DELTA XTEND 2307-91-001Recalls & reported problems
Depuy (Ireland) · DELTA Xtend SCREW DEPTH GAUGE · Class 1
All models of DELTA XTEND (194)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Delta Xtend depth gauge is a measuring tool used to check screw depth during orthopedic surgery. Reports mostly describe the plastic body snapping or coming apart, sometimes found bent or broken on arrival or after sterilization cycles, with pieces going missing. There are 54 reports, no deaths and no injuries. 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
- 54
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 10603295116554), received between Oct 9, 2017 and Dec 30, 2025 — classified as 54 malfunctions.
The most frequently reported specific device problem is “Break” (31 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
- Break31
- Detachment of Device or Device Component6
- Material Deformation6
- Bent3
- Incorrect Measurement2
- Naturally Worn2
- Adverse Event Without Identified Device or Use Problem1
- Component Missing1
Patient problems
- No Clinical Signs, Symptoms or Conditions36
- No Consequences Or Impact To Patient12
- Insufficient Information4
- No Information2
Recent adverse event reports
The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 30, 2025Break; Break
IT WAS REPORTED THAT THE DEPTH GAUGE FELL APART, THERE WAS NO DELAY IN THE CASE. EVERY THING WAS FINE, NO PARTS WERE LOST. NO ISSUES WITH THE CASE NO ISSUES WITH THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23927037 ↗MalfunctionDec 12, 2025Material Deformation; Material Deformation
IT WAS REPORTED CSSD ALERTED THAT DEPTH GAUGE ON CONSIGNMENT IS BENT. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23791330 ↗MalfunctionOct 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THERE WAS A MISSING SCREW ON A 4 PIECE SCREWDRIVER. DEVICE WAS FOUND IN STERILE PROCESSING. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23227603 ↗MalfunctionJun 24, 2025Break; Break
IT WAS REPORTED THAT THE DEPTH GAUGE ON THE SET WAS BROKEN UPON ARRIVAL. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22318010 ↗MalfunctionMar 27, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025. WHEN OPENING THE SETS PRIOR TO SURGERY, IT WAS DETERMINED THAT THE DEPTH GAUGE AND VERSION ROD WERE BOTH BENT.
Patient problems: Insufficient Information
MAUDE report 21708054 ↗MalfunctionNov 21, 2024Break; Break
IT WAS REPORTED THE DEPTH GAUGE WAS BROKE; MAIN PLASTIC BODY OF DEPTH GAUGE SNAPPED. BREAKAGE DID NOT HAPPEN IN SURGERY. MAIN PLASTIC BODY OF DEVICE FRAGILE/BRITTLE POSSIBLY FROM LONG TERM EXPOSURE TO HEAT CYCLES FROM STERILIZATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20747030 ↗MalfunctionNov 19, 2024Break; Break
IT WAS REPORTED THAT DURING A PRIMARY REVERSE TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2024, THE SURGEON NOTED THAT THE METAL SLEEVE OF THE SCREW DEPTH GAUGE WAS MISSING. THE PIECE WAS NOT PRESENT DURING THE SURGERY. THERE WERE NO COMPLICATIONS OR BROKEN PIECES IN THE SURGERY.
Patient problems: Insufficient Information
MAUDE report 20723435 ↗MalfunctionOct 17, 2024Break; Break
IT WAS REPORTED THAT DUE TO A BROKEN DEPTH GAGE THIS CAUSED ANOTHER HOSPITALS TRAY TO BE BORROWED SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20470410 ↗MalfunctionSep 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE INSTRUMENT IS MISSING THE BLACK CAP OFF THE END OF IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20266047 ↗MalfunctionJul 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
DEPTH GAUGE IS MISSING A COMPONENT. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19681426 ↗MalfunctionJul 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE DEPTH GAUGE IS MISSING A COMPONENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19643136 ↗MalfunctionJun 19, 2024Break; Break
IT WAS REPORTED THAT THE GAUGE DOES NOT RUN SMOOTH AND HAS A BROKEN TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19566997 ↗MalfunctionApr 22, 2024Break; Break
IT WAS REPORTED THAT THE DEPTH GAUGE BROKE. NO PIECES WERE LEFT INSIDE PATIENT.
Patient problems: Insufficient Information
MAUDE report 19152549 ↗MalfunctionApr 17, 2024Break; Break
IT WAS REPORTED THAT THE DEPTH GAUGE BROKE. NO PIECES WERE LEFT INSIDE PATIENT. UNKNOWN SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19127236 ↗MalfunctionApr 16, 2024Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE DEPTH GAUGE WAS NOT READING ACCURATE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19116452 ↗MalfunctionMar 28, 2024Material Deformation; Material Deformation
ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS STATED THAT THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18995248 ↗MalfunctionJan 31, 2024Break; Break
IT WAS REPORTED THAT THE DEPTH GAUGE BROKE DURING USE. NO DELAY REPORTED. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? UNKNOWN, WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN, WERE FRAGMENTS GENERATED? UNKNOWN, 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 NONE 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 18614382 ↗MalfunctionDec 8, 2023Break; Break
IT WAS REPORTED THAT THE DEPTH GAUGE BROKE DURING SURGERY. ALL PIECES WERE RETRIEVED FROM PATIENT.
Patient problems: Insufficient Information
MAUDE report 18289994 ↗MalfunctionOct 23, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE GAUGED IS MISSING A COMPONENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17984799 ↗MalfunctionAug 28, 2023No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE (B)(6) TRAY HAD BEEN DELIVERED TO THE HOSPITAL MISSING AN ITEM (230784003) AND WITH ONE ITEM INCOMPLETE (230791001).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17631813 ↗MalfunctionAug 8, 2023Break; Break
IT WAS REPORTED THAT THE BLACK TIP BROKE AND DOES NOT FIT IN THE DEPTH GAUGE ANYMORE. NO PIECES WERE LEFT IN PATIENT. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17479193 ↗MalfunctionJul 12, 2023Break; Break
IT WAS REPORTED THAT THE DEPTH GAUGE WAS BROKEN IN SPD IN THE CENTER WHERE SCREW LENGTH IS READ.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17313345 ↗MalfunctionJun 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE BLACK KNOB WAS MISSING FROM DEPTH GAUGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17164008 ↗MalfunctionMay 5, 2023Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
IT WAS REPORTED THAT DEPTH GAUGE WAS BENT AND THE BLACK PIECE ON BOTTOM WAS FRAYED AND CROSS THREADED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16876362 ↗MalfunctionMar 24, 2023Break; Break
IT WAS REPORTED THAT DEPTH GAUGE WAS MISSING GAUGE BLACK TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16612305 ↗
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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