NA SD319.002Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10886982004925), received between Jul 26, 2019 and Jul 11, 2025 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2025Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT TIP BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22484609 ↗
• MalfunctionAug 31, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHILE RESETTING TRAYS THE SALES REP FOUND ISSUES WITH THE INSTRUMENTS IN QUESTION. THE TIP OF THE DEPTH GAUGE WAS FOUND TO BE BENT, THE QUICK CONNECT SCREWDRIVER WOULD NOT ENGAGE WITH DRIVER SHAFTS, AND THE QUICK CONNECT HANDLE WAS BROKEN. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR A DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS-70MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17663881 ↗
• MalfunctionMay 3, 2023Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED ON (B)(6) 2023, IT WAS NOTED PRE-OPERATIVELY, THE TIP HAD BROKEN OFF DEPTH GAUGE AND THE DEVICE WAS BENT TOO. THERE WAS NO PATIENT INVOLVEMENT. IT IS UNKNOWN WHEN THE DEVICE BROKE. IT WAS NOTED THERE WERE 2 DEPTH GAUGES AFFECTED. THIS IS REPORT 2 OF 2 FOR (B)(4). THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 2.0 AND 2.4 SCREWS-70.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16864908 ↗
• MalfunctionApr 24, 2023Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED ON (B)(6) 2023, THE TIP HAD BROKEN OFF DEPTH GAUGE AND THE DEVICE WAS BENT TOO. THERE WAS NO PATIENT INVOLVEMENT. IT IS UNKNOWN WHEN THE DEVICE BROKE. THIS IS REPORT 1 OF 1 (B)(4). THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 2.0 AND 2.4 SCREWS-70.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16796284 ↗
• MalfunctionDec 5, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE LOCKING TOWERS WERE STRIPPED AND THE DEPTH GAUGE WAS BENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS-70MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15918109 ↗
• MalfunctionDec 5, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE LOCKING TOWERS WERE STRIPPED AND THE DEPTH GAUGE WAS BENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS-70MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15918009 ↗
• MalfunctionDec 5, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE LOCKING TOWERS WERE STRIPPED AND THE DEPTH GAUGE WAS BENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS-70MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15917943 ↗
• MalfunctionJul 7, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6)2022, THE DEPTH GAUGE TIPS BROKE OFF DURING PROCESSING. NO REVISION SURGERY OR HARDWARE REMOVAL REQUIRED. NO MEDICAL INTERVENTION WAS REQUIRED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS-70MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14944853 ↗
• MalfunctionApr 5, 2022Material Deformation; Mechanical Jam; Material Deformation; Mechanical Jam

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2022, DURING POST OP INSPECTION IT WAS IDENTIFIED THAT DEPTH GAUGES WERE STIFF AND DON'T SLIDE AND THE LOCKING COMPRESSION PLATE HAS STRIPPED LOCKING HOLE. THERE WAS NO KNOW PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS-70MM. THIS IS REPORT 4 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14014113 ↗
• MalfunctionApr 5, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2022, DURING POST OP INSPECTION IT WAS IDENTIFIED THAT DEPTH GAUGES WERE STIFF AND DON'T SLIDE AND THE LOCKING COMPRESSION PLATE HAS STRIPPED LOCKING HOLE. THERE WAS NO KNOW PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS-70MM. THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14014101 ↗
• MalfunctionMar 15, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON UNKNOWN DATE, DURING A SET AUDIT, ONE (1) DEPTH GAUGE FOR 2.0 AND 2.4 SCREWS-70 WAS FOUND BROKEN AFTER THE SET WAS WASHED IN STERILE PROCESSING DEPARTMENT (SPD). NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES ONE (1) DEVICE DEPTH GAUGE FOR 2.0 AND 2.4 SCREWS-70. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13773786 ↗
• MalfunctionFeb 1, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE 2.0/2.4MM DEPTH GAUGE WAS FOUND BY STERILE PROCESSING DEPARTMENT TO BE MISSING THE ANTIROTATION PIN FROM THE OUTER SLEEVE OF THE DEPTH GAUGE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS-70MM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13417010 ↗
• MalfunctionDec 29, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, THE DEPTH GAUGE WAS FOUND DEFECTIVE. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 2.0/2.4MM SCREWS-70MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13114666 ↗
• MalfunctionMar 2, 2021Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE FOUR DEPTH GAUGE SLEEVES WERE FOUND AFTER SETS HAD BEEN THROUGH DECONTAMINATION AND THE INNER PART OF THE DEPTH GAUGE HAD BEEN DISPOSED OF BY CENTRAL STERILE STAFF DUE TO THE INNER PART OF THE DEPTH GAUGE BEING BENT OR BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS-70MM. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11401715 ↗
• MalfunctionFeb 2, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE STERILE PROCESSING DEPARTMENT MANAGER FOUND TWO (2) BROKEN DEPTH GAUGES. BOTH HAD THE HOOK BROKEN OFF FROM THE SHAFT OF DEPTH GAUGE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS-70MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11267932 ↗
• MalfunctionFeb 2, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE STERILE PROCESSING DEPARTMENT MANAGER FOUND TWO (2) BROKEN DEPTH GAUGES. BOTH HAD THE HOOK BROKEN OFF FROM THE SHAFT OF DEPTH GAUGE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS-70MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11267915 ↗
• MalfunctionDec 28, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TWO (2) DEPTH GAUGES WERE FOUND WITH THE MEASURING PORTION BROKEN OFF/MISSING IN THE STERILE PROCESSING DEPARTMENT (SPD) AFTER COMING THROUGH THE WASH. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS-70MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11077126 ↗
• MalfunctionDec 28, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TWO (2) DEPTH GAUGES WERE FOUND WITH THE MEASURING PORTION BROKEN OFF/MISSING IN THE STERILE PROCESSING DEPARTMENT (SPD )AFTER COMING THROUGH THE WASH. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS-70MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11077125 ↗
• MalfunctionApr 30, 2020Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE, ONE (1) TRIGGER HANDLE FOR CABLE CUTTER, ONE (1) INTER-LOCK SCREWDRIVER, ONE (1) DEPTH GAUGE, ONE (1) DRIVE ADAPTOR, THREE (3) REDUCTION FORCEPS AND ONE (1) POINTED REDUCTION CLAMP WERE HANDED BY THE FACILITY ORTHO DIRECTOR TO THE SALES CONSULTANT AS ALL THE DEVICES WERE BROKEN. IT IS UNKNOWN IF THERE WERE PATIENT AND SURGICAL INVOLVEMENT. THIS COMPLAINT INVOLVES EIGHT (8) DEVICES. THIS IS REPORT 3 OF 8 FOR PC- (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10015188 ↗
• MalfunctionDec 4, 2019Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE, THE END OF THE DEPTH GAUGE WAS NOTICED TO HAVE BROKEN OFF. THE ISSUE WAS DISCOVERED BY THE STERILE PROCESSING DEPARTMENT (SPD) STAFF. THERE WERE NO PATIENT AND SURGICAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9411919 ↗
• MalfunctionSep 24, 2019Break; Break

  IT WAS REPORTED ON (B)(6) 2019 BY THE SENIOR PROCESSING DEPARTMENT MANAGER ABOUT A DEPTH GAUGE THAT HAD A BROKEN SHAFT. THERE IS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 2.0 MM AND 2.4 MM SCREWS-70 MM THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9111386 ↗
• MalfunctionJul 26, 2019Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE, THE TIP OF THE DEPTH GAUGE WAS MISSING. THE ISSUE WAS DISCOVERED DURING AN INSPECTION BY THE STERILE PROCESSING STAFF. THERE WAS NO PROCEDURE AND PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8830470 ↗