NA 2274-36-000Recalls & reported problems
Depuy (Ireland) · DEPTH GAUGE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy depth gauge is a surgical instrument used to measure screw depth during bone fixation. The 31 reports mostly describe the tool breaking, bending, or coming apart during use or inspection, along with a few cases of it giving wrong measurements or not fitting with other instruments. No deaths and no injuries were reported. 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
- 30
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10603295109198), received between Aug 13, 2018 and Aug 6, 2026 — classified as 30 malfunctions.
The most frequently reported specific device problem is “Break” (17 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break17
- Material Deformation4
- Material Twisted/Bent4
- Detachment of Device or Device Component3
- Device-Device Incompatibility3
- Incorrect Measurement3
- Defective Device1
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- No Consequences Or Impact To Patient11
- Insufficient Information4
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 6, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50158752 ↗MalfunctionAug 28, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT 25MM DRILL WAS BROKEN AND DEPTH GAUGE WAS BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22917664 ↗MalfunctionAug 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THERE WAS A MISSING ATTACHMENT. THE ISSUE WAS IDENTIFIED DURING LOAN KIT INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22893797 ↗MalfunctionJun 30, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THERE IS A BENT COIL ON A DEPTH GAUGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22358206 ↗MalfunctionFeb 13, 2025Break; Break
IT WAS REPORTED THAT THE NUT THAT HOLDS THE GAUGE TOGETHER BROKE. NO SURGICAL DELAY. GAUGE BEING RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21377329 ↗MalfunctionDec 6, 2024Break; Break
IT WAS REPORTED THAT THE TIP OF DEPTH GAUGE WAS BROKE OFF AFTER MEASURING SCREW LENGTH. THERE WAS NO SURGICAL DELAY AS TIP WAS EASILY REMOVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20866054 ↗MalfunctionAug 28, 2024Break; Break
IT WAS REPORTED THAT IMPACTOR HANDLE, RESECTION WING AND DEPTH GAUGE WERE BROKEN.
Patient problems: Insufficient Information
MAUDE report 20085467 ↗MalfunctionMay 20, 2024Incorrect Measurement; Material Deformation; Incorrect Measurement; Material Deformation
IT WAS REPORTED THAT UPON INSPECTION, THE SHAFT OF THE DEPTH GAUGE WAS BENT AND UNABLE TO MEASURE. THIS WAS NOTICED PRIOR TO THE CASE STARTING. THE DEPTH GAUGE WAS DISPOSED OF AND NO HARM OCCURRED TO THE PATIENT AND THERE WAS NO DELAY IN SURGICAL TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19350677 ↗MalfunctionFeb 21, 2024Break; Break
IT WAS REPORTED THAT PINNACLE BONE SCREW DEPTH GAUGE BROKE DURING SURGERY SET UP. SURGICAL DELAY UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 18750753 ↗MalfunctionFeb 18, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT DEPTH GAUGE IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18728556 ↗MalfunctionJan 4, 2024Break; Break
IT WAS REPORTED THAT THE DEPTH GAUGE BROKE. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? : NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? : YES, WERE FRAGMENTS GENERATED? -: NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? : UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES : NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, (B)(4). DEVICE PROPERTY OF : NONE, DEVICE IN POSSESSION OF : UVM BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.: TRUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18444661 ↗MalfunctionDec 27, 2023Material Deformation; Material Deformation
IT WAS REPORTED THAT THE FLEXIBLE DEPTH GAUGE WAS BENT. THERE WAS NO PATIENT CONSEQUENCE OR SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18401054 ↗MalfunctionNov 28, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT WHILE MEASURING SCREW WITH DEPTH GAUGE, SPRING MALFUNCTIONED AND WOULD NOT ATTACH TO GAUGE. BROKEN PIECE DISPOSED OF. THERE WAS NO HARM TO PATIENT AND NO DELAY IN SURGICAL TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18215932 ↗MalfunctionNov 1, 2022Break; Break
IT WAS REPORTED THAT THE ACETABULAR SCREW DEPTH GAUGE BROKE. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15708294 ↗MalfunctionSep 27, 2022Break; Break
IT WAS REPORTED THAT THE DEPTH GAUGE BROKE DURING CLEANING. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15490555 ↗MalfunctionJan 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
SPRING ON DEPTH GAUGE IS BROKEN. DID NOT OCCUR DURING SURGERY SO NO SURGICAL DELAY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13289000 ↗MalfunctionJan 6, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE THREADED PIECE OF DEPTH GAUGE WAS CROSS THREADED AND WOULD NOT SCREW DOWN. SURGICAL DELAY 2MINS.
Patient problems: Insufficient Information
MAUDE report 13174638 ↗MalfunctionApr 29, 2021Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE RIBBED COLLAR ON THE DEPTH GAUGE DOES NOT ¿CATCH¿ OR STOP AT THE PORTION THAT IS INSERTED INTO THE SCREW HOLE. NO DELAY TO SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11743851 ↗MalfunctionMar 29, 2021Break; Break
IT WAS REPORTED THAT THE DEPTH GAUGE SPRING BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11585648 ↗MalfunctionAug 25, 2020Break; Break
IT WAS REPORTED THAT THE TIP OF THE DEPTH GAUGE HAS BROKEN OFF. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10449434 ↗MalfunctionAug 3, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT UPON REASSEMBLY AFTER SURGERY, DEPTH GAUGE BENT AND UNUSABLE. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10360212 ↗MalfunctionOct 25, 2019Break; Break
MalfunctionOct 7, 2019Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT THE DEPTH GAUGE BENT AND BALL BEARING WON'T HOLD IN PLACE. FOUND WHEN SET RETURNED TO THE OFFICE FOR INSPECTION. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9161887 ↗MalfunctionAug 21, 2019Break; Material Twisted/Bent; Break; Material Twisted/Bent
IT WAS REPORTED THAT THE DEPTH GAUGE WAS BROKEN WHEN TRAY WAS OPENED AT THE BEGINNING OF CASE. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8915287 ↗MalfunctionJul 17, 2019Break; Break
IT WAS REPORTED THAT THE DEPTH GAUGE BROKE INTO TWO PIECES AS IT WAS BEING PULLED OUT OF THE ACETABULUM AFTER IT HAD BEEN USED TO GAUGE THE SIZE OF THE FIRST SCREW. ALL PIECES (TWO TOTAL PIECES) HAVE BEEN RETRIEVED AND NO ADVERSE AFFECTS HAD HAPPENED AS A RESULT. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8799685 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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