NA 03.130.250Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 10886982075420), received between May 1, 2017 and Sep 23, 2026 — classified as 45 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Material Deformation

  It was reported the Depth Gauge has a kink in it and no longer works. The procedure was completed with an unknown delay and no patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872187 ↗
• MalfunctionSep 8, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50674105 ↗
• MalfunctionAug 27, 2026Material Deformation

  It was reported that the tip of the depth is bent.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50478236 ↗
• MalfunctionMay 1, 2026Material Deformation

  IT WAS REPORTED THAT DEPTH GAUGE F/SCR Ø1.3 - 2 MEAS-RANGE AND DEPTH GAUGE F/SCR Ø2+2.4 MEAS-RANGE UP-T EXPERIENCED FAILURES. THE EVENT INVOLVED THE TIPS BREAKING OFF TWO DEPTH GAUGES AND A THIRD BEING SEVERELY BENT WHILE ATTEMPTING TO FIND THE FAR HOLE DURING A CASE. THE DEVICES WERE SEPARATED INTO TWO OR MORE PIECES, AND THE EVENT WAS IDENTIFIED AS INVOLVING NO PATIENT OR USER IMPACT, WITH NO OBSERVABLE CLINICAL SYMPTOMS OR CHANGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25056363 ↗
• MalfunctionJan 8, 2026Material Deformation

  IT WAS REPORTED THAT THE DEPTH GAUGE HAD A BENT TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24002516 ↗
• MalfunctionDec 15, 2025Break; Break

  THIS DEVICE IS BROKEN WITHOUT CONSEQUENCE FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23802410 ↗
• MalfunctionOct 22, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE DISTAL END OF THE 1.3MM/1.5MM DEPTH GAUGE WAS BENT AND WAS ASKED TO BE REPLACED BY THE SURGEON. THERE WAS NO DELAY IN SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23359615 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, SURGEON NEEDED TO USE THE VARIABLE ANGLE HAND TRAY FOR A METACARPAL FIXATION CASE. DEPTH GAUGE BROKE WHEN SCRUB TECH WAS CHECKING IT. HAD TO CHANGE PLANS AND USE A DIFFERENT PLATE AND USE A DIFFERENT DEPTH GAUGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23292522 ↗
• MalfunctionSep 10, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2025, A DEPTH GAUGE WAS BENT AND SURGEON WAS UNABLE TO BEND IT BACK. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23019928 ↗
• MalfunctionSep 2, 2025Break; Break

  IT WAS REPORTED THAT THE DEPTH GAUGE WAS BROKEN. IT WAS NOTICED DURING A CASE AND PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22938525 ↗
• MalfunctionAug 29, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DEPTH GAUGE TIPS SEVERELY BENT. NO SURGICAL DELAY WAS REPORTED. NO PATIENT HARM WAS THERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22921294 ↗
• MalfunctionAug 27, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DEPTH GAUGE TIPS SEVERELY BENT. NO SURGICAL DELAY WAS REPORTED. NO PATIENT HARM WAS THERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22902344 ↗
• MalfunctionJun 17, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2025, THERE WERE DEVICE MALFUNCTIONS.; KNOB BROKE, BENT ROD, STRIPPED ROD. IT IS UNKNOWN WHERE EVENT OCCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22238205 ↗
• MalfunctionJun 13, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THE TIP PART OF THE DEPTH GAUGE IS BENT. ISSUE IS UNREPAIRABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22205774 ↗
• MalfunctionJun 3, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE NEEDLE ON THE BLACK DEPTH GAUGE HAS BEEN BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22133410 ↗
• MalfunctionJan 29, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE INSTRUMENT WAS TOO BENT TO BE USED. THESE ISSUES WERE IDENTIFIED DURING PRE-OP TESTING OF THE EQUIPMENT AND DID NOT IMPACT PATIENT OUTCOMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21266426 ↗
• MalfunctionOct 4, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS NOTICED THE ITEMS WERE BENT AT THE START OF THE SURGERY. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20371241 ↗
• MalfunctionAug 15, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2024 THE ARM HAD GOTTEN BENT WHILE INSTALLING THE TWO PIECES AFTER CLEANING. THERE WAS NO PATIENT OUTCOME REPORTED. THIS REPORT INVOLVES ONE (1) DEPTH GAUGE FOR 1.3MM/1.5MM AND 2.0MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19992862 ↗
• MalfunctionMay 1, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CLAMP WOULDN'T STAY CLOSED, AND THE DEPTH GAUGE WAS BENT. THE EVENT OCCURRED DURING STERILE PROCESSING AND FIELD INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE DEPTH GAUGE FOR 1.3MM/1.5MM AND 2.0MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19224076 ↗
• MalfunctionFeb 12, 2024Break; Break

  IT WAS REPORTED THAT ON JAN 31, 2024, THE HOOK OF THE DEVICE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 1.3/1.5 AND 2.0 SCREWS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18691230 ↗
• MalfunctionDec 14, 2023Mechanical Jam; Mechanical Jam

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN NEW ZEALAND AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE SURGEON WAS USING THE VA HAND SET CONSIGNED TO THE HOSPITAL, THE SCREW COULD NOT BE MEASURED BECAUSE THE DEPTH GAUGE WAS JAMMED. ANOTHER DEPTH GAUGE FROM A DIFFERENT SET WAS USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) DEPTH GAUGE FOR 1.3MM/1.5MM AND 2.0MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18327318 ↗
• MalfunctionNov 28, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2023, WHILE INSPECTING THE INSTRUMENTATION, AFTER GOING THROUGH THE DECONTAMINATION PROCESS, SALES REP NOTICED THAT THERE WERE SEVERAL INSTRUMENTS THAT WERE DAMAGED. THERE WILL BE A TOTAL OF EIGHT PRODUCTS ON THIS COMPLAINT. THERE WAS A 5 MM FLEXIBLE SCREWDRIVER, AND THE TIP OF THE SCREWDRIVER IS BROKE OFF. THERE WAS A 17 MM FLEXIBLE MONOBLOC REAMER, AND THIS ITEM APPEARS TO BE TWISTED IN A MANNER THAT HAS HAD SEVERE TORQUE APPLIED TO IT. THERE WAS THE SELF RETAINING PIN FOR THE POWER SCREWDRIVER. THE TIP OF IT HAS THREADS ON IT, AND THE THREADS WERE BROKE OFF. THERE WAS A 2.5 MM SCREWDRIVER, AND THE TIP OF THE SCREWDRIVER WAS STRIPPED. THERE WAS A 2.8 MM DRILL GUIDE, AND THE THREADS ON IT WERE STRIPPED. THERE WAS A HANDLE FOR THE 2.8 MM DRILL GUIDE AND THE INNER THREADS ON THIS HANDLE ARE STRIPPED. THE TIP OF THE DEPTH GAUGE IS BROKE OFF. THERE WAS ANOTHER DEBT GAUGE IN THE TIP OF THE DEPTH GAUGE IS BENT. ALL OF THESE ITEMS WERE SC STOCK AND BELONG IN FIELD INVENTORY SETS. ALL OF THESE ITEMS NEEDED TO BE REPLACED SO THAT THE FIELD INVENTORY SETS WOULD BE FULL. THERE WAS NO PATIENT INVOLVEMENT IN ANY OF THESE ITEMS. ALL ITEMS WERE ALSO AVAILABLE TO BE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18221427 ↗
• MalfunctionAug 22, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2023, THE DEPTH GAUGE WAS BENT AND NOT FUNCTIONAL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO PATIENT CONSEQUENCE WAS REPORTED. THIS REPORT INVOLVES ONE DEPTH GAUGE FOR 1.3MM/1.5MM AND 2.0MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17595993 ↗
• MalfunctionMar 22, 2023Break; Material Deformation; Break; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE DEPTH GAUGE IN QUESTION WAS DEFORMED WHEN THE DISTRIBUTOR INSPECTED BEFORE DELIVERY TO HOSPITAL. THE DISTRIBUTOR INQUIRED WHETHER THE DEVICE APPEARED TO HAVE BEEN BENT INTENTIONALLY AND WHETHER IT WOULD PASS YOUR INSPECTION STANDARDS. THE DELIVERY WAS MADE IN THE DEFORMED STATE BECAUSE CLOSING TIME FOR DELIVERY TO THE HOSPITAL WAS APPROACHING. DURING CLEANSING IN THE OPERATION ROOM, THE TIP OF THE DEPTH GAUGE WAS BROKEN OFF. A DIFFERENT STANDARD DEPTH GAUGE WILL BE USED FOR SURGERY. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 1.3MM/1.5MM AND 2.0MM SCREWS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16590947 ↗
• MalfunctionMar 9, 2023Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING REPROCESSING DEPTH GAUGE WAS BENT. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 1.3MM/1.5MM AND 2.0MM SCREWS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16513091 ↗