Navio PFSR120010Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00885556628577), received between Aug 8, 2019 and Dec 10, 2021 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING A NAVIO ASSISTED UKR SURGERY, THE HANDPIECE WOULD NOT CALIBRATE. THEY SWITCHED TO NEW HANDPIECE AND FOUND THAT THERE WAS A ROCK IN THE NAVIO HANDPIECE TRACKER ARRAY WHEN PUTTING IT ON A FLAT SURFACE SUGGESTING THAT IT HAS BECOME DEFORMED. 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 12974704 ↗
• MalfunctionDec 7, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING SET UP FOR A NAVIO ASSISTED UKR, THEY WERE CALIBRATING THE HANDPIECE, AND BOTH THE HANDPIECE TEST AND DRILL TEST WERE RAN PRIOR TO CALIBRATION AND PASSED. WHEN ENTERING THE HANDPIECE CALIBRATION STAGE OF THE SOFTWARE, THE CAMERA COULD NOT SEE THE NAVIO HANDPIECE TRACKER ARRAY IN VIEW. IT WAS ABLE TO SEE THE PROBE, BUT NOT THE HANDPIECE. THEY RE-CHECKED THE HANDPIECE ASSEMBLY AND EVERYTHING CHECKED OUT AS PROPERLY ASSEMBLED. THEY MADE SURE ONCE AGAIN THAT ALL OF THE FLAT MARKERS WERE FLUSH, BUT THE CAMERA WAS STILL UNABLE SEE THE HANDPIECE ARRAY. THEN, THEY REPLACED THE FLAT MARKERS ON THE HANDPIECE ARRAY AND THE CAMERA WAS STILL NOT SEEING THE HANDPIECE ARRAY. DURING THIS TIME, AN ERROR POPPED UP ON THE SCREEN STATING "HANDPIECE ERROR". THEY CHECKED THE CABLES, UNPLUGGED AND REPLUGGED AND HIT DISMISS. THE ERROR DID NOT POP UP AGAIN (B)(4). THEN, THEY TRIED CALIBRATING AGAIN, BUT THE CAMERA WAS STILL NOT SEEING THE HANDPIECE ARRAY. THEY VISIBLY LOOKED AT THE HANDPIECE ARRAY AND IT APPEARED THAT IT MAY BE BENT. THEY GOT A NEW HANDPIECE ARRAY AND ASSEMBLED IT ONTO THE HANDPIECE. THE CAMERA WAS THEN ABLE TO SEE BOTH THE HANDPIECE ARRAY AND THE PROBE. THEN,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12957056 ↗
• InjuryApr 19, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT, DURING FEMUR CUTTING IN A NAVIO UKR PROCEDURE, THE HANDPIECE TRACKER ARRAY (CASE-(B)(4)) WAS LOOSE FROM THE HANDPIECE (CASE-(B)(4)); THUS, POSTERIOR FEMORAL CONDYLE WAS CUT EXTRA 3MM. THE BONE DEFECT WAS FILLED WITH BONE CEMENT. THERE WAS A DELAY FEWER THAN 30 MINUTES. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11684710 ↗
• MalfunctionApr 30, 2020Defective Component; Defective Component

  IT WAS REPORTED THAT BEFORE SURGERY, THE HANDPIECE TRACKER WAS BENT. THERE WAS A BACKUP DEVICE AVAILABLE AND A DELAY OF FEWER THAN 30 MINUTES. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10014738 ↗
• MalfunctionApr 25, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING LAB/DEMO, HANDPIECE ERROR APPEARED SAYING THAT THE DRILL HAS FAILED. THE BLACK ATTACHMENT ON THE MOVING MECHANISM SHEARED OFF, AND APPEARS TO HAVE CAUSED THE FAULT. TWO MORE HANDPIECES WERE TRIED, AND SEEMED TO HAVE POWER FAILURES AS WELL. THE HEALTHCARE PROFESSIONALS TRIED TO USE THEM ON THE STATIONS, AND THESE DIDN'T WORK EITHER, AND WHEN TESTED AFTERWARDS BOTH FAILED THE HANDPIECE TESTS. ALSO, HANDPIECE TRACKER FRAME WAS DROPPED FROM THE TABLE, AND WAS BENT. NO PATIENT INVOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9999253 ↗
• MalfunctionApr 24, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT WHILE ATTEMPTING TO CALIBRATE THE NAVIO HANDPIECE DURING A SAWBONE DEMO, AN ERROR OCCURRED SAYING "THE HANDPIECE CANNOT BE CALIBRATED." UPON TRYING SEVERAL OTHER TIMES WITH ANOTHER HANDPIECE THE ERROR STILL OCCURRED. THE HANDPIECE ARRAY WAS REMOVED AND LAID FACE DOWN ON THE TABLE. IT WAS OBSERVED THAT NOT ALL THE PRONGS WERE FLUSH WITH THE TABLE INDICATING THE TRACKER ARRAY WAS BENT. NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 9998885 ↗
• InjuryOct 30, 2019Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT AFTER SURGEON BURRED DISTAL FEMUR, HE BURRED HOLES FOR FEMORAL 4 IN ONE CUTTING BLOCK. HE THEN PUT THE CUTTING BLOCK SPIKES INTO THE BURRED HOLES AND USED THE VISUALIZATION TOOL TO NAVIGATE CUTTING BLOCK. WHEN THE BLOCK WAS CENTERED IN THE BURR HOLES THE CUT WAS PROUD BY ABOUT 10MM. THE SURGEON THEN NAVIGATED THE BLOCK APPROX 10MM POSTERIOR FROM THE BURR HOLES AND IT INDICATED IT WAS RIGHT ON PLAN. SO THE BURR HOLES WERE NOT IN CORRECT SPOT BUT APPROXIMATELY 10MM ANTERIOR. NOTED THAT DURING INITIAL BURRING OF DISTAL FEMUR IS WAS NOTICE THAT THE TRACKER ARRAYS WERE VERY LOOSE ON THE HANDPIECE AND WOULD NOT LET SURGEON BURR. ONCE TIGHTENED HE WAS ABLE TO BURR DISTAL FEMUR AND CONTINUE. SURGERY WAS COMPLETED USING VISUALIZATION TOOL TO NAVIGATE TO PLAN.

  Patient problems: Injury

  MAUDE report 9254538 ↗
• InjurySep 30, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT TRACKER FRAME ON HAND PIECE WAS LOOSE WHEN WE ARRIVED TO CUT PEG HOLES FOR FEMUR. SO THE DRILL SHOWED US THAT WE WERE RIGHT ON PEG HOLES, BUT WHEN SURGEON FINISHED DRILLING PEG HOLES HE VERIFIED IT WITH POINT PROBE AND THE POINT PROBE SHOWED ITSELF AT 3-4 MM SUPERIOR OF THE BOTH PEG HOLES (DIRECTLY NORTH). TRACKER ARRAY WAS THEN TIGHTENED AND THEN REVERIFIED WITH POINT PROBE AND IT WAS CORRECTED.

  Patient problems: Injury

  MAUDE report 9135141 ↗
• MalfunctionAug 8, 2019Break; Break

  IT WAS REPORTED THAT SCRUB TECH OVER-TIGHTENED ARRAY TO NAVIO HANDPIECE USING T-WRENCH AND BROKE ONE OF THE TWO ATTACHMENT SCREWS SO THAT THE SCREW HEAD CAME OFF BUT THE BODY REMAINED IN ITS HOLE... WAS ABLE TO PROCEED WITH SURGERY BECAUSE THE ARRAY WAS STILL FASTENED TIGHTLY WITH THE ONE OTHER SCREW. NO INJURY INVOLVED. DELAY OF LESS THAN 30 MINUTES INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8875655 ↗