Navio PFSR110137Recalls & reported problems

Summary

The FDA's MAUDE database contains 286 adverse event reports that list this exact device (DI 00885556628515), received between Jul 24, 2019 and Mar 7, 2025 — classified as 69 injuries, 217 malfunctions.

The most frequently reported specific device problem is “Break” (73 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 286 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryNov 12, 2022Retraction Problem; Noise, Audible; Retraction Problem; Noise, Audible

  IT WAS REPORTED THAT, DURING A NAVIO-ASSISTED TKA SURGERY, WHEN THE NAVIO HANDPIECE WAS IN CALIBRATION PROCEDURE, A HOMING ERROR WAS RECEIVED. THERE IS AN ABNORMAL SOUND WHEN HANDPIECE MOTOR IS RUNNING AND THE TEST SHOWED T1 MAX TORQUE 56. SURGERY WAS FINISHED MANUALLY AFTER A NON-SIGNIFICANT DELAY. NO HARM TO THE PATIENT NOR FURTHER COMPLICATIONS REPORTED. 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 15785919 ↗
• MalfunctionNov 10, 2022Circuit Failure; Circuit Failure

  IT WAS REPORTED THAT, DURING A NAVIO-ASSISTED TOTAL KNEE ARTHROPLASTY, ERROR CODE 40000000000 AND 41800000000 APPEARED ON THE SCREEN WHILE USING TWO (2) NAVIO HANDPIECES. REGISTRATION TESTS FAILED DESPITE USING A NEW NAVIO; HOWEVER, THE FIRST HANDPIECE (SN = (B)(4)) HAD NOT BEEN ISOLATED FROM FIRST UNIT FAILURE. THE SECOND UNIT SUSPECTED SIU FAILURE FROM HANDPIECE. MULTIPLE ATTEMPTS WERE CARRIED TO REBOOT AND RESTART. THE HANDPIECE WAS CHANGED, BUT BY THEN FAULT WAS ALREADY CONSISTENTLY REGISTERING. DUE TO THIS PROBLEM, THE PATIENT HAD TO BE WOKEN UP AND THE CASE POSTPONED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15770543 ↗
• MalfunctionSep 28, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A NAVIO ASSISTED TKA SURGERY, IT WAS FOUND THAT THE NAVIO HANDPIECE THUMBERSCREW IS FRACTURED. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15498443 ↗
• InjuryAug 17, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT, ON THE LITERATURE REVIEW "IS ROBOTIC-ASSISTED UNICOMPARTMENTAL KNEE ARTHROPLASTY A SAFE PROCEDURE? A CASE CONTROL STUDY", FOUR (4) UKA PROCEDURES ASSISTED WITH A BLUE BELT NAVIO ROBOTIC SURGICAL SYSTEM WERE ABORTED AND COMPLETED WITH CONVENTIONAL INSTRUMENTATION. ONE (1) OF THESE CASES WAS ABORTED DUE TO THE BURR ROTATING TOO FAST, LEADING TO AN OVERHEATING OF THE ROBOTIC HANDPIECE AND MAKING NECESSARY TO STOP THIS SYSTEM BEFORE BONE RESECTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15246071 ↗
• InjuryJul 21, 2022Circuit Failure; Circuit Failure

  IT WAS REPORTED THAT DURING SET UP FOR A NAVIO TKA SURGERY, THE UNIT DISPLAYED ERROR MESSAGES FOR FOOT PEDALS AND HANDPIECE. THEY DID USUAL CASCADE OF REBOOTS, RESETS, PLUG/UNPLUG. ULTIMATELY THE 4000000000 ERROR CODE APPEARED. IT IS SUSPECTED THAT THE HANDPIECE SHORTED THE SIU OR UPS. THE PROCEDURE WAS COMPLETED, WITH A SIGNIFICANT DELAY, USING MANUAL INSTRUMENTATION . NO FURTHER COMPLICATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15073496 ↗
• InjuryJun 11, 2022Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT, DURING NAVIO ASSISTED SURGERY, WHEN ON THE CUT SCREEN, A WARNING OF A HANDPIECE EXPOSURE CONTROL MOTOR FAILURE APPEARED. PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, BY CHANGING TO MANUAL. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14670340 ↗
• InjuryJun 11, 2022Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT, DURING NAVIO ASSISTED SURGERY, THE NAVIO HANDPIECE PRESENTED A "HOMING FAILURE" ERROR. PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, BY CHANGING TO MANUAL TECHNIQUE. AFTER THE CASE, THE NAVIO HANDPIECE FAILED THE TEST. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14670273 ↗
• MalfunctionJun 11, 2022Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING NAVIO ASSISTED SURGERY, THE NAVIO HANDPIECE PRESENTED A CONTINUOUS ERROR AFTER CALIBRATION. PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT SURGICAL DELAY, BY CHANGING TO MANUAL TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14670254 ↗
• MalfunctionJun 7, 2022Connection Problem; Connection Problem

  IT WAS REPORTED THAT, WHEN CALIBRATING THE NAVIO HANDPIECE DURING A NAVIO ASSISTED TKA SURGERY, THERE WERE SEVERAL ERROR MESSAGES STATING ¿CANNOT RECOGNIZE HANDPIECE". AFTER TROUBLE SHOOTING, THE HANDPIECE WAS CALIBRATED. THE CASE CONTINUED THROUGH PLANNING, MADE ANTERIOR FEMORAL BURR HOLES, TRIED TO ADVANCE TO MAKE THE TIBIAL BURR HOLES AND THE NAVIO FROZE. WHEN RETURNING TO THE PLANNING SCREEN, THE BUTTON WERE GREYED OUT AND COULD NOT CLICK ON THEM. AFTER REBOOTING THE NAVIO, THE HANDPIECE COULD NOT BE CALIBRATED. PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, BY CHANGING TO MANUAL PROCEDURE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14626574 ↗
• MalfunctionMay 25, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT, DURING PREVENTATIVE MAINTENANCE, THE FIXED SHAFT ON THE HINGE AT THE BOTTOM OF THE NAVIO HANDPIECE WAS RELEASED. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14497286 ↗
• MalfunctionMay 25, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT DURING A NAVIO PREVENTATIVE MAINTENANCE, THEY NOTICED THE RELEASE OF THE FIXED SHAFT AT THE BOTTOM OF THE NAVIO HANDPIECE HINGE. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14497255 ↗
• MalfunctionMay 14, 2022Retraction Problem; Mechanics Altered; Retraction Problem; Mechanics Altered

  IT WAS REPORTED THAT, DURING NAVIO PREVENTATIVE MAINTENANCE, THEY OCCASIONALLY RECEIVE "HANDPIECE EXPOSURE CONTROL MOTOR FAILURE" WARNING ERROR AND OCCASIONALLY HANDPIECE HOMING IS IMPOSSIBLE. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14403131 ↗
• MalfunctionApr 11, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT AFTER A NAVIO ASSISTED TKA SURGERY, THE SCREW TO SECURE THE NAVIO HANDPIECE WAS CROSS-THREADED AND UNABLE TO BE REMOVED. THE PROCEDURE WAS COMPLETED, WITHOUT ANY DELAY, AS THEY DID NOT LONGER NEED THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14072074 ↗
• MalfunctionApr 1, 2022Mechanics Altered; Physical Resistance/Sticking; Mechanics Altered; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING SET UP FOR A NAVIO ASSISTED TKA SURGERY THE NAVIO HANDPIECE GEARS LOCKED UP (MOTOR ISSUE). THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK-UP DEVICE. SINCE INCIDENT OCCURRED BEFORE PROCEDURE, PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13975589 ↗
• MalfunctionMar 28, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, DURING PREVENTATIVE MAINTENANCE, IT WAS FOUND THAT THE NAVIO HANDPIECE MOTOR SEIZED. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13927565 ↗
• MalfunctionMar 20, 2022Fracture; Fracture

  IT WAS REPORTED THAT WHEN THE NAVIO HANDPIECE WAS ASSEMBLED DURING SET UP FOR A NAVIO ASSISTED SURGERY, A NAVIO HANDPIECE THUMBERSCREW WAS FRACTURED. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13830685 ↗
• MalfunctionMar 17, 2022Fracture; Fracture

  IT WAS REPORTED THAT WHEN THE NAVIO HANDPIECE WAS ASSEMBLED DURING SET UP FOR A NAVIO ASSISTED SURGERY, THE NAVIO HANDPIECE THUMBERSCREW WAS FRACTURED. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13795888 ↗
• MalfunctionMar 2, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT WHEN THEY WENT TO BUR THE FEMORAL CONDYLE DURING A NAVIO ASSISTED SURGERY, THE FIRST ANSPACH DRILL WOULDN'T SPIN (THE HANDPIECE MOVED THE DRILL FORWARD BUT THE DRILL WOULDN'T SPIN). THEY CHECKED THE SURGEON WAS PRESSING THE BLACK PEDAL AND WERE ON "CUT FEMUR", UNPLUGGED THE DRILL AND TRIED AGAIN BUT THE DRILL WOULDN'T WORK. WHEN A SECOND DRILL AND LONG ATTACHMENT, AND THE SAME BURR WERE ADDED INTO THE FIRST HANDPIECE, THEY HAD NOT BEEN PUT TOGETHER PROPERLY, SO THEY FAILED CALIBRATION. UPON REMOVING THE SECOND DRILL FROM THE FIRST HANDPIECE, THE SECOND LONG ATTACHMENT GOT STUCK IN THE FIRST HANDPIECE AND COULDN'T BE REMOVED. THEREFORE, THE SURGEON WAS REPEATEDLY HIT WITH A MALLET, BREAKING THE FIRST HANDPIECE, AND POTENTIALLY DAMAGING THE SECOND LONG ATTACHMENT AND SECOND DRILL. THEY OPENED A SECOND HANDPIECE AND CONTINUED USING THE PREVIOUS DRILL 2 AND LONG ATTACHMENT 2, BUT THE NURSE FOUND IT DIFFICULT TO INSERT THE BURR INTO LONG ATTACHMENT (PREVIOUSLY DAMAGED WITH THE SURGEON'S HAMMERING), SO THE SURGEON HAMMERED IT IN. THE HANDPIECE THEN PASSED CALIBRATION AND THE SURGEON STARTED TO USE IT TO REMOVE BONE, BUT AT SOME POINT, THE BURR DETACHED FROM THE SECON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13653812 ↗
• MalfunctionFeb 28, 2022Break; Break

  IT WAS REPORTED THAT DURING A NAVIO DEMO, THE CLAMSHELL OF THE NAVIO HANDPIECE COULD NOT BE CLOSED DUE TO A SMALL SCREW NOT BEING SCREWED INCORRECTLY. THEY USED THE BLADE OF A STANLEY KNIFE TO SCREW UP THE SCREW, SO THE CLAMSHELL COULD BE CLOSED. AS THIS HAPPENED IN A DEMONSTRATION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13620814 ↗
• MalfunctionFeb 18, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A NAVIO ASSISTED SURGERY, IT WAS FOUND THAT THE THUMB SCREW OF A NAVIO HANDPIECE WAS FRACTURED. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT DELAY. THE PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13559109 ↗
• InjuryFeb 8, 2022Circuit Failure; Circuit Failure

  IT WAS REPORTED THAT, DURING THE PREPARATION FOR A NAVIO ASSISTED TKA SURGERY, THEY GOT AN ERROR MESSAGE DURING BUR HOMING SAYING "INTERNAL CABLING DRILL/CONSOLE ERROR". THEY UNPLUGGED THE NAVIO HANDPIECE AND REBOOTED THE MACHINE. AFTER START UP, THEY GOT AN ERROR SAYING "PFS CONTROL HARDWARE FAILURE". THE PROCEDURE WAS COMPLETED WITH MANUAL INSTRUMENTATION WITHOUT SIGNIFICANT DELAYS. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13480846 ↗
• MalfunctionFeb 8, 2022Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT, DURING A NAVIO TKA SURGERY, THE MOTOR OF THE NAVIO HANDPIECE SEEMED TO STOP AND SEIZE. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT DELAY. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13478570 ↗
• MalfunctionFeb 8, 2022Fracture; Fracture

  IT WAS REPORTED THAT WHEN THE NAVIO HANDPIECE WAS ASSEMBLED DURING SET UP FOR A NAVIO ASSISTED SURGERY, A SCREW WAS FRACTURED. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13478493 ↗
• MalfunctionJan 28, 2022Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT, DURING MACHINE SETUP FOR A NAVIO ASSISTED SURGERY, THE ERROR "HANDPIECE EXPOSURE CONTROL FAILURE" CAME ON THE SCREEN. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT SIGNIFICANT DELAYS. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13389621 ↗