NAVIO PFSR100026Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 20885556648425), received between May 18, 2020 and Sep 3, 2023 — classified as 3 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Fracture” (33 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 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING NAVIO ASSISTED SURGERY, THE NAVIO HANDPIECE THUMBERSCREW BROKE DURING THE INSTALLATION. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH 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 17675056 ↗
• InjuryNov 7, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING THE SET-UP FOR NAVIO ASSISTED SURGERY, A NAVIO HANDPIECE THUMBERSCREW WAS NOTICED FRACTURED. THEN, WHEN USING A BACK-UP SCREW, IT WAS NOT POSSIBLE TO INSERT IT TO THE NAVIO HANDPIECE TRACKER ARRAY. SURGERY WAS PERFORMED WITH A COMPETITOR'S NAVIGATION SYSTEM. NO DELAYS OR PATIENT INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15748370 ↗
• MalfunctionJul 21, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING MACHINE SETUP FOR A NAVIO ASSISTED TKA PROCEDURE, IT WAS FOUND THAT THE NAVIO HANDPIECE THUMBERSCREW WAS BROKEN. THE SURGERY PROCEEDED, WITHOUT DELAY, USING A THUMBSCREW FROM THE PADDY. SINCE INCIDENT OCCURRED BEFORE PROCEDURE, PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15076835 ↗
• MalfunctionApr 6, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING SET UP FOR A NAVIO ASSISTED SURGERY, THE NAVIO HANDPIECE THUMBERSCREW WAS BROKEN. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK-UP DEVICE. SINCE INCIDENT OCCURRED BEFORE PROCEDURE, THE PATIENT WAS NOT INVOLVED AT THE MOMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14021824 ↗
• MalfunctionMar 8, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A NAVIO ASSISTED TKA SURGERY, THE NAVIO HANDPIECE THUMBERSCREW WAS FRACTURED. NO PIECE FELL INSIDE THE PATIENT. 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 13694427 ↗
• MalfunctionFeb 1, 2022Fracture; Peeled/Delaminated; Fracture; Peeled/Delaminated

  IT WAS REPORTED THAT DURING SET UP FOR A NAVIO ASSISTED SURGERY THE NAVIO HANDPIECE THUMBERSCREW WAS PEELED AND PIECES BROKE OFF. 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 13419093 ↗
• MalfunctionJan 12, 2022Break; Break

  IT WAS REPORTED THAT, DURING MACHINE SETUP FOR A NAVIO ASSISTED SURGERY, IT WAS FOUND THAT TWO NAVIO HANDPIECE THUMBERSCREWS WERE BROKEN. 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 13236670 ↗
• MalfunctionJan 12, 2022Break; Break

  IT WAS REPORTED THAT, DURING MACHINE SETUP FOR A NAVIO ASSISTED SURGERY, IT WAS FOUND THAT TWO NAVIO HANDPIECE THUMBERSCREWS WERE BROKEN. 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 13236653 ↗
• MalfunctionDec 30, 2021Fracture; Fracture

  IT WAS REPORTED THAT AFTER A NAVIO-ASSISTED SURGERY, THE NAVIO HANDPIECE THUMBERSCREW WAS FOUND TO BE BROKEN. SINCE INCIDENT OCCURRED AFTER PROCEDURE, PATIENT WAS NOT LONGER INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13117507 ↗
• MalfunctionDec 14, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING SET UP FOR A NAVIO ASSISTED TKA, THE NAVIO HANDPIECE THUMBERSCREW WAS FRACTURE. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK-UP DEVICE. SINCE INCIDENT OCCURRED BEFORE PROCEDURE, PATIENT WAS NOT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13002449 ↗
• MalfunctionNov 30, 2021Fracture; Fracture

  IT WAS REPORTED THAT, AFTER CLEANING, IT WAS FOUND THAT THE NAVIO HANDPIECE THUMBERSCREW FRACTURED. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12894553 ↗
• MalfunctionNov 24, 2021Fracture; Fracture

  IT WAS REPORTED THAT, DURING A NAVIO LAB/DEMO, WHEN THEY WERE ASSEMBLING THE HANDPIECE TRACKER ONTO THE HANDPIECE, THE NAVIO HANDPIECE THUMBERSCREW BROKE OFF WHILE TIGHTENING WITH THE T-HANDLE WRENCH. THERE WERE NO REPLACEMENT THUMBSCREW PIECES IN THE BIN, BUT THEY WERE STILL ABLE TO USE IT BY TAPING THE TRACKER TO THE HANDPIECE. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12869350 ↗
• MalfunctionNov 22, 2021Fracture; Fracture

  IT WAS REPORTED THAT, DURING SET UP AND HANDPIECE ASSEMBLY FOR A NAVIO ASSISTED TKA SURGERY, ONE OF THE NAVIO HANDPIECE THUMBERSCREW BROKE OFF DURING GENTLE TIGHTENING. 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 12852103 ↗
• MalfunctionNov 18, 2021Fracture; Fracture

  IT WAS REPORTED THAT, DURING SET UP FOR A NAVIO ASSISTED SURGERY, THE NAVIO HANDPIECE THUMBERSCREW WAS FRACTURED. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT DELAY. SINCE INCIDENT OCCURRED BEFORE PROCEDURE, PATIENT WAS NOT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12839853 ↗
• MalfunctionSep 15, 2021Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A NAVIO-ASSISTED SURGERY, THE NAVIO HANDPIECE THUMBERSCREW WAS FOUND FRACTURED. THERE WAS NO DELAY. SINCE INCIDENT OCCURRED AFTER THE PROCEDURE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12474746 ↗
• MalfunctionAug 16, 2021Fracture; Fracture

  IT WAS REPORTED THAT, DURING MACHINE SET UP FOR A NAVIO-ASSISTED SURGERY, IT WAS FOUND THAT THE BURR WAS NOT PASSING SMOOTHLY FROM THE NAVIO LONG ATTACHMENT. ALSO THE NAVIO HANDPIECE THUMBERSCREW ON THE HANDPIECE WAS FAULTY (CHIPPED) AS THE THREADINGS WERE NOT GETTING TIGHTENED. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICES WITHOUT SIGNIFICANT DELAYS. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12328929 ↗
• InjuryJul 28, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A SET UP FOR A NAVIO ASSISTED SURGERY, IT WAS NOTICED THAT 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 12243503 ↗
• MalfunctionJul 21, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A SET UP FOR NAVIO ASSISTED SURGERY, THE NAVIO HANDPIECE THUMBERSCREW WAS FRACTURED DURING TIGHTENING IT. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY USING A BACK UP SCREW. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12203513 ↗
• MalfunctionJul 21, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT, DURING MACHINE SET UP FOR A NAVIO-ASSISTED SURGERY, IT WAS FOUND THAT THE NAVIO BONE PIN 4.0MMX152MM ((B)(4)), THE NAVIO BONE PIN 4.0MM X 127MM ((B)(4)) AND THE NAVIO HANDPIECE THUMBERSCREW ((B)(4)) HAD LOST THE THREADINGS. NO DELAYS WERE REPORTED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12203414 ↗
• MalfunctionJul 5, 2021Break; Break

  IT WAS REPORTED THAT DURING SET UP FOR A NAVIO ASSISTED SURGERY, IT WAS NOTICES THAT NAVIO BONE PIN 4.0MMX152MM (CASE-(B)(4)), NAVIO BONE PIN 4.0MM X 127MM (CASE-(B)(4)) AND NAVIO HANDPIECE THUMBERSCREW (CASE-(B)(4)) HAD LOST THEIR THREADINGS. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY AND HOW THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12114823 ↗
• MalfunctionJun 15, 2021Fracture; Fracture

  IT WAS REPORTED THAT, DURING A NAVIO-ASSISTED SURGERY, THE NAVIO HANDPIECE THUMBERSCREW FRACTURED EASILY WHEN THE SURGEON TIGHTENED IT. 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 12000894 ↗
• MalfunctionMay 26, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING SET UP FOR A NAVIO ASSISTED UKR SURGERY THE NAVIO HANDPIECE THUMBERSCREW WAS BROKEN DURING TIGHTENING. THEY WERE ABLE TO REPLACE THE THUMBSCREW AND RETRIEVE BROKE COMPONENTS. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK-UP DEVICE. AS THIS EVENT WAS PRIOR TO SURGERY, THERE WAS NO PATIENT INVOLVEMENT. THIS IS THE FIRST OF TWO EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11890099 ↗
• MalfunctionMay 26, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING SET UP FOR A NAVIO ASSISTED UKR SURGERY THE NAVIO HANDPIECE THUMBERSCREW WAS BROKEN DURING TIGHTENING. THEY WERE ABLE TO REPLACE THE THUMBSCREW AND RETRIEVE BROKE COMPONENTS. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK-UP DEVICE. AS THIS EVENT WAS PRIOR TO SURGERY, THERE WAS NO PATIENT INVOLVEMENT. THIS IS THE SECOND OF TWO EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11890096 ↗
• MalfunctionMay 19, 2021Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT DURING SET UP FOR A NAVIO ASSISTED TKA SURGERY THE NAVIO HANDPIECE THUMBERSCREW WAS BROKEN. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK-UP DEVICE. NO PATIENT INJURIES AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11852688 ↗
• MalfunctionMay 18, 2021Fracture; Fracture

  IT WAS REPORTED THAT, DURING A SET-UP FOR A NAVIO-ASSISTED SURGERY, THE NAVIO HANDPIECE THUMBERSCREW BROKE WHILE TIGHTENING THE TRACKER FRAME ONTO THE NAVIO HANDPIECE. THERE WAS NO SIGNIFICANT DELAYS (FEWER THAN 30 MINUTES) AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK-UP DEVICE. NO PATIENT WAS HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11841686 ↗