NA SD319.006Recalls & reported problems
Synthes GmbH · 2.0/2.4MM DEPTH GAUGE 50MM · Class 1
Quick summary
This Synthes depth gauge is a surgical measuring tool used with a torque limiting handle during bone plating. The 35 reports mostly describe the gauge breaking, bending, or deforming during surgery, with tips snapping off and the handle coming apart, plus some corrosion and discoloration. No deaths or injuries were reported, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 35
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10886982004949), received between Nov 2, 2020 and Apr 28, 2026 — classified as 35 malfunctions.
The most frequently reported specific device problem is “Break” (28 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.
Reports received per month
Most reported problems
Device problems
- Break28
- Material Deformation9
- Corroded5
- Material Discolored5
- Mechanical Jam4
- Device-Device Incompatibility2
Patient problems
- No Clinical Signs, Symptoms or Conditions28
- No Consequences Or Impact To Patient4
- Insufficient Information3
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 28, 2026Break
IT WAS REPORTED THAT THE TORQUE LIMITING HANDLE'S RETENTION MECHANISM FAILED, CAUSING THE INNER PORTION TO SLIDE OUT AND RENDERING THE HANDLE NONFUNCTIONAL. ADDITIONALLY, THE DEPTH GAUGE WAS BROKEN AT THE HOOKED TIP, RESULTING IN LOSS OF FUNCTION. THERE WAS NO REPORTED PATIENT HARM OR SIGNIFICANT DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25015713 ↗MalfunctionJan 27, 2026Material Deformation
IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, THERE WERE BENT DEPTH GAUGES. DURING A CASE, A TROCAR WAS USED AS A REDUCTION TOOL AND WAS BENT IN THE PROCESS. OPERACE TREPHINES WERE USED FOR BROKEN SCREWS AND DID NOT WORK. NO SURGERY DELAYED DUE TO THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24189046 ↗MalfunctionJan 27, 2026Material Deformation
IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, THERE WERE BENT DEPTH GAUGES. DURING A CASE, A TROCAR WAS USED AS A REDUCTION TOOL AND WAS BENT IN THE PROCESS. OPERACE TREPHINES WERE USED FOR BROKEN SCREWS AND DID NOT WORK. NO SURGERY DELAYED DUE TO THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24189044 ↗MalfunctionJan 23, 2026Break
DEPTH GAUGES TIPS BROKE OFF AND DRILL GUIDE WON'T THREAD INTO PLATE. THERE WAS NO PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24167409 ↗MalfunctionJan 23, 2026Break
DEPTH GAUGES TIPS BROKE OFF AND DRILL GUIDE WON'T THREAD INTO PLATE. THERE WAS NO PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24167408 ↗MalfunctionJan 23, 2026Break
DEPTH GAUGES TIPS BROKE OFF AND DRILL GUIDE WON'T THREAD INTO PLATE. THERE WAS NO PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24167389 ↗MalfunctionSep 18, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam
IT WAS REPORTED THAT THE DEPTH GAUGE WAS NOT SLIDING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23086432 ↗MalfunctionSep 18, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam
IT WAS REPORTED THAT THE DEPTH GAUGE WAS NOT SLIDING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23086389 ↗MalfunctionAug 1, 2025Break; Material Deformation; Break; Material Deformation
IT WAS REPORTED THAT BENT/BROKEN DEPTH GAUGES. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22686778 ↗MalfunctionJul 9, 2025Break; Corroded; Material Discolored; Material Deformation; Break; Corroded; Material Discolored; Material Deformation
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE ITEMS ARE WARPED, THREADS ARE BROKEN AND ARE RUSTED. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22461413 ↗MalfunctionJul 9, 2025Break; Corroded; Material Discolored; Material Deformation; Break; Corroded; Material Discolored; Material Deformation
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE ITEMS ARE WARPED, THREADS ARE BROKEN AND ARE RUSTED. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22461404 ↗MalfunctionJul 9, 2025Break; Corroded; Material Discolored; Material Deformation; Break; Corroded; Material Discolored; Material Deformation
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE ITEMS ARE WARPED, THREADS ARE BROKEN AND ARE RUSTED. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22461401 ↗MalfunctionJul 9, 2025Break; Corroded; Material Discolored; Material Deformation; Break; Corroded; Material Discolored; Material Deformation
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE ITEMS ARE WARPED, THREADS ARE BROKEN AND ARE RUSTED. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22461394 ↗MalfunctionJul 9, 2025Break; Corroded; Material Discolored; Material Deformation; Break; Corroded; Material Discolored; Material Deformation
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE ITEMS ARE WARPED, THREADS ARE BROKEN AND ARE RUSTED. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22461380 ↗MalfunctionJan 17, 2025Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, DEPTH GAUGE TIPS WERE BROKEN. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21181085 ↗MalfunctionJan 17, 2025Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, DEPTH GAUGE TIPS WERE BROKEN. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21181076 ↗MalfunctionJan 17, 2025Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, DEPTH GAUGE TIPS WERE BROKEN. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21181061 ↗MalfunctionJan 17, 2025Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE 2.0/2.4 DEPTH GAUGES WERE BROKEN. THE PATIENT STATUS/ OUTCOME / CONSEQUENCES IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 21180816 ↗MalfunctionJan 17, 2025Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE 2.0/2.4 DEPTH GAUGES WERE BROKEN. THE PATIENT STATUS/ OUTCOME / CONSEQUENCES IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 21180811 ↗MalfunctionJan 17, 2025Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE 2.0/2.4 DEPTH GAUGES WERE BROKEN. THE PATIENT STATUS/ OUTCOME / CONSEQUENCES IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 21180807 ↗MalfunctionSep 12, 2024Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, TIP OF DEPTH GAUGES WERE BROKEN. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20199297 ↗MalfunctionSep 12, 2024Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, TIP OF DEPTH GAUGES WERE BROKEN. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20199286 ↗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) 2.0/2.4MM DEPTH GAUGE 50MM. THIS IS REPORT 3 OF 5 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14014111 ↗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) 2.0/2.4MM DEPTH GAUGE 50MM. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14014095 ↗MalfunctionNov 4, 2021Break; Break
IT WAS REPORTED THAT ON (B)(6), 2021, DURING THE SURGERY, THE TIP OF THE DEPTH GAUGE BROKE OFF WHILE FIXING AN OLECRANON FRACTURE. THERE WERE 3-MINUTES SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 2.0/2.4MM DEPTH GAUGE 50MM. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12753763 ↗
Other GAUGE, DEPTH devices
- NA 319.006Synthes GmbH · GAUGE, DEPTH899 reports
- NA 03.133.080Synthes GmbH · GAUGE, DEPTH174 reports
- NA 03.010.072Synthes GmbH · GAUGE, DEPTH133 reports
- MULTILOC 03.019.017Synthes GmbH · GAUGE, DEPTH119 reports
- NA 319.01Synthes GmbH · GAUGE, DEPTH113 reports
- NA 319.004Synthes GmbH · GAUGE, DEPTH82 reports
- QUICKSET 2274-60-000Depuy (Ireland) · GAUGE, DEPTH68 reports
- NA 319.09Synthes GmbH · GAUGE, DEPTH65 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.