Navio PFSR120031Recalls & reported problems
Smith & Nephew, Inc. · Navio BBT Footpedal · 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 00885556628485), received between Apr 23, 2020 and Dec 14, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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.
Reports received per month
Most reported problems
Device problems
- Loose or Intermittent Connection1
- Self-Activation or Keying1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 14, 2023Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT, DURING A CORI ASSISTED UKA SURGERY, WHILE BURRING THE FEMUR, THE DRILL WOULD INTERMITTENTLY STOP. THE TEAM TRIED USING A NEW ANSPACH DRILL BUT THE SAME THING HAPPENED. THEY ALSO TRIED USING A DIFFERENT NAVIO HANDPIECE BUT THE SAME ISSUE CONTINUED TO OCCUR. THE SURGERY WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, SWITCHING TO MANUAL INSTRUMENTATION. AFTER THE CASE THEY NOTICED THAT THE OR BED WAS LOCKED ON TOP OF THE NAVIO BBT FOOTPEDAL CORD. NO INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18326689 ↗InjuryApr 23, 2020Self-Activation or Keying; Self-Activation or Keying
IT WAS REPORTED THAT BLUE BELT FOOT PEDAL REMAINS PERMANENTLY IN THE ACTIVE POSITION. SURGERY WAS COMPLETED WITH LEGION STANDARD INSTRUMENTATION. IT IS UNKNOWN IF THERE WAS A DELAY BUT NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9990045 ↗
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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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