NA 03.111.005Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 10886982072078), received between Jan 30, 2019 and Jun 22, 2026 — classified as 54 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (22 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE SCREWDRIVER STRIPPED STAR. ANOTHER SCREWDRIVER SHAFT TIPS ARE TORQUED/DAMAGED. THE DEPTH GAUGE WON'T SLIDE. NO OPERATION INVOLVED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25579277 ↗
• MalfunctionJan 26, 2026Mechanical Jam

  IT WAS REPORTED THAT ON (B)(6) 2025, SURGEON COMPLAINED OF DEPTH GAUGE BEING STUCK. IT WAS CONFIRMED DURING POST OP INSPECTION. THERE WAS NO DELAY IN CASE AND NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24183677 ↗
• MalfunctionJan 23, 2026Device-Device Incompatibility

  IT WAS REPORTED ON 12TH DECEMBER, 2025 THAT DEPTH GAUGE DOES NOT HOOK. NO, PATIENT CONSEQUENCES. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160689 ↗
• MalfunctionJan 15, 2026Break

  IT WAS REPORTED THAT THE TIP OF THE DEPTH GAUGE BROKE OFF. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24085835 ↗
• MalfunctionAug 5, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT ORIF SURGERY WITH THE DEPTH GAUGE. THE AGENCY REPORTED TO THE SALES REP THAT THE DEPTH GAUGE WAS EXTREMELY STIFF DURING THE SURGERY AND DIFFICULT TO USE. AFTER CLEANING, THIS IMPROVED SLIGHTLY, BUT IT WAS STILL QUITE STIFF COMPARED TO THE PRODUCT THEY HAD USED PREVIOUSLY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22720294 ↗
• MalfunctionAug 1, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT TWO DEPTH GAUGE ITEM NUMBER 03.111.005 WERE BENT. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22686559 ↗
• MalfunctionAug 1, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT TWO DEPTH GAUGE ITEM NUMBER 03.111.005 WERE BENT. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22686542 ↗
• MalfunctionJul 24, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT ON (B)(6) 2025, THE SLIDER IS STICKING. THERE WAS NO OPERATION INVOLVED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22588786 ↗
• MalfunctionJul 18, 2025Break; Break

  IT WAS REPORTED THAT THE DEPTH GAUGE BROKE BEFORE STARTING A DISTAL RADIUS CASE. SCRUB TECH WAS PUTTING IT TOGETHER AND THE TIP BROKE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22545927 ↗
• MalfunctionJun 26, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE DEPTH GAUGE IS STICKY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338533 ↗
• MalfunctionJun 13, 2025Break; Break

  IT WAS REPORTED THAT THE DEPTH GAUGE TIPS BROKE OFF. NO OPERATION WAS NEEDED. THERE WAS NO PATIENT CONSEQUENCES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22207926 ↗
• MalfunctionJun 9, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT ON MAY 15, 2025, THE DEVICE DID NOT SLIDE WELL. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22169280 ↗
• MalfunctionMay 28, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE DEPTH GAUGE IS STICKY AND CUSTOMER IS ASKING FOR REPLACEMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22094682 ↗
• MalfunctionMay 28, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE DEPTH GAUGE IS STICKY AND CUSTOMER IS ASKING FOR REPLACEMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22094649 ↗
• MalfunctionMay 28, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE DEPTH GAUGE IS STICKY AND CUSTOMER IS ASKING FOR REPLACEMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22094615 ↗
• MalfunctionMay 1, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025. THE DEPTH GAUGES ARE STUCK AND DON'T MOVE ANYMORE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21944141 ↗
• MalfunctionMay 1, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025. THE DEPTH GAUGES ARE STUCK AND DON'T MOVE ANYMORE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21943993 ↗
• MalfunctionApr 24, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE DEPTH GAUGE WAS BENT. IT WAS DISCOVERED DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21902632 ↗
• MalfunctionApr 3, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE DEVICE WAS NOT SLIDING PROPERLY. THERE WAS NO OPERATION AND NO PATIENT INVOLVED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21764492 ↗
• MalfunctionJan 22, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEPTH GAUGE WAS BENT TO A DEGREE AND IS NOT USABLE. IT WAS NO LONGER FUNCTIONAL AND IN NEED OF REPLACEMENT. THE ISSUE WAS IDENTIFIED DURING PRE-OP TESTING OF THE EQUIPMENT AND DID NOT IMPACT PATIENT OUTCOMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21210171 ↗
• MalfunctionSep 20, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2024, THE MEASURING DEVICE WAS CROOKED AND UNUSABLE. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20267058 ↗
• MalfunctionSep 13, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT ON AUGUST 29,2024 THE T8 SHORT DRIVERS DID NOT RETAIN SCREWS DUE TO TIPS BEING WORN AND DEPTH GAUGE GETTING STUCK AND NOT FUNCTIONING PROPERLY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) DEPTH GAUGE FOR 2.0/2.4 AND 2.7 SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20214654 ↗
• MalfunctionSep 10, 2024Break; Device Slipped; Break; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2024 THE BALL IS LOOSE. BROKEN. IT WAS DISCOVERED DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 2.0/2.4 AND 2.7 SCREWS. THIS IS REPORT 3 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20185847 ↗
• MalfunctionSep 3, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE DEVICE WAS RECEIVED AS BLIND UNIT, HOWEVER, IT COULDN¿T BE ASSOCIATED WITH A COMPLAINT OR ANY OTHER EXISTING RECORD. DURING MANUFACTURER'S PRELIMINARY INVESTIGATION OF THE RETURNED DEVICE ON AUGUST 8, 2024. IT WAS DISCOVERED THAT THE DEVICE WAS BENT FROM THE NEEDLE. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 2.0MM/2.4MM AND 2.7MM SCREWS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20126121 ↗
• MalfunctionJul 1, 2024Incorrect Measurement; Material Deformation; Incorrect Measurement; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING POSTOPERATIVE INSPECTION OF THE SET, IT WAS NOTED THAT THE 2 DEPTH GAUGES WERE INOPERABLE. ONE DEPTH GAUGES WAS UNABLE TO SLIDE. THE SECOND DEPTH PROBE WAS EXTREMELY BENT AND THERE WERE CONCERNS FOR INCORRECT MEASUREMENTS. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) DEPTH GAUGE FOR 2.0MM/2.4MM AND 2.7MM SCREWS. THIS IS REPORT 2 OF 2 FOR (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19642464 ↗