JOURNEY II UNI 74016422Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00885556692240), received between Jul 14, 2020 and Nov 3, 2025 — classified as 3 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A PARTIAL KNEE REPLACEMENT SURGERY, THE METAL PIECE OF ONE (1) 3.5MM LOCKING HEX T-HANDLE BROKE OFF INSIDE THE LOCKING HOLE OF THE LM/RL TIBIA RESECTION GUIDE STANDARD. THE PROCEDURE WAS COMPLETED WITH ANY DELAY, USING A SIMILAR S+N BACK UP PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23460456 ↗
• MalfunctionOct 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN UNICONDYLAR KNEE REPLACEMENT SURGERY WHILE TRYING TO UNLOCK ONE (1) RM/LL TIBIA RESECTION GUIDE STANDARD TO ADJUST THE CUT DEPTH, ONE (1) 3.5MM LOCKING HEX T HANDLE BROKE INSIDE THE LOCKING SYSTEM OF THE CUT BLOCK. THE PIECE THAT BROKE OFF REMAINED INSIDE THE TIBIAL CUT BLOCK. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23216025 ↗
• MalfunctionApr 15, 2025Break; Fracture; Detachment of Device or Device Component; Break; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING UKR SURGERY, ONE (1) 3.5MM LOCKING HEX T-HANDLE BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY SURGICAL DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21845743 ↗
• MalfunctionMar 26, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN UKA SURGERY, THE SCREW OF ONE (1) RM/LL TIBIA RESECTION GUIDE STANDARD COULD NO LONGER BE ADJUSTED, AND MORE FORCE WAS APPLIED CAUSING ONE (1) 3.5MM LOCKING HEX T-HANDLE TO BREAK. NO PARTS FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED WITHOUT DELAY USING THE SAME DEVICES, AND NO INJURIES WERE REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21702228 ↗
• MalfunctionOct 22, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A UKR SURGERY, THE 3.5MM LOCKING HEX T-HANDLE TIP BROKE OFF. THE PATIENT IS FINE AND ALL PARTS WERE RETRIEVED. IT IS UNKNOWN HOW WAS COMPLETED THE SURGERY. NO DELAY OR INJURY TO PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20501886 ↗
• MalfunctionOct 13, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A UKA, THE TIP OF A 3.5MM LOCKING HEX T-HANDLE BROKE. NO PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20436188 ↗
• MalfunctionJul 23, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN UNICONDYLAR KNEE REPLACEMENT SURGERY, THE TIP OF AN SCREW OF THE 3.5MM LOCKING HEX T-HANDLE FRACTURED. NO PIECES FELL INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A SMITH + NEPHEW BACK UP DEVICE PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19806792 ↗
• MalfunctionMay 6, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A UKA SURGERY, WHEN ADJUSTING THE RM/LL TIBIA RESECTION GUIDE, THE TIP OF THE 3.5MM LOCKING HEX T-HANDLE BROKE OFF AT THE FRONT. ALL THE BROKEN PIECES WERE REMOVED WITH SUCTION. NOTHING REMAINED IN THE PATIENT. THERE WAS NO SURGICAL DELAY AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19247869 ↗
• MalfunctionJan 26, 2024Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE 3.5MM LOCKING HEX T-HANDLE BROKE DURING PLACEMENT OF THE FEMORAL CUT GUIDE; THE TIP OF THE DEVICE FRACTURED AND AN INNER ROD BECAME BENT. THE BROKEN PIECES WERE ALL RECOVERED. THE PROCEDURE WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, USING A BACKUP SET. NO PATIENT INJURY WAS REPORTED DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18591715 ↗
• MalfunctionNov 30, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE TIP OF ONE (1) 3.5MM LOCKING HEX T-HANDLE BROKE OFF, ALL PIECES WERE RECOVERED AND ACCOUNTED, IT WAS REMOVED WITH FORCEPS. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, CHANGING THE SURGICAL TECHNIQUE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18239251 ↗
• MalfunctionJun 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, A 3.5MM LOCKING HEX T-HANDLE TIP BROKE IN PIECES. IT WAS USED ON THE EXTRAMEDULLARY TIBIA GUIDE WHILE ON THE PATIENT, HOWEVER, NO DEBRIS WENT INTO THE WOUND. THE BROKEN PIECES WERE REMOVED FROM THE STERILE FIELD. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17122036 ↗
• MalfunctionJun 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA THE 3.5MM LOCKING HEX T-HANDLE TIP BROKE IN PIECES. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17122031 ↗
• MalfunctionMay 29, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGERY THE TIP OF THE 3.5MM LOCKING HEX T-HANDLE BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. ALL PIECES WERE REMOVED. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17017240 ↗
• MalfunctionMay 2, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE TIP OF ONE (1) 3.5MM LOCKING HEX T-HANDLE BROKE OFF DURING THE SURGERY. NO PIECE FELL INTO THE ANATOMY. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16857691 ↗
• MalfunctionMar 14, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING TKA SURGERY, THE TIP OF THE 3.5MM LOCKING HEX T-HANDLE BROKE TRYING TO LOOSE RESECTION GUIDE SCREW. SURGERY WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, WITH S+N BACK-UP DEVICES. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16542370 ↗
• MalfunctionMar 6, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING SURGERY, THE TIP OF (1) 3.5MM LOCKING HEX T-HANDLE, BROKE OFF. PIECES WERE ALL RETRIEVED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16491406 ↗
• MalfunctionSep 30, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF A 3.5MM LOCKING HEX T-HANDLE BROKE OFF. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15519024 ↗
• MalfunctionAug 10, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE TIP ON A 3.5MM LOCKING HEX T-HANDLE IS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15204007 ↗
• MalfunctionJul 23, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, THE 3.5MM LOCKING HEX T-HANDLE TIP BROKE. IT IS UNKNOWN HOW SURGERY WAS FINISHED AND IF THERE WAS ANY DELAY. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15090395 ↗
• MalfunctionJul 23, 2022Break; Break

  IT WAS REPORTED THAT, DURING A UKR (NAVIO) SURGERY, A 3.5MM LOCKING HEX T-HANDLE DOES NOT LOCK ONTO CUTTING BLOCK. SURGERY WAS FINISHED WITH THE SAME DEVICE, WITHOUT ANY DELAY. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED. PRELIMINARY RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THE DEVICE WAS FOUND TO HAVE THE TIP BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15090368 ↗
• MalfunctionJun 28, 2022Break; Break

  IT WAS REPORTED THAT THE TIP OF A 3.5MM LOCKING HEX T-HANDLE IS BROKEN. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14847856 ↗
• InjuryJun 11, 2022Break; Break

  IT WAS REPORTED THAT, DURING A UNICOMPARTMENTAL KNEE REPLACEMENT SURGERY, WHEN ADJUSTING THE CUTTING AMOUNT AND ATTEMPTING TO LOCK, THE TIP OF THE 3.5MM LOCKING HEX T-HANDLE BROKE ALL THE BROKEN PIECES WERE REMOVED. SURGERY WAS RESUMED, WITHOUT ANY SURGICAL DELAY, WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14670209 ↗
• InjuryApr 25, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING TOTAL KNEE ARTHROPLASTY, THE TIP OF A 3.5MM LOCKING HEX T-HANDLE SHEARED OFF UNDER TENSION INSIDE THE PATIENT. ALL PIECES WERE RECOVERED. SURGERY WAS RESUMED AFTER A NON-SIGNIFICANT DELAY. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14192039 ↗
• MalfunctionMar 8, 2022Break; Break

  IT WAS REPORTED THAT THE TIP OF THE 3.5MM LOCKING HEX T-HANDLE IS BROKEN AND WOULD NOT INSERT. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13697433 ↗
• MalfunctionNov 24, 2021Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, A 3.5MM LOCKING HEX T-HANDLE BROKE. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12869524 ↗