Navio PFSR110164Recalls & reported problems

Summary

The FDA's MAUDE database contains 147 adverse event reports that list this exact device (DI 00885556628614), received between Aug 8, 2019 and Jun 8, 2022 — classified as 25 injuries, 122 malfunctions.

The most frequently reported specific device problem is “Solder Joint Fracture” (92 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 147 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2022Solder Joint Fracture; Solder Joint Fracture

  IT WAS REPORTED THAT, DURING CORI ASSISTED UKR SURGERY, WHILE USING NAVIO DRIVER AND CORI PINS, THE NAVIO DRIVER BROKE, EXTERNAL TO THE PATIENT. ALL PIECES WERE RECOVERED. PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14629544 ↗
• MalfunctionJun 8, 2022Solder Joint Fracture; Solder Joint Fracture

  IT WAS REPORTED THAT, DURING CORI ASSISTED UKR SURGERY, WHILE USING NAVIO DRIVER AND CORI PINS, THE NAVIO DRIVER BROKE, EXTERNAL TO THE PATIENT. ALL PIECES WERE RECOVERED. PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14629536 ↗
• MalfunctionMay 19, 2022Solder Joint Fracture; Solder Joint Fracture

  IT WAS REPORTED THAT DURING A CORI ASSISTED UKR SURGERY, THE NAVIO BONE SCREW DRIVER BROKE. NOTHING BROKE INSIDE THE PATIENT'S BODY, AND ALL PIECES WERE RETRIEVED. THE PROCEDURE WAS COMPLETED, WITH A NON-SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED BEYOND THE PROBLEM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14435971 ↗
• MalfunctionApr 17, 2022Solder Joint Fracture; Solder Joint Fracture

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA, TWO NAVIO BONE SCREW DRIVERS BROKE WHILE USING THEM. ALL PIECES WHERE RETRIEVED. PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14132108 ↗
• MalfunctionApr 1, 2022Solder Joint Fracture; Solder Joint Fracture

  IT WAS REPORTED THAT AFTER A NAVIO ASSISTED SURGERY, THE NAVIO BONE SCREW DRIVER BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY DELAY, AS THEY DID NOT LONGER NEED THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13983082 ↗
• MalfunctionMar 18, 2022Solder Joint Fracture; Solder Joint Fracture

  IT WAS REPORTED THAT, DURING SET UP FOR A NAVIO ASSISTED TKA SURGERY, IT WAS NOTICED THAT THE NAVIO BONE SCREW DRIVER WAS STRIPPED FROM CONTINUOUS USE AND WOULD NOT HOLD THE PINS ANY MORE. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT DELAYS. SINCE INCIDENT OCCURRED BEFORE PROCEDURE, PATIENT WAS NOT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13815307 ↗
• MalfunctionFeb 10, 2022Solder Joint Fracture; Solder Joint Fracture

  IT WAS REPORTED THAT, DURING A NAVIO ASSISTED TKA SURGERY, THE NAVIO BONE SCREW DRIVER SPUN FREELY AND DID NOT GRIP AND DRIVE THE PIN. A JACOBS CHUCK WAS USED TO DRIVE THE PINS. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT DELAY. NO PATIENT HARMED WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13510593 ↗
• MalfunctionJan 18, 2022Solder Joint Fracture; Solder Joint Fracture

  IT WAS REPORTED THAT, DURING PIN PLACEMENT IN A NAVIO ASSISTED TKA SURGERY, THE NAVIO BONE SCREW DRIVER WAS STRIPPED AND BROKEN. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITH MINIMAL DELAY. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13287170 ↗
• MalfunctionJan 18, 2022Solder Joint Fracture; Solder Joint Fracture

  IT WAS REPORTED THAT DURING A NAVIO ASSISTED TKA SURGERY, THE NAVIO BONE SCREW DRIVER BROKE AND STRIPPED. ALL PIECES WERE RETRIEVED. NOTHING FELL IN PATIENT. THE PROCEDURE WAS COMPLETED, WITH A NON-SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13287060 ↗
• MalfunctionDec 27, 2021Solder Joint Fracture; Solder Joint Fracture

  IT WAS REPORTED THAT DURING A NAVIO ASSISTED TKA SURGERY, THE NAVIO BONE SCREW DRIVER SPINS FREELY, DOES NOT GRIP AND DRIVE THE PIN. THE PROCEDURE WAS COMPLETED, WITH A NON-SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED BEYOND THE PROBLEM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13088028 ↗
• InjuryDec 22, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A NAVIO ASSISTED TKA SURGERY, THE NAVIO BONE SCREW DRIVER WAS NOT SPINNING THE PINS. THE PROCEDURE WAS COMPLETED, WITH A NON-SIGNIFICANT DELAY, USING A PIN DRIVER FROM THE JOURNEY II TRAYS. PATIENT WAS NOT HARMED BEYOND THE PROBLEM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13060458 ↗
• MalfunctionDec 21, 2021Solder Joint Fracture; Solder Joint Fracture

  IT WAS REPORTED THAT DURING TKA SURGERY, THE NAVIO BONE SCREW DRIVER WAS BROKEN. THEY HAD TO REMOVE THE BONE PINS FROM THE PATIENT'S BONE USING A JACOBS CHUCK (COMPETITOR DEVICE). THE PROCEDURE WAS COMPLETED, WITH A NON-SIGNIFICANT DELAY, USING THE COMPETITOR DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13052883 ↗
• MalfunctionDec 15, 2021Solder Joint Fracture; Solder Joint Fracture

  IT WAS REPORTED THAT, DURING A NAVIO ASSISTED TKA SURGERY, THE NAVIO BONE SCREW DRIVER SPUN FREELY AND DID NOT GRIP AND DRIVE THE PIN. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. A NON-SIGNIFICANT DELAY WAS REPORTED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13011070 ↗
• MalfunctionDec 10, 2021Solder Joint Fracture; Solder Joint Fracture

  IT WAS REPORTED THAT, DURING A CORI ASSISTED UKR SURGERY, THE SURGEON USED A NAVIO BONE SCREW DRIVER AND THE DRIVER BROKE. ALL THE PIECES WERE RETRIEVED AND NOTHING FELL IN THE PATIENT. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT SIGNIFICANT DELAYS. THE PATIENT WAS NOT HARMED DUE TO THE REPORTED PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12974530 ↗
• InjuryDec 6, 2021Solder Joint Fracture; Solder Joint Fracture

  IT WAS REPORTED THAT DURING A NAVIO ASSISTED TKA SURGERY, THE NAVIO BONE SCREW DRIVER WAS STRIPPED AND NO LONGER HELD PINS. THE PROCEDURE WAS COMPLETED, WITH A NON-SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED BEYOND THE PROBLEM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12938996 ↗
• MalfunctionNov 30, 2021Solder Joint Fracture; Solder Joint Fracture

  IT WAS REPORTED, DURING A NAVIO ASSISTED UKR SURGERY, THE NAVIO BONE SCREW DRIVER WAS FOUND TO BE FAULTY. THE INTERNAL THREAD OF THE PIN DRIVER WAS NOT FIXED, SO THE PINS WERE HELD IN THE PIN DRIVER BUT WOULD NOT SPIN. THE PROCEDURE WAS COMPLETED, WITH A NON-SIGNIFICANT DELAY, USING ANOTHER PIN DRIVER. PATIENT WAS NOT HARMED DUE TO THE PROBLEM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12898021 ↗
• MalfunctionNov 24, 2021Solder Joint Fracture; Solder Joint Fracture

  IT WAS REPORTED THAT, WHILE PLACING THE PINS DURING A NAVIO ASSISTED TKA SURGERY, THE NAVIO BONE SCREW DRIVER BROKE. ALL THE PIECES WERE RETRIEVED. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT DELAY. THE PATIENT WAS NOT HARMED DUE TO THE REPORTED PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12870259 ↗
• MalfunctionNov 23, 2021Solder Joint Fracture; Solder Joint Fracture

  IT WAS REPORTED THAT, DURING SET UP FOR A NAVIO ASSISTED TKA SURGERY, THE NAVIO BONE SCREW DRIVER WAS STRIPPED AT THE LOCKING MECHANISM AND WOULD NOT HOLD ON TO OR INSERT NAVIO BONE SCREWS. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT DELAYS. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12864306 ↗
• MalfunctionNov 22, 2021Solder Joint Fracture; Solder Joint Fracture

  IT WAS REPORTED THAT, DURING SET UP FOR A NAVIO ASSISTED TKA SURGERY, IT WAS NOTICED THAT THE NAVIO BONE SCREW DRIVER WAS STRIPPED AND CAN NOT SECURELY HOLD NAVIO PINS. 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 12852142 ↗
• MalfunctionNov 15, 2021Solder Joint Fracture; Solder Joint Fracture

  IT WAS REPORTED THAT DURING A NAVIO ASSISTED TKA SURGERY, WHILE DRIVING IN THE FIRST BONE PINS, THE INNER CYLINDER OF THE NAVIO BONE SCREW DRIVER CAME OUT OF THE DRIVER, MAKING THE PIN DRIVER NOT USEABLE ANYMORE. THE PROCEDURE WAS COMPLETED, WITH A NON-SIGNIFICANT DELAY, USING A BACK-UP DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12812271 ↗
• MalfunctionNov 11, 2021Solder Joint Fracture; Solder Joint Fracture

  IT WAS REPORTED THAT, DURING SET UP FOR A NAVIO ASSISTED TKA SURGERY, THE NAVIO BONE SCREW DRIVER LOCKING MECHANISM BECAME LOOSE AND DID NOT HOLD THE NAVIO PINS SECURELY. 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 12799573 ↗
• MalfunctionNov 11, 2021Solder Joint Fracture; Solder Joint Fracture

  IT WAS REPORTED THAT, DURING A NAVIO ASSISTED TKA SURGERY, THE NAVIO BONE SCREW DRIVER BROKE FREE. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT DELAYS. THE PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12795827 ↗
• MalfunctionNov 10, 2021Solder Joint Fracture; Solder Joint Fracture

  IT WAS REPORTED THAT DURING A CORI ASSISTED TKA SURGERY, THE NAVIO BONE SCREW DRIVER BROKE DURING CASE. ALL PIECES RETAINED AND NO PIECES FELL IN PATIENT. THE PROCEDURE WAS COMPLETED, WITH A NON-SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12790741 ↗
• MalfunctionOct 30, 2021Solder Joint Fracture; Solder Joint Fracture

  IT WAS REPORTED THAT DURING SET UP FOR A NAVIO ASSISTED TKA SURGERY, THE NAVIO BONE SCREW DRIVER WAS BROKEN AND WOULD NOT HOLD THE NAVIO PINS PROPERLY. 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 12725466 ↗
• MalfunctionOct 6, 2021Solder Joint Fracture; Solder Joint Fracture

  IT WAS REPORTED THAT, AT THE START OF A NAVIO ASSISTED TKA SURGERY, IT WAS DISCOVERED THAT THE NAVIO BONE SCREW DRIVER WAS THREADED AND NOT HOLDING THE PINS. 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 12584090 ↗