R3 71364451Recalls & reported problems

Summary

The FDA's MAUDE database contains 145 adverse event reports that list this exact device (DI 03596010599438), received between Feb 5, 2019 and Jul 15, 2026 — classified as 22 injuries, 123 malfunctions.

The most frequently reported specific device problem is “Break” (89 reports).

1 other recall cover devices cleared under the same FDA submission (K093047); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 145 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25825715 ↗
• MalfunctionJun 12, 2026Break

  IT WAS REPORTED THAT, DURING A THA, ONE (1) R3 DEPTH GAUGE BROKE. THE PROCEDURE WAS FINISHED USING A EQUIVALENT S+N BACKUP PRODUCT WITHOUT ANY SURGICAL DELAY. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25494363 ↗
• MalfunctionJun 2, 2026Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) R3 DEPTH GAUGE BROKE. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25363886 ↗
• MalfunctionMar 12, 2026Fracture

  IT WAS REPORTED THAT, DURING A THR, ONE (1) R3 DEPTH GAUGE BROKE INTO TWO PIECES WHEN SURGEON PRESSED THE END ONTO THE ACETABULUM BONE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24581595 ↗
• MalfunctionJan 12, 2026Fracture

  IT WAS REPORTED THAT, DURING A THA SURGERY, THE TIP OF ONE (1) R3 DEPTH GAUGE BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24036597 ↗
• MalfunctionJan 6, 2026Fracture

  IT WAS REPORTED THAT DURING A THA SURGERY, THE R3 DEPTH GAUGE BROKE WHILE USING IT. THE END WAS RETRIEVED WITH VANDERBILT FORCEPS. ALL PIECES WERE RETRIEVED AND ACCOUNTED FOR. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK- UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23974323 ↗
• MalfunctionNov 17, 2025Break; Break

  IT WAS REPORTED THAT DURING A THA SURGERY, THE R3 DEPTH GAUCE BROKE; THE PROCEDURE WAS PERFORMED WITHOUT ANY SURGICAL DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23566774 ↗
• MalfunctionSep 8, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, ONE (1) R3 DEPTH GAUGE BROKE. ALL THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT WITH TWEEZERS. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22993148 ↗
• MalfunctionJul 28, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) R3 DEPTH GAUGE SNAPPED IN HALF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22633111 ↗
• MalfunctionJul 24, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, ONE (1) R3 DEPTH GAUGE BROKE IN HALF. IT IS UNKNOWN HOW PROCEDURE WAS COMPLETED OR IF THERE WAS A SURGICAL DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22603511 ↗
• MalfunctionJul 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, THE TIP OF ONE (1) R3 DEPTH GAUGE SNAPPED DURING STANDARD USAGE. NO PIECES FELL INSIDE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22565259 ↗
• MalfunctionJul 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR, ONE (1) R3 DEPTH GAUGE BROKE WHEN IT WAS REMOVED. NO PIECES FELL INSIDE THE WOUND. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22391767 ↗
• MalfunctionJun 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, ONE (1) R3 DEPTH GAUGE BROKE OFF AFTER SURGEON SIZED FOR SCREW. ALL PIECES RETRIEVED BY HAND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22124884 ↗
• MalfunctionMay 28, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY ONE (1) R3 DEPTH GAUGE BROKE WHILE SIZING FOR SCREW. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22096638 ↗
• MalfunctionMay 26, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE R3 DEPTH GAUGE BROKE IN HALF WHEN TRYING TO MEASURE SCREW LENGTH THROUGH THE CUP. ALL PIECES WERE REMOVED AND ACCOUNTED USING A FORCEPS. IT IS UNKNOWN HOW THE SURGERY WAS COMPLETED OR IF THIS CAUSED A SURGICAL DELAY. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22084619 ↗
• MalfunctionApr 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR, WHILE TRIALING SCREW SIZE THE R3 DEPTH GAUGE, BROKE OFF. ALL PIECES WERE RETRIEVED BY HAND. NOTHING WAS LEFT IN THE PATIENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21880116 ↗
• MalfunctionApr 20, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, WHILE TRIALING FOR SCREW SIZE, ONE (1) R3 DEPTH GAUGE SNAPPED IN HALF. NOTHING LEFT IN PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21870330 ↗
• MalfunctionDec 27, 2024Break; Break

  IT WAS REPORTED THAT, DURING A THR, A (1) R3 DEPTH GAUGE BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21026258 ↗
• MalfunctionDec 6, 2024Degraded; Fracture; Degraded; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, WHILE MEASURING DEPTH FOR SCREW, ONE (1) R3 DEPTH GAUGE BROKE. NOTHING WAS LEFT IN THE PATIENT AND THERE WERE NO OTHER ISSUES TO NOTE. THE BROKEN PART WAS GRABBED WITH FORCEPS AND THERE WAS NO EXTRA TISSUE, OR ANYTHING NEEDED TO BE REMOVED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20861047 ↗
• MalfunctionDec 4, 2024Break; Break

  IT WAS REPORTED THAT, DURING THR SURGERY, A R3 DEPTH GAUGE BROKE WHILE BEING USED TO MEASURE A SCREW. THE PROCEDURE WAS RESUMED, WITHOUT ANY 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 20844474 ↗
• MalfunctionNov 13, 2024Break; Break

  IT WAS REPORTED THAT, DURING THR SURGERY, ONE (1) R3 DEPTH GAUGE BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20678757 ↗
• MalfunctionNov 11, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR, ONE (1) R3 DEPTH GAUGE BROKE WHILE MEASURING FOR SCREW LENGTH. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20652673 ↗
• MalfunctionOct 9, 2024Break; Fracture; Material Deformation; Break; Fracture; Material Deformation

  IT WAS REPORTED THAT DURING A THR SURGERY, ONE (1) R3 DEPTH GAUGE BROKE. THE PROCEDURE RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20409521 ↗
• MalfunctionOct 9, 2024Break; Break

  IT WAS REPORTED THAT DURING A THR SURGERY, THE R3 DEPTH GAUGE BROKE. THE PROCEDURE WAS PERFORMED, AFTER NO 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 20409368 ↗
• MalfunctionOct 1, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE R3 DEPTH GAUGE BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, IT IS UNKNOWN HOW. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20344230 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093047. One submission often covers many models, so check the product and lot details in each record.

• Z-0245-2022 · Jun 17, 2021 · Open, Classified
  Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434