NavioRecalls & reported problems across all models

We found 23 models of Navio by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 928 adverse event reports in the FDA's MAUDE database, received between Jul 24, 2019 and May 9, 2025 — classified as 282 injuries, 646 malfunctions.

The most frequently reported specific device problem is “Break” (161 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Navio problems

Navio models

23 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Navio PFSR110137

  Orthopedic stereotaxic instrument
  286 reports
• Navio NPFS02000

  Orthopedic stereotaxic instrument
  202 reports
• Navio PFSR110164

  Orthopedic stereotaxic instrument
  147 reports
• Navio PFSR110006

  Orthopedic stereotaxic instrument
  66 reports
• Navio PFSD01008

  Orthopedic stereotaxic instrument
  57 reports
• NAVIO PFSR100026

  Orthopedic stereotaxic instrument
  48 reports
• Navio PFSDV0016

  Orthopedic stereotaxic instrument
  29 reports
• NAVIO ROB00004

  Orthopedic stereotaxic instrument
  19 reports
• Navio PFSR101092

  Orthopedic stereotaxic instrument
  16 reports
• NAVIO ROB00031

  Orthopedic stereotaxic instrument
  16 reports
• Navio PFSR110008

  Orthopedic stereotaxic instrument
  14 reports
• Navio PFSR120010

  Orthopedic stereotaxic instrument
  9 reports
• Navio PFSD01009

  Orthopedic stereotaxic instrument
  5 reports
• Navio PFSR110001

  Orthopedic stereotaxic instrument
  2 reports
• Navio PFSR120031

  Orthopedic stereotaxic instrument
  2 reports
• Navio PFSR110005

  Orthopedic stereotaxic instrument
  2 reports
• Navio PFSR110018

  Orthopedic stereotaxic instrument
  2 reports
• Navio PFSR101067

  Orthopedic stereotaxic instrument
  1 report
• NAVIO PFSR015001

  Orthopedic stereotaxic instrument
  1 report
• NAVIO ROB00025

  Orthopedic stereotaxic instrument
  1 report
• NAVIO ROB00026

  Orthopedic stereotaxic instrument
  1 report
• NAVIO ROB00006

  Orthopedic stereotaxic instrument
  1 report
• NAVIO ROB00061

  Orthopedic stereotaxic instrument
  1 report

Recent Navio adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2025Optical Problem; Optical Problem

  IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI ASSISTED TKA SURGERY, ONE (1) REAL INTELLIGENCE FLAT MARKERS WERE FLICKERING THROUGHOUT CASE. THEY WERE ABLE TO PROCEED, BUT THERE WAS CONSTANT FLICKERING. ALL TROUBLESHOOTING WAS DONE; NOTHING FIXED IT COMPLETELY. THE PROCEDURE WAS RESUMED AFTER A SIGNIFICANT DELAY USING THE SAME DEVICE, AND NO INJURIES WERE REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21996012 ↗
• MalfunctionMar 7, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING A NAVIO ASSISTED SURGERY, AN UNSPECIFIED FAILURE OF THE HANDPIECE OCCURRED. IT WAS NOT POSSIBLE TO GATHER GAP DATA. THE PROCEDURE WAS PERFORMED BY CHANGED TO MANUAL INSTRUMENTATION. IT IS UNKNOWN IF THERE WAS ANY DELAY. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN. THIS INFORMATION WAS COLLECTED RETROSPECTIVELY AS PART OF A POST-MARKET CLINICAL FOLLOW UP ACTIVITY AND IS PROVIDED IN AN ANONYMIZED FORMAT; THEREFORE, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21547993 ↗
• MalfunctionMar 7, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING SET-UP FOR A NAVIO ASSISTED SURGERY, AN UNSPECIFIED ROBOTIC FAILURE OCCURRED. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, BY CHANGE TO MANUAL INSTRUMENTATION. SINCE THE INCIDENT OCCURRED BEFORE THE PROCEDURE, THE PATIENT WAS NOT YET INVOLVED. THIS INFORMATION WAS COLLECTED RETROSPECTIVELY AS PART OF A POST-MARKET CLINICAL FOLLOW UP ACTIVITY AND IS PROVIDED IN AN ANONYMIZED FORMAT; THEREFORE, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21547841 ↗
• MalfunctionMar 7, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING SET-UP FOR A NAVIO ASSISTED SURGERY, AN UNSPECIFIED ROBOTIC FAILURE OCCURRED. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, BY CHANGED TO MANUAL INSTRUMENTATION. SINCE THE INCIDENT OCCURRED BEFORE THE PROCEDURE, THE PATIENT WAS NOT YET INVOLVED. THIS INFORMATION WAS COLLECTED RETROSPECTIVELY AS PART OF A POST-MARKET CLINICAL FOLLOW UP ACTIVITY AND IS PROVIDED IN AN ANONYMIZED FORMAT; THEREFORE, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21547804 ↗
• MalfunctionMar 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING A NAVIO ASSISTED LEFT TKA SURGERY ON (B)(6) 2019, AN UNSPECIFIED TECHNICAL ERROR OCCURRED. THE SURGERY WAS COMPLETED BY CHANGING TO MANUAL PROCEDURE. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN. THIS INFORMATION WAS COLLECTED RETROSPECTIVELY AS PART OF A POST-MARKET CLINICAL FOLLOW UP ACTIVITY AND IS PROVIDED IN AN ANONYMIZED FORMAT; THEREFORE, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 21537837 ↗
• MalfunctionMay 23, 2024Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT DURING A CORI ASSISTED TKA SURGERY, THE SCREEN SHOWED THE POINTER SENSOR AND TIBIA IN GREEN, BUT IT DID NOT RECOGNIZE TWO (2) NAVIO FLAT MARKERS WHEN POSITIONING THE POINTER ON THE THUMBTACK. DUE TO THIS, THE PROCEDURE GOT CANCELLED. NO FURTHER CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19383260 ↗
• MalfunctionApr 10, 2024Nonstandard Device; Structural Problem; Nonstandard Device; Structural Problem

  IT WAS REPORTED THAT DURING A CORI ASSISTED TKA SURGERY, THE CAMERA COULD NOT DETECT THE NAVIO FLAT MARKER. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, USING MANUAL TECHNIQUE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19080559 ↗
• MalfunctionApr 2, 2024Nonstandard Device; Optical Problem; Nonstandard Device; Optical Problem

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA PROCEDURE, THERE WERE SOME ISSUES WITH VISUALIZATION. THE NAVIO FLAT MARKERS WERE CLEANED OFF, BUT DURING BURRING THEY WERE FLICKERING VERY CONSISTENTLY. THE PROCEDURE WAS COMPLETED, AFTER A SIGNIFICANT DELAY. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19021492 ↗
• MalfunctionApr 2, 2024Nonstandard Device; Optical Problem; Nonstandard Device; Optical Problem

  IT WAS REPORTED THAT DURING CORI ASSISTED TKA SURGERY, THE SURGEON WAS PERFORMING THE CAMERA ORIENTATION AND ADJUSTMENT AND THE NAVIO FLAT MARKERS WERE FLICKERING ON THE SCREEN. THE CAMERA WAS MOVED SEVERAL TIMES TO ATTEMPT TO OVERCOME THE ISSUE, UNFORTUNATELY THIS FAILED. SURGERY WAS RESUMED BY MANUAL PROCEDURE AFTER A NON-SIGNIFICANT DELAY. NO INJURIES TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19021277 ↗
• InjuryMar 19, 2024Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT DURING A CORI ASSISTED TKA SURGERY, THE HANDPIECE TRACKER BEGAN TO FLICKER WHEN THE BUR WAS STARTED. THE FLICKERING BECAME EXTREME VERY QUICKLY AND CAUSED THE BUR TO TAKE TOO MUCH BONE ON THE DISTAL FEMUR. THE CAMERA WAS POINTED DIRECTLY AT THE FLAT MARKERS AND THERE WAS NO BLOOD ON THEM. WHEN HELD AT VARIOUS ANGLES, THEY WOULD BE SEEN PERFECTLY. THE SILVER WAS NOT DULL AND THEY DID NOT LOOK VISUALLY DAMAGED. WHEN ALL THE FLATMARKERS WERE CHANGED, THE TRACKER WAS SEEN. THERE WAS NO ISSUE WITH THE TRACKER ITSELF. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: Laceration(s)

  MAUDE report 18937009 ↗
• MalfunctionMar 4, 2024Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA PROCEDURE, THE NAVIO FLAT MARKERS WERE NOT ABLE TO BE SEEN, THEY WERE SWITCHED OUT FOR NEW ONES, AS THE ENTIRE ARRAY WAS NOT SHOWING UP ON THE SCREEN. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18833431 ↗
• MalfunctionMar 4, 2024Nonstandard Device; Optical Problem; Nonstandard Device; Optical Problem

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA PROCEDURE, THE NAVIO FLAT MARKERS WERE NOT BEING SEEN BY THE CAMERA. THEY FLICKERED AND WON'T FULLY BE SEEN. EVEN AFTER REPLACING SOME OF THEM, THEY WERE STILL NOT ABLE TO BE FULLY SEEN. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18833164 ↗
• MalfunctionFeb 21, 2024Nonstandard Device; Optical Problem; Nonstandard Device; Optical Problem

  IT WAS REPORTED THAT DURING A CORI ASSISTED TKA SURGERY, THE NAVIO FLAT MARKERS WERE FLICKERING AND THEY WERE UNABLE TO BE SEEN AT TIMES .THE PROCEDURE WAS PERFORMED, AFTER A SIGNIFICANT DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18751768 ↗
• 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 ↗
• InjuryNov 29, 2023Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT DURING SET-UP FOR A NAVIO-ASSISTED PROCEDURE, THE NAVIO SURGICAL SYSTEM US FAILED TO TURN ON. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, CHANGING TO MANUAL PROCEDURE. AS THIS HAPPENED BEFORE SURGERY, PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18234378 ↗

Other Smith & Nephew, Inc. products

• FAST-FIX18 models · 9,554 reports
• JOURNEY566 models · 6,250 reports · 4 recalls
• GENESIS II462 models · 4,599 reports · 2 recalls
• DYONICS, POWERMAX, ELITE2 models · 4,308 reports
• TRIGEN381 models · 3,599 reports · 5 recalls
• LEGION446 models · 2,039 reports · 4 recalls
• REAL INTELLIGENCE32 models · 2,017 reports · 3 recalls
• Coblation62 models · 2,126 reports