE ROBOTIC CONTROLS FROM EXPOSURE TO SPEED AND PREPPED THE REMAINDER OF THE DISTAL FEMUR WITHOUT ERROR. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT SIGNIFICANT DELAYS. FOLLOWING THE CASE, THE SPD STAFF NOTED SMALL FRAGMENTS OF METAL INSIDE THE BARREL OF THE 5MM EXPOSURE GUARD. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15875771 ↗
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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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