NA 319.006Recalls & reported problems
Synthes GmbH · DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Synthes depth gauge, used to measure screw depth during surgery, appears in 894 adverse event reports. Many describe the gauge breaking, and some mention worn hooks and parts found broken while surgical trays were being assembled. The reports mention no deaths and no injuries, 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
- 899
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 899 adverse event reports that list this exact device (DI 10886982189943), received between Dec 15, 2016 and Sep 29, 2026 — classified as 899 malfunctions.
The most frequently reported specific device problem is “Break” (729 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
- Break729
- Material Deformation61
- Mechanical Jam52
- Use of Device Problem18
- Detachment of Device or Device Component12
- Device-Device Incompatibility11
- Material Twisted/Bent10
- Mechanical Problem9
Patient problems
- No Clinical Signs, Symptoms or Conditions564
- No Patient Involvement172
- No Consequences Or Impact To Patient135
- No Known Impact Or Consequence To Patient18
- Insufficient Information15
- No Code Available2
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 899 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933066 ↗MalfunctionSep 22, 2026Device Slipped
Patient problems: Insufficient Information
MAUDE report 50858391 ↗MalfunctionSep 16, 2026Break
It was reported that the depth gauge was broken. There was no significant delay and there was no patient or user harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50791690 ↗MalfunctionSep 16, 2026Break
It was reported that the depth gauge was broken. There was no significant delay and there was no patient or user harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50791682 ↗MalfunctionSep 16, 2026Break
It was reported that the depth gauge was broken. There was no significant delay and there was no patient or user harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50791678 ↗MalfunctionSep 16, 2026Break
It was reported that the depth gauge was broken. There was no significant delay and there was no patient or user harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50791674 ↗MalfunctionSep 15, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780004 ↗MalfunctionAug 24, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50406396 ↗MalfunctionAug 10, 2026Break; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50192061 ↗MalfunctionJun 3, 2026Break
IT WAS REPORTED THAT THERE WERE 2 ITEMS THAT WERE FOUND BROKEN WHILE GETTING TRAYS PUT TOGETHER. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25374112 ↗MalfunctionJun 3, 2026Break
IT WAS REPORTED THAT THERE WERE 2 ITEMS THAT WERE FOUND BROKEN WHILE GETTING TRAYS PUT TOGETHER. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25374111 ↗MalfunctionMay 19, 2026Break
IT WAS REPORTED THAT ON (B)(6) 2026 BOTH OF THE DEPTH GAUGES ARE BROKEN. ITEMS WERE FOUND WHILE GETTING THE TRAY READY FOR DROP OFF TO A CASE. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25215989 ↗MalfunctionMay 19, 2026Break
IT WAS REPORTED THAT ON APR 30, 2026 BOTH OF THE DEPTH GAUGES ARE BROKEN. ITEMS WERE FOUND WHILE GETTING THE TRAY READY FOR DROP OFF TO A CASE. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25215970 ↗MalfunctionMay 13, 2026Break
IT WAS REPORTED ON AN UNKNOWN DATE THAT THE DEPTH GAUGES KEEP BREAKING AND/OR DISAPPEARING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25163374 ↗MalfunctionMay 12, 2026Break
IT WAS REPORTED ON AN UNKNOWN DATE THAT THE DEPTH GAUGES KEEP BREAKING AND/OR DISAPPEARING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25149000 ↗MalfunctionMay 12, 2026Break
IT WAS REPORTED ON AN UNKNOWN DATE THAT THE DEPTH GAUGES KEEP BREAKING AND/OR DISAPPEARING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25148994 ↗MalfunctionMay 12, 2026Break
IT WAS REPORTED ON AN UNKNOWN DATE THAT THE DEPTH GAUGES KEEP BREAKING AND/OR DISAPPEARING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25148991 ↗MalfunctionMay 12, 2026Break
IT WAS REPORTED ON AN UNKNOWN DATE THAT THE DEPTH GAUGES KEEP BREAKING AND/OR DISAPPEARING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25148975 ↗MalfunctionMay 12, 2026Break
IT WAS REPORTED ON AN UNKNOWN DATE THAT THE DEPTH GAUGES KEEP BREAKING AND/OR DISAPPEARING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25148972 ↗MalfunctionMay 1, 2026Break
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 25056414 ↗MalfunctionMay 1, 2026Break
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 25056409 ↗MalfunctionApr 30, 2026Material Deformation
IT WAS REPORTED THAT THE INSTRUMENTS ARE BENT. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25047070 ↗MalfunctionApr 30, 2026Material Deformation
IT WAS REPORTED THAT THE INSTRUMENTS ARE BENT. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25047063 ↗MalfunctionApr 17, 2026Break
IT WAS REPORTED THAT THE DEPTH GAUGE F/SCR Ø2+2.4 MEAS-RANGE UP-T WAS BROKEN WITH THE TIP DETACHED AFTER THE TRAY WAS RETURNED FROM STERILE PROCESSING. THE EVENT WAS IDENTIFIED POST-OPERATIVELY. THERE WAS NO PATIENT INVOLVEMENT OR IMPACT, AS THE DEVICE FAILURE WAS DISCOVERED DURING SET-UP OR CLEANING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24910453 ↗MalfunctionApr 16, 2026Break
IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24894688 ↗
Other GAUGE, DEPTH devices
- 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
- NA 319.091Synthes GmbH · GAUGE, DEPTH64 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page