Navio PFSR110006Recalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 00885556628607), received between Apr 22, 2020 and Jun 25, 2022 — classified as 9 injuries, 57 malfunctions.

The most frequently reported specific device problem is “Break” (19 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 66 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2022Difficult to Insert; Unintended Movement; Difficult to Insert; Unintended Movement

  IT WAS REPORTED THAT, WHILE SETTING UP FOR A NAVIO ASSISTED UKR SURGERY, THEY WERE UNABLE TO INSERT THE BURR DOWN THE NAVIO LONG ATTACHMENT. THEY TRIED TO INSERT THE BURR FROM BOTH ENDS WITH NO LUCK. IT WAS DETERMINED TO BE AN ISSUE WITH THE BALL BEARINGS INSIDE THE LONG ATTACHMENT. 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 14819153 ↗
• MalfunctionJun 10, 2022Difficult to Insert; Unintended Movement; Difficult to Insert; Unintended Movement

  IT WAS REPORTED THAT, DURING SET UP FOR A NAVIO-ASSISTED TKA SURGERY, THE NAVIO HANDPIECE AND THE ANSPACH EMAX 2 PLUS HAND PIECE - ROHS DID NOT CONNECT TO THE NAVIO. BOTH DEVICES WERE UNPLUGGED AND PLUGGED IN SEVERAL TIMES, THE SYSTEM WAS REBOOTED; AND EVENTUALLY THEY OPENED ANOTHER TRAY AND PROCEEDED WITHOUT ISSUE. HOWEVER, THEY COULD NOT GET THE BURR TO SEAT IN THE NAVIO LONG ATTACHMENT, SO THEY TRIED THE ONE FROM THE SECOND SET AND IT ATTACHED AND THE BURR SEATED. THE PROCEDURE WAS FINISHED WITH SMITH AND NEPHEW BACK UP DEVICES WITHOUT DELAYS. THE PATIENT WAS NOT HARMED. THE INVESTIGATION STATED THAT THE MOST PROBABLE CAUSE OF THE NAVIO HANDPIECE CONNECTION PROBLEM IS A ELECTRICAL FAILURE WITHIN HANDPIECE CABLE. ALSO, IT WAS FOUND THAT THERE WAS A BEARING LOOSE INSIDE OF THE SHAFT OF THE NAVIO LONG ATTACHMENT, AND THESE TWO FINDINGS MAKE THESE REPORTABLE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14655166 ↗
• MalfunctionMar 2, 2022Difficult to Insert; Physical Resistance/Sticking; Difficult to Insert; 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 13653875 ↗
• MalfunctionJan 18, 2022Material Deformation; Unintended Movement; Material Deformation; Unintended Movement

  IT WAS REPORTED THAT, DURING FEMORAL BURRING IN A NAVIO ASSISTED TKA SURGERY, THE HANDPIECE WAS MAKING A LOUD SCREECHING NOISE. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING THE SAME DEVICE, AND THE PATIENT WAS NOT HARMED. AFTER THE CASE, DURING INSTRUMENT DISASSEMBLY, IT WAS NOTICED THAT THE DISTAL TIP OF THE NAVIO LONG ATTACHMENT, WHERE THE BUR IS INSERTED, WAS FLARED OUT. THE INVESTIGATION FOUND THAT THE LONG ATTACHMENT WAS NOT FACILITATING THE BUR LOADING DUE TO LOOSE BEARINGS WITHIN THE DEVICE, CAUSING AN OBSTRUCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13282365 ↗
• MalfunctionJan 4, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT, DURING THE MILLING STAGE IN A NAVIO ASSISTED SURGERY, IT WAS FOUND THAT THERE WERE BLACK FUMES COMING FROM THE DRILL. THE NAVIO LONG ATTACHMENT AND EXPOSURE CONTROL GUARD BECAME HOT. THE SURGERY WAS CONTINUED, WITHOUT SIGNIFICANT DELAYS, USING THE NAVIO LONG ATTACHMENT FROM OTHER SET AND WITH THE SAME TECHNIQUE. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13152351 ↗
• MalfunctionDec 30, 2021Break; Break

  IT WAS REPORTED THAT, DURING SET UP FOR A NAVIO ASSISTED TKA SURGERY, THE NAVIO LONG ATTACHMENT BROKE. 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 13117568 ↗
• MalfunctionJul 28, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT, DURING A NAVIO ASSISTED TKA PROCEDURE, IT WAS FOUND THAT THE LONG ATTACHMENT FAILED TO ACCEPT THE BURR (IT WAS NOT PASSING SMOOTHLY). THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF FEWER THAN 30 MINUTES USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. THE INVESTIGATION FOUND THAT THERE WAS A BEARING LOOSE INSIDE OF THE SHAFT OF THE LONG ATTACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12235915 ↗
• InjuryJul 6, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT, DURING A NAVIO-ASSISTED UKR SURGERY, THE ANSPACH BUR DID NOT WORK, THEY THINK IT IS BECAUSE IT DID NOT ENTER EASILY THROUGH THE NAVIO LONG ATTACHMENT. IT WAS TESTED WITH 2 UNITS OF LONG ATTACHMENT WITHOUT SUCCESS. THE PROCEDURE WAS COMPLETED WITH MANUAL INSTRUMENTATION WITHOUT SIGNIFICANT DELAY (LESS THAN 30 MINUTES). THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12125490 ↗
• InjuryJul 6, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT, DURING A NAVIO-ASSISTED UKR SURGERY, THE ANSPACH BUR DID NOT WORK, THEY THINK IT IS BECAUSE IT DID NOT ENTER EASILY THROUGH THE NAVIO LONG ATTACHMENT. IT WAS TESTED WITH 2 UNITS OF LONG ATTACHMENT WITHOUT SUCCESS. THE PROCEDURE WAS COMPLETED WITH MANUAL INSTRUMENTATION WITHOUT SIGNIFICANT DELAY (LESS THAN 30 MINUTES). THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12125487 ↗
• MalfunctionJun 28, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A NAVIO ASSISTED UKR SURGERY, AFTER THE SURGEON BEGAN BURRING THE FEMUR, THE BUR STOPPED BURRING MOMENTS AFTER CUTTING. THEY TRIED TO REMOVE THE DRILL FROM THE HAND PIECE, BUT THE DRILL WAS STUCK TO THE HAND PIECE. ALSO, THE BUR WAS STUCK IN THE LONG ATTACHMENT. THE PROCEDURE WAS COMPLETED, WITH A DELAY OF LESS THAN 30 MINUTES, BY SWAPPING THE EQUIPMENT FOR A NEW HAND PIECE, DRILL AND LONG ATTACHMENT. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12080977 ↗
• InjuryMay 26, 2021Break; Misassembly by Users; Break; Misassembly by Users

  IT WAS REPORTED THAT, DURING A NAVIO-ASSISTED TKA SURGERY, THE NAVIO LONG ATTACHMENT MADE IT DIFFICULT TO INSERT THE SPHERICAL DRILL INTO ITS PLACE AND LOCK IT ON THE HANDPIECE. THE PROCEDURE WAS FINISHED WITH MANUAL INSTRUMENTATION WITHOUT SIGNIFICANT DELAYS (FEWER THAN 30 MINUTES). THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11891111 ↗
• MalfunctionMay 7, 2021Break; Difficult to Insert; Break; Difficult to Insert

  IT WAS REPORTED THAT, DURING NAVIO PREVENTATIVE MAINTENANCE, THEY FOUND THAT IT WAS SO CHALLENGING TO GET THE BURR DOWN THROUGH THE APERTURE IN THE LONG ATTACHMENT DUE TO AN ISSUE WITH THE INTERNAL BUSHING/BEARING GOING. THERE WAS NO PATIENT INVOLVEMENT. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11789905 ↗
• MalfunctionMay 4, 2021Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT, DURING A NAVIO TKA PROCEDURE, THE INSERTION OF AN ANSPACH CUTTER L-5B INTO THE LONG ATTACHMENT REVEALED A RESISTANCE THAT COULD HARDLY BE OVERCOME AND REVEALED A SPIRAL-SHAPED MATERIAL, THERE WAS POSSIBLY METAL DEBRIS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11773470 ↗
• MalfunctionApr 1, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING INSTRUMENT DISASSEMBLY AFTER A NAVIO TKA PROCEDURE, THEY WERE UNABLE TO REMOVE THE BUR FROM THE LONG ATTACHMENT. THEY WERE FINALLY ABLE TO GET THE BUR OUT. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11605340 ↗
• MalfunctionMar 22, 2021Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A NAVIO TKA PROCEDURE, DURING INSTRUMENT DISASSEMBLY, THE LONG ATTACHMENT CAME APART INTO TWO PIECES. THERE WERE NO ISSUES DURING THE PROCEDURE. THERE WAS NO FORCE APPLIED WHILE DISASSEMBLING. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11544050 ↗
• MalfunctionMar 12, 2021Break; Break

  IT WAS REPORTED THAT BEFORE A TKA PROCEDURE, THE LONG ATTACHMENT WOULD NOT PROPERLY ATTACH TO THE HANDPIECE. THEY OPENED OPEN ANOTHER TRAY TO GET A NEW LONG ATTACHMENT THAT WOULD WORK TO CONTINUE THE PROCEDURE WITHOUT DELAY. NO OTHER COMPLICATIONS WERE REPORTED. THE INVESTIGATION FOUND THAT THE INTERNAL BEARINGS ARE DISINTEGRATED CAUSING AN OBSTRUCTION IN THE LONG ATTACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11478055 ↗
• MalfunctionMar 4, 2021Break; Break

  IT WAS REPORTED THAT DURING A NAVIO UKR PROCEDURE, THE LONG ATTACHMENT WOULD NOT LET BURR GO THROUGH IT. IT WAS SWAPPED FOR ITS BACKUP TO CONTINUE WITH A DELAY OF FEWER THAN 30 MINUTES. NO OTHER COMPLICATIONS WERE REPORTED. IT WAS FOUND DURING INVESTIGATION THAT THE INTERNAL BEARINGS ARE DISINTEGRATED CAUSING AN OBSTRUCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11413942 ↗
• MalfunctionMar 1, 2021Break; Difficult to Insert; Break; Difficult to Insert

  IT WAS REPORTED THAT BEFORE A NAVIO TKA PROCEDURE, IT WAS FOUND THAT THE BUR WAS NOT ABLE TO FIT THROUGH THE LONG ATTACHMENT. THEY REPLACED THE LONG ATTACHMENT WITH ITS BACKUP FROM A DIFFERENT TRAY TO CONTINUE THE PROCEDURE WITHOUT DELAYS. NO OTHER COMPLICATIONS WERE REPORTED. THE INVESTIGATION FOUND THAT THE INTERNAL BEARINGS DISINTEGRATED CAUSING AN OBSTRUCTION IN THE LONG ATTACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11392086 ↗
• MalfunctionMar 1, 2021Break; Failure to Align; Break; Failure to Align

  IT WAS REPORTED THAT BEFORE A NAVIO TKA PROCEDURE, THEY COULD NOT GET THE BUR THROUGH THE LONG ATTACHMENT. IT WAS SWAPPED FOR ITS BACKUP TO CONTINUE THE PROCEDURE WITHOUT DELAYS. NO OTHER COMPLICATIONS WERE REPORTED. THE INVESTIGATION FOUND THAT THE INTERNAL BEARINGS ARE DISINTEGRATED CAUSING AN OBSTRUCTION IN THE LONG ATTACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11391991 ↗
• MalfunctionJan 28, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING BURRING OF THE DISTAL FEMUR IN A NAVIO TKA PROCEDURE, THEY WERE ABLE TO COMPLETE ABOUT 70-75% OF THE BONY RESECTION WHEN THE LONG ATTACHMENT OVERHEATED. THEY WERE STILL ABLE TO COMPLETE THE BURRING WITH THE SAME DEVICES WITHOUT ANY DELAY OR HARM TO THE PATIENT. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11242511 ↗
• InjuryJan 4, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING A NAVIO UKR PROCEDURE, WHEN THE SURGEON WENT TO BUR, THE BUR WOULD NOT SPIN OR COME OUT OF THE GUARD: THE ANSPACH DRILL WAS LOCKED IN. THEY OPENED THE HANDPIECE CLAMSHELL AND CHECKED THE GEARS WERE MOVING FREELY, UNSEATED THE LONG ATTACHMENT AND THE BUR, RESEATED THEM AND WENT BACK TO RECALIBRATE, BUT THE HANDPIECE WOULD NOT HOME. IT IS UNKNOWN WHETHER WHICH DEVICE CAUSED THE PROBLEM. THE SURGERY WAS CHANGED TO MANUAL PROCEDURE WITH A DELAY OF FEWER THAN 30 MINUTES. NO OTHER COMPLICATION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11113801 ↗
• MalfunctionJan 4, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT, WHEN THE HANDPIECE WAS BEING ASSEMBLED BEFORE A NAVIO UKR PROCEDURE, THE BURR WOULD NOT SLIDE DOWN THE LONG ATTACHMENT AND THEN IT BECAME STUCK IN THE LONG ATTACHMENT. THEY TRIED TO PUSH THE STUCK BUR OUT THE OTHER DIRECTION, BUT WERE NOT SUCCESSFUL. THEY SWAPPED IT FOR ITS BACK-UP TO PROCEED WITH A DELAY OF FEWER THAN 30 MINUTES. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11113788 ↗
• MalfunctionDec 29, 2020Break; Break

  IT WAS REPORTED THAT THE STERILIZATION PROCESS DEPARTMENT FOUND A NAVIO LONG ATTACHMENT THAT SEEMS TO HAVE AN INTERNAL ISSUE. WITHOUT BEING CONNECTED TO A DRILL AND ATTEMPTING TO INSERT A BUR, IT TAKES A LOT OF EFFORT TO GET THE BUR INTO THE LONG ATTACHMENT. ONCE THE BUR WAS INSERTED, THERE WAS A FEELING OF RESISTANCE/CATCHING. NO PATIENT WAS INVOLVED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11089810 ↗
• MalfunctionNov 20, 2020Break; Break

  IT WAS REPORTED THAT, WHEN ASSEMBLING THE HANDPIECE BEFORE A NAVIO TKA PROCEDURE, THEY WERE UNABLE TO GET THE BUR TO FIT THROUGH THE LONG ATTACHMENT. THERE WAS SOME OBSTRUCTION. IT WAS SWAPPED FOR ITS BACKUP TO PROCEED WITHOUT DELAY. NO OTHER COMPLICATIONS WERE REPORTED.

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

  MAUDE report 10875657 ↗
• MalfunctionNov 4, 2020Break; Break

  IT WAS REPORTED THAT, BEFORE A NAVIO TKA PROCEDURE, THE BUR COULD NOT BE INSERTED INTO THE LONG ATTACHMENT. THEY TRIED BOTH WAYS JUST TO MAKE SURE. IT LOOKS LIKE THE INTERNAL PARTS HAVE SHIFTED TO BLOCK THE ENTRY. THERE WAS A DELAY OF FEWER THAN 30 MINUTES. IT WAS SWAPPED FOR ITS BACKUP TO PROCEED. NO PATIENT WAS INVOLVED AT THE MOMENT. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10784418 ↗