NA 319.04Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10886982189974), received between Apr 3, 2017 and Dec 31, 2025 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 31, 2025Device-Device Incompatibility; Material Deformation; Material Twisted/Bent; Device-Device Incompatibility; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED ON (B)(6) 2025, THE DEPTH GAUGE WAS DISCOVERED TO BE TWISTED AND DEFORMED; THE TIP WOULDN¿T COME OUT OF IT. THE EVENT DID NOT OCCURRED DURING STERILE PROCESSING OR FIELD INSPECTION. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23934929 ↗
• MalfunctionJun 25, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, A DEPTH GAUGE FOR LOCKING SMALL FRAG WAS BROKEN. IT WAS EITHER INTRA OR POST OP THROUGH DECONTAMINATION PROCESS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22331325 ↗
• MalfunctionJun 4, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE DEPTH GAUGE WAS BROKEN. THIS REPORT INVOLVES ONE (1) DEPTH GAUGE FOR 2.7MM & SMALL SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19459472 ↗
• MalfunctionMar 11, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024 , THE DEPTH GAUGE WAS BROKEN. NO PATIENT CONSEQUENCE WAS REPORTED. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 2.7MM & SMALL SCREWS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18873943 ↗
• MalfunctionOct 30, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6), 2023 THE DRILL GUIDE BROKE . IT IS UNKNOWN WHEN THE ISSUE WAS DISCOVERED. THERE WERE NO PATIENT OUTCOMES OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 2.7MM & SMALL SCREWS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18028624 ↗
• MalfunctionMay 11, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING ROUTINE MEDICAL DEVICE REPROCESSING ON (B)(6) 2023, STAFF INDICATED THAT THE LONG METAL HOOK ON THE DEPTH GAUGE HAD BROKEN OFF FROM ITS BASE. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE DEPTH GAUGE FOR 2.7MM & SMALL SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16911027 ↗
• MalfunctionJun 28, 2022Mechanical Jam; Mechanical Jam

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON UNKNOWN DATE, THE HOOK OF THE DEPTH GAUGE WAS NOT MOVING FREELY. HOOK NEEDS TO BE ASSESSED. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE DEPTH GAUGE FOR 2.7MM & SMALL SCREWS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14840741 ↗
• MalfunctionJun 7, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEM TIP WAS FOUND BROKEN. THERE WAS NO PATIENT OUTCOME/CONSEQUENCES. IT IS UNKNOWN WHEN THE ISSUE WAS OBSERVED. IT IS UNKNOWN IF THERE IS PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE DEPTH GAUGE FOR 2.7MM & SMALL SCREWS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14622193 ↗
• MalfunctionFeb 23, 2022Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, ONE (1) PELVIC REDUCTION FORCEP, ONE (1) LISS INSERTION GUIDE FOR DISTAL FEMUR, ONE (1) DEPTH GAUGE FOR LOCKING SCREW, FOUR (4) UNIVERSAL CHUCK WITH T-HANDLE, ONE (1) CANNULATED 4.0MM HEXAGONAL SCREWDRIVER, ONE (1) PELVIC REDUCTION FORCEP, TWO (2) RIA DRIVE SHAFT, ONE (1) BENDING PLIERS, ONE (1) FORCEP FOR BROKEN SCREW REMOVAL, ONE (1) LOCKING PLIER, TWO (2) LARGE QUICK COUPLING, ONE (1) DEPTH GAUGE, ONE (1) SILICONE HANDLE, ONE (1) RED FORCEPS SERRATED JAW RATCHET, ONE (1) PLATE HOLDING FORCEP, ONE (1) REDUCTION FORCEP WITH POINT RATCHET, ONE (1) HOLDING SLEEVE WITH WING SCREW, ONE (1) GRAPHIC CASE AND TWO (2) GRAPHIC CASE FOR SCREW REMOVAL SET WERE BROKEN FROM USAGE. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) DEPTH GAUGE FOR 2.7MM & SMALL SCREWS. THIS IS REPORT 11 OF 16 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13584838 ↗
• MalfunctionFeb 18, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE BROWN COMPOSITE HANDLES OF THE SMALL HEX SCREWDRIVERS ARE DEGRADING, LEAVING BROWN STAINS AND MARKS ON STERILIZATION CONTAINERS AND SOME HAVE EVEN BEGUN TO CHIP. HOOKS ON DEPTH GAUGES SEEM WORN CAUSING DIFFICULTY MEASURING SCREW LENGTHS. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) DEPTH GAUGE FOR 2.7MM & SMALL SCREWS. THIS IS REPORT 7 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13563155 ↗
• MalfunctionFeb 18, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE BROWN COMPOSITE HANDLES OF THE SMALL HEX SCREWDRIVERS ARE DEGRADING, LEAVING BROWN STAINS AND MARKS ON STERILIZATION CONTAINERS AND SOME HAVE EVEN BEGUN TO CHIP. HOOKS ON DEPTH GAUGES SEEM WORN CAUSING DIFFICULTY MEASURING SCREW LENGTHS. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) DEPTH GAUGE FOR 2.7MM & SMALL SCREWS. THIS IS REPORT 5 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13562358 ↗
• MalfunctionFeb 18, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE BROWN COMPOSITE HANDLES OF THE SMALL HEX SCREWDRIVERS ARE DEGRADING, LEAVING BROWN STAINS AND MARKS ON STERILIZATION CONTAINERS AND SOME HAVE EVEN BEGUN TO CHIP. HOOKS ON DEPTH GAUGES SEEM WORN CAUSING DIFFICULTY MEASURING SCREW LENGTHS. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) DEPTH GAUGE FOR 2.7MM & SMALL SCREWS. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13562195 ↗
• MalfunctionFeb 18, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE BROWN COMPOSITE HANDLES OF THE SMALL HEX SCREWDRIVERS ARE DEGRADING, LEAVING BROWN STAINS AND MARKS ON STERILIZATION CONTAINERS AND SOME HAVE EVEN BEGUN TO CHIP. HOOKS ON DEPTH GAUGES SEEM WORN CAUSING DIFFICULTY MEASURING SCREW LENGTHS. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) DEPTH GAUGE FOR 2.7MM & SMALL SCREWS. THIS IS REPORT 2 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13562164 ↗
• MalfunctionJan 7, 2022Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, PRODUCTS FOUND BROKEN AFTER SURGERY AND ARE BEYOND REPAIR. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES EIGHTEEN (18) DEVICES. THIS REPORT IS FOR (1) DEPTH GAUGE FOR 2.7MM & SMALL SCREWS THIS REPORT IS 11 OF 14 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13196841 ↗
• MalfunctionOct 26, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PIN SNAPPED OFF THE DEPTH GAUGE. IT IS UNKNOWN WHERE THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE IS PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 2.7MM & SMALL SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12697565 ↗
• MalfunctionJun 8, 2021Break; Break

  IT WAS REPORTED THAT, DURING A PROCEDURE IT WAS NOTED THE DEPTH GAUGE WAS BROKEN WHERE THE SHAFT MEETS THE NUMBERED BARREL ON THE INSIDE CLAM SHELL BONE CLAMP WITH SPEED LOCK. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 2.7MM & SMALL SCREWS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11957315 ↗
• MalfunctionJun 2, 2021Material Deformation; Mechanical Jam; Material Deformation; Mechanical Jam

  IT WAS REPORTED ON (B)(6) 2021 DURING A WRIST FUSION PROCEDURE, WHILE USING A DEPTH GAUGE, THE SURGEON COMPLAINED THAT THE DEPTH GAUGE WAS NOT PERFORMING WELL AND STICKING. THE TIP ALSO SEEMED TO BE BENT. THERE WAS NO SURGICAL DELAY. THE SURGERY WAS ABLE TO BE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 2.7MM & SMALL SCREWS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11921743 ↗
• MalfunctionSep 17, 2020Incorrect Measurement; Material Deformation; Incorrect Measurement; Material Deformation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2020, THE TIP OF THE DEPTH GAUGE FOR 2.7MM & SMALL SCREWS WAS BENT. THE SURGERY WAS PERFORMED BUT HAD TO BE REDONE BECAUSE THEY PUT IN THE WRONG SCREWS DUE TO THE DEPTH GAUGE READING THE WRONG INFORMATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE USE OF ANOTHER DEPTH GAUGE. THERE WAS AN UNKNOWN NUMBER OF MINUTES OF SURGICAL DELAY REPORTED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 2) THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 2.7MM & SMALL SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10551372 ↗
• MalfunctionMar 19, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON FEBRUARY 19, 2020, THE DEPTH GAUGE TIP BROKE OFF THE SHAFT OF THE MEASURING DEVICE DURING AN ORIF OF AN ANKLE. NO SURGICAL DELAY REPORTED. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 2.7MM & SMALL SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9855758 ↗
• MalfunctionOct 18, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SLENDER METAL EXTENSION OF A DEPTH GAUGE THAT GOES DOWN INTO THE DRILL HOLE IS BREAKING OFF THE HANDLE. IT WAS DISCOVERED DURING CLEANUP. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT MEDICAL PRODUCT: UNKNOWN HANDLE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9209904 ↗
• MalfunctionApr 5, 2019Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIP OF THE DEPTH GAUGE FOR SCREWS WAS BROKEN OFF IN THE WASHING CYCLE IN THE MEDICAL DEVICE REPROCESSING DEPARTMENT (MDRD). THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT. THIS REPORT IS FOR A DEPTH GAUGE FOR 2.7MM & SMALL SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8486457 ↗
• MalfunctionOct 31, 2018Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN (B)(6) 2018, THE DEPTH GAUGE WAS FOUND BROKEN BY MEDICAL DEVICE REPROCESSING DEPARTMENT (MDRD). THE SILVER HOOK APPEARS TO BE UNTHREADED FROM THE BLACK PIECE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 2.7MM & SMALL SCREWS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8026058 ↗
• MalfunctionOct 8, 2018Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, DURING AN UNKNOWN PROCEDURE, THE DEPTH GAUGE NEEDLE BROKE AT THE BASE WHILE MEASURING A SCREW HOLE. THE SURGEON USED ANOTHER DEPTH GAUGE FROM ANOTHER SET TO COMPLETE THE PROCEDURE. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 2.7MM & SMALL SCREWS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7944957 ↗
• MalfunctionApr 3, 2017Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED ON (B)(6) 2017 THAT THE HOSPITAL¿S TECHNICIAN FROM CENTRAL SERIAL PROCESSING DEPARTMENT HAD TWO (2) BROKEN INSTRUMENTS THAT CAME DOWN FROM THE OPERATING ROOM. THE BENDING PLIERS WERE BROKEN INTO TWO PIECES AT THE INSTRUMENT HINGE AND THE DEPTH GAUGE IS REPORTED AS BROKEN AT THE DISTAL TIP. NO ADDITIONAL INFORMATION WAS GIVEN FROM THE HOSPITAL, AND NOTHING ELSE IS FORTHCOMING. THERE WAS NO REPORTED PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT; HOWEVER, IT IS UNKNOWN WHEN THE REPORTED DEVICE WERE BROKEN. THE REPORTED ISSUES WERE DISCOVERED DURING INSTRUMENT INSPECTION. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6453632 ↗