Navio PFSDV0016Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 20885556628908), received between Jul 3, 2020 and May 9, 2025 — classified as 6 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (8 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, 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

Recent adverse event reports

The 25 most recent of 29 reports, 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 ↗
• 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 ↗
• InjuryMay 9, 2022Material Twisted/Bent; Intermittent Communication Failure; Material Twisted/Bent; Intermittent Communication Failure

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, THE REAL INTELLIGENCE FEMUR TRACKER WAS BLINKING IN AND OUT OF CAMERA VIEW DESPITE THE CAMERA WAS LOOKING DIRECTLY AT IT. ALSO, AN EXCESSIVE AMOUNT OF WRITING WAS NOTICED ON THE REFLECTIVE SURFACE OF THE FLAT MARKER; THEREFORE, THEY SWAPPED THE NOTED FLAT MARKER OUT, BUT IT DID NOT HELP. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, BY CHANGING TO MANUAL PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. MOREOVER, THE REAL INTELLIGENCE FEMUR TRACKER APPEARS TO BE BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14342729 ↗
• InjuryAug 13, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING CALIBRATION, BEFORE A CORI ASSISTED TKA, HOMING WAS COMPLETED AT FIRST ATTEMPT. POINT PROBE VERIFICATION FAILED WITH ERROR: THE POINT PROBE TIP DID NOT REGISTER NEAR ANY OF THE DIVOTS. PLEASE ENSURE THE FOLLOWING: *THE PROBE TIP IS IN THE TRACKER DIVOT, AND *THE TRACKER AND PROBE ARE VISIBLE TO THE CAMERA. BOTH POINT PROBE AND TRACKER WERE SOLID GREEN ON SCREEN. DIFFERENT ANGLES AND DISTANCES WERE TRIED FROM CAMERA AND STILL SAME ERROR. THEY DISASSEMBLED DRILL COMPLETELY THEN REASSEMBLED. HOMING CALIBRATION WAS COMPLETED AT FIRST TRY, BUT THE POINT PROBE VERIFICATION FAILED AGAIN. AGAIN, THEY TRIED IT A FEW MORE TIMES AND ALL FAILED. THEY CHECKED FLAT MARKER ATTACHMENT MULTIPLE TIMES, REPLACED TWO THAT MAY HAVE LOOKED DIRTY BUT STILL DID NOT VERIFY. BY THAT MOMENT, TOO MUCH TIME WENT BY. SURGEON WAS READY TO BEGIN AND DECIDED TO DO MANUAL INSTRUMENTATION. THEREFORE, THE PROCEDURE WAS COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES, BY CHANGING THE SURGICAL TECHNIQUE. THEY TOOK THE HARDWARE AND UNIT OUTSIDE TO SEE WHAT COULD HAVE BEEN THE CAUSE. AFTER EXTREME FORCE, THEY WERE ABLE TO GET A MARKER ON PROBE TO SNAP IN. THIS ACCOUNT HAS COMPLAINED EVER SINCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12321215 ↗
• InjuryJan 10, 2021Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT, DURING A CORI TKA PROCEDURE, THE CASE COULD NOT MOVE FORWARD PAST THE CALIBRATION. IT WAS VERIFIED THAT EVERYTHING WAS ASSEMBLED CORRECTLY, BUT EVEN THEN THE ROBOTIC DRILL WOULD NOT CALIBRATE DUE TO A DEFECTIVE FLAT MAKER THAT SEEMED TO NOT BE SITTING PROPERLY. UNFORTUNATELY, THIS WAS THE LAST TRAY THEY HAD AVAILABLE FOR THE DAY, SO THE CASE WAS COMPLETED WITH STANDARD MANUAL INSTRUMENTATION WITH A DELAY OF FEWER THAN 30 MINUTES. AFTER THE ROBOTIC DRILL WAS TAKEN OFF THE FIELD, THEY RESTARTED THE MACHINE AND TRIED TO MOVE THROUGH THE CALIBRATION PHASE. THAT WAS WHEN IT WAS NOTICED ONE OF THE FLAT MARKERS NOT BE SITTING PROPERLY. IT WAS TRIED TO SNAP IT ON FURTHER, BUT IT WAS AS FAR IN AS POSSIBLE. THAT ONEW WAS SWAPPED OUT AND THEN WERE ABLE TO MOVE PAST CALIBRATION. IT SEEMS THAT THE FLAT MARKER WAS DEFECTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11144525 ↗
• MalfunctionSep 1, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A NAVIO TKA PROCEDURE, WHEN TRYING TO BUR THE DISTAL FEMUR, THE BUR WOULD NOT EXTEND PAST THE GUARD. THERE WAS OVER 2 MM OF BONE SHOWING ON THE MODEL. THEY TRIED CHECKING TO MAKE SURE THE BUR HAD NOT BACKED OUT, UNPLUGGED AND PLUGGED THE BUR BACK IN, CHECKED THE CHECKPOINTS, RE -CALIBRATED, AND CHANGED THE HANDPIECES. THE SAME ISSUE CONTINUED TO PERSIST. FINALLY, IT WORKED AFTER GOING BACK INTO THE PLANNING SCREEN AND ADJUSTING THE DISTAL TO BE 0.5 MM MORE AND THEN MOVED IT BACK TO THE ORIGINAL SPOT. WHEN THEY GOT BACK TO THE CUTTING SCREEN THE BUR WORKED. THERE WAS A DELAY GREATER THAN 30 MINUTES DUE TO THIS ISSUE. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10480786 ↗
• MalfunctionAug 21, 2020Intermittent Communication Failure; Intermittent Communication Failure

  IT WAS REPORTED THAT DURING A CORI TKA PROCEDURE, THE CAMERA DISCONNECTED JUST AFTER VERIFYING CHECKPOINTS TO ADVANCE TO BONE PREP ON THE FEMUR. THEY RECOVERED BY RE-BOOTING THE SYSTEM AND RE-CALIBRATING. THE PROCEDURE WAS COMPLETED AS PLANNED. THERE WAS A DELAY OF LESS THAN 30 MINUTES AND THERE WAS NO IMPACT/HARM TO THE PATIENT. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10437953 ↗
• MalfunctionAug 21, 2020Intermittent Communication Failure; Intermittent Communication Failure

  IT WAS REPORTED THAT DURING A CORI TKA PROCEDURE, THEY RECEIVED A CAMERA DISCONNECTION ERROR JUST AFTER THE ARRAYS WERE PUT IN AND WERE ABOUT TO BEGIN REGISTRATION. THEY RECOVERED BY HITTING THE CONTINUE BUTTON. THE CAMERA RE-INITIALIZED AND THERE WAS NO NEED TO RE-BOOT AND RE-CALIBRATE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AS PLANNED WITH CORI. THERE WAS A DELAY OF LESS THAN 30 MINUTES AND NO IMPACT TO THE PATIENT. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10437945 ↗
• MalfunctionAug 21, 2020Application Program Problem: Parameter Calculation Error; Application Program Problem: Parameter Calculation Error

  IT WAS REPORTED THAT DURING A NAVIO TKA PROCEDURE, IN THE CUT TIBIA OPTION THERE WAS AN ERROR MESSAGE THAT PROMPTED US THAT A BONE MODEL WAS NOT SUFFICIENTLY GENERATED. THEY WENT BACK AND COLLECTED A COUPLE MORE DATA POINTS IN ORDER TO BYPASS THIS ERROR. THERE WERE NO DELAYS IN THE PROCEDURE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10437834 ↗
• InjuryAug 21, 2020Computer Operating System Problem; Application Program Freezes or Fails to Launch; Computer Operating System Problem; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT, DURING A NAVIO-ASSISTED PROCEDURE, THE SCREEN FROZE. THEY WERE UNABLE TO HIT ANY BUTTONS ON TOUCHSCREEN. ALTHOUGH THE UNIT WAS REBOOTED, SURGERY WAS CHANGED TO MANUAL INSTRUMENTS. SURGERY WAS NOT DELAYED BEYOND 30 MIN. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10437739 ↗
• MalfunctionAug 20, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A NAVIO UKR PROCEDURE, AFTER IMPLANT PLANNING WHEN THE SURGEON WANTED TO BURR THE FEMUR, THE MESSAGE HANDPIECE EXPOSURE CONTROL MOTOR FAILURE APPEARED. THEY OPENED ANOTHER NAVIO SET INSTRUMENT TO SWAP THE HANDPIECE TO CONTINUE THE PROCEDURE WITHOUT ISSUES. THERE WAS A DELAY OF 10 MINUTES. AFTER THE SURGERY, BOTH HANDPIECE AND ANSPACH WERE TESTED AND WERE FINE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10432027 ↗
• InjuryAug 20, 2020Application Program Problem; Application Program Problem

  IT WAS REPORTED THAT DURING A NAVIO UKR PROCEDURE, THE SURGEON USED MANUAL CUTTING BLOCKS FOR BOTH THE TIBIA AND THE FEMUR AND FINISHED OFF WITH THE NAVIO BUR. THE FEMUR LUG HOLES PLANNED WITH NAVIO DID NOT MATCH THE FINAL LUG HOLES CHOSEN BY THE SURGEON. THEY REVERTED TO MANUAL INSTRUMENTS. THIS CAUSED A DELAY OF LESS THAN 30 MINUTES.

  Patient problems: Failure of Implant; Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10431343 ↗
• MalfunctionJul 10, 2020Crack; Crack

  IT WAS REPORTED THAT DURING SURGERY, IT WAS FOUND THAT THE TIP OF THE NAVIO BONE PIN 4.0 MM X 127 MM PIN WAS CRACKED. THE BACKUP WAS USED TO CONTINUE THE PROCEDURE WITHOUT DELAYS. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10260426 ↗
• MalfunctionJul 10, 2020Solder Joint Fracture; Solder Joint Fracture

  IT WAS REPORTED THAT DURING A TKA PROCEDURE, THE ADAPTER CAN NO LONGER FIX THE NAVIO BONE SCREW DRIVERS. THEY WERE WORN OUT. THEY WERE SWAPPED FOR THEIR BACKUPS TO CONTINUE THE PROCEDURE WITH A DELAY OF LESS THAN 30 MINUTES. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10257715 ↗
• MalfunctionJul 3, 2020Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT A BOX OF FLAT MARKERS HAD BEEN USED BEYOND ITS EXPIRATION DATE. THE CUSTOMER KEPT THEM ON THEIR SHELF AND OBTAINED RESTOCK FROM THE OFFICE. IT WAS NOTICED DURING THE SETUP OF AN UKR PROCEDURE, THAT THE DEVICES HAD EXPIRED IN FEBRUARY 2020. THIS IS THE EIGHTH OF EIGHT BOXES USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10228576 ↗
• MalfunctionJul 3, 2020Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT A BOX OF FLAT MARKERS HAD BEEN USED BEYOND ITS EXPIRATION DATE. THE CUSTOMER KEPT THEM ON THEIR SHELF AND OBTAINED RESTOCK FROM THE OFFICE. IT WAS NOTICED DURING THE SETUP OF AN UKR PROCEDURE, THAT THE DEVICES HAD EXPIRED IN FEBRUARY 2020. THIS IS THE THIRD OF EIGHT BOXES USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10228557 ↗
• MalfunctionJul 3, 2020Off-Label Use; No Apparent Adverse Event; Off-Label Use; No Apparent Adverse Event

  IT WAS REPORTED THAT A BOX OF FLAT MARKERS HAD BEEN USED BEYOND ITS EXPIRATION DATE. THE CUSTOMER KEPT THEM ON THEIR SHELF AND OBTAINED RESTOCK FROM THE OFFICE. IT WAS NOTICED DURING THE SETUP OF AN UKR PROCEDURE, THAT THE DEVICES HAD EXPIRED IN FEBRUARY 2020. THIS IS THE SIXTH OF EIGHT BOXES USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10228552 ↗
• MalfunctionJul 3, 2020Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT A BOX OF FLAT MARKERS HAD BEEN USED BEYOND ITS EXPIRATION DATE. THE CUSTOMER KEPT THEM ON THEIR SHELF AND OBTAINED RESTOCK FROM THE OFFICE. IT WAS NOTICED DURING THE SETUP OF AN UKR PROCEDURE, THAT THE DEVICES HAD EXPIRED IN FEBRUARY 2020. THIS IS THE FIFTH OF EIGHT BOXES USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10228543 ↗