DELTA XTEND 2307-90-003Recalls & reported problems
Depuy (Ireland) · DELTA Xtend GLENOID DRILL GUIDE DIA 2.5 MM · Class 2
All models of DELTA XTEND (194)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is the DePuy Delta Xtend glenoid drill guide, a surgical tool used in shoulder replacement procedures. The 43 reports almost all describe the guide breaking, often in half or where the handle meets the drill shaft, sometimes during loan kit inspection rather than in surgery. No deaths and no injuries were reported, and reports note procedures were completed with no patient consequences. There are no recalls naming this device, and reporting has slowed in the past year.
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
- 43
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10603295116523), received between Sep 29, 2017 and Dec 17, 2025 — classified as 43 malfunctions.
The most frequently reported specific device problem is “Break” (38 reports).
8 other recalls cover devices cleared under the same FDA submission (K170748); they may or may not involve this specific model.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break38
- No Apparent Adverse Event2
- Device-Device Incompatibility1
- Material Deformation1
- Separation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- No Consequences Or Impact To Patient18
- Insufficient Information4
- No Code Available2
- No Information1
- Not Applicable1
Recent adverse event reports
The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 17, 2025Break; Break
¿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 AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. GLENOID DRILL GUIDE HAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23827172 ↗MalfunctionNov 6, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED ON (B)(6) 2025 THE DRILL GUIDE BROKE BETWEEN HANDLE END STEM. PROCEDURE COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23488305 ↗MalfunctionOct 16, 2025Break; Break
IT WAS REPORTED THAT A DRILL GUIDE BROKE BETWEEN THE HANDLE AND THE STEM. ANOTHER DRILL GUIDE WAS ALSO BROKEN. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23309643 ↗MalfunctionOct 15, 2025Break; Break
IT WAS REPORTED ON (B)(6) 2025, THE DRILL GUIDE BROKE BETWEEN HANDLE END STEM. PROCEDURE COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23294985 ↗MalfunctionJul 14, 2025Break; Break
IT WAS REPORTED THAT THE DRILL GUIDE BROKE AT THE HANDLE/DRILL SHEATH JUNCTION. BOTH PIECES WERE RECOVERED. THERE WAS NO ADVERSE EVENT AND NO DELAY TO THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22496798 ↗MalfunctionFeb 10, 2025No Apparent Adverse Event; No Apparent Adverse Event
A DEVICE WAS RECEIVED FOR ANALYSIS. THERE WAS NO PRODUCT MALFUNCTION OR PATIENT HARM REPORTED WITH THE RETURNED DEVICE.
Patient problems: Insufficient Information
MAUDE report 21349205 ↗MalfunctionJan 23, 2025Break; Break
IT WAS REPORTED THAT THE DRILL GUIDE BROKE IN HALF.
Patient problems: Insufficient Information
MAUDE report 21218433 ↗MalfunctionJul 2, 2024Break; Break
IT WAS REPORTED THAT THE DRILL GUIDE BROKE IN HALF. ALL PIECES WERE FOUND.
Patient problems: Insufficient Information
MAUDE report 19656235 ↗MalfunctionMay 23, 2024Break; Break
IT WAS REPORTED THAT THE DRILL GUIDE BROKE . NO PIECES WERE LEFT INSIDE THE PATIENT. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 19380301 ↗MalfunctionFeb 9, 2024Break; Break
IT WAS REPORTED THAT THE DRILL GUIDE BROKE IN HALF. NO PIECES WERE LEFT INSIDE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18676341 ↗MalfunctionDec 20, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE LINER TRIAL WAS SCRATCHED. DRILL GUIDE WOULD NOT ALLOW DRILL BIT TO PASS THROUGH EASILY. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18364526 ↗MalfunctionSep 28, 2023Break; Break
T WAS REPORTED THAT WHEN USING THE 2.5 DRILL GUIDE, THE HANDLE SNAPPED OFF. THERE WAS NO PATIENT CONSEQUENCE OR DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17840758 ↗MalfunctionJun 20, 2023Break; Break
IT WAS REPORTED THAT THE DRILL GUIDE BROKE. UNKNOWN SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17162302 ↗MalfunctionDec 27, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT THE INSTRUMENT HANDLE WAS BENT. REMOVED FROM FIELD NO FURTHER INFO AVAILABLE. NO SURGICAL DELAY WAS THERE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16053216 ↗MalfunctionNov 4, 2022Break; Break
IT WAS REPORTED THAT THE INSTRUMENT WAS BROKE IN HALF. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15725757 ↗MalfunctionSep 20, 2022Break; Break
IT WAS REPORTED THAT THE PRODUCT WAS BROKE DURING SURGERY. NO PIECES WERE LEFT IN THE PATIENT. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15456807 ↗MalfunctionAug 25, 2022Break; Break
IT WAS REPORTED THAT THE TISSUE PROTECTOR BROKE WHILE IN USE. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15293956 ↗MalfunctionJul 21, 2022Break; Break
IT WAS REPORTED THAT THE DRILL GUIDE WAS FOUND TO BE BROKEN AFTER WASH/STERILIZATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15072797 ↗MalfunctionMar 31, 2022Break; Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13965927 ↗MalfunctionNov 16, 2021Break; Break
IT WAS REPORTED THAT THIS INSTRUMENT WAS UTILIZED IN THE CASE WITHOUT INCIDENT. IT WAS NOTICED THAT THE INSTRUMENT WAS BROKEN AFTER IT CAME OUT OF THE WASHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12824394 ↗MalfunctionNov 16, 2021Break; Break
IT WAS REPORTED THAT THIS INSTRUMENT WAS UTILIZED IN THE CASE WITHOUT INCIDENT. IT WAS NOTICED THAT THE INSTRUMENT WAS BROKEN AFTER IT CAME OUT OF THE WASHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12824387 ↗MalfunctionJun 23, 2021Break; Break
IT WAS REPORTED THAT THE TOP OF SCREW ALIGNMENT GUIDE BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12051132 ↗MalfunctionFeb 9, 2021Break; Break
IT WAS REPORTED THAT THE DRILL GUIDE BROKE COMPLETELY OFF AT THE JOINT BETWEEN THE FLAT HANDLE AND THE CYLINDRICAL DRILL GUIDE WHILE DRILLING. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11303623 ↗MalfunctionOct 12, 2020Break; Break
IT WAS REPORTED THAT A 2.5MM DRILL GUIDE BROKE AT THE WELD IN THE WASH.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10662111 ↗MalfunctionMar 5, 2020Break; Break
IT WAS REPORTED THAT THE DRILL GUIDE BROKE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9794468 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K170748. One submission often covers many models, so check the product and lot details in each record.
- Z-0487-2022 · Dec 7, 2021 · TerminatedGLOBAL UNITE REV STEM SZ 10 Product Code: 110010600
- Z-0488-2022 · Dec 7, 2021 · TerminatedGLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
- Z-0483-2022 · Dec 7, 2021 · TerminatedGLOBAL UNITE STD STEM SZ 6 Part Number: 11000610
- Z-0490-2022 · Dec 7, 2021 · TerminatedGLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
- Z-0489-2022 · Dec 7, 2021 · TerminatedGLOBAL UNITE STD STEM SZ 14 Product Code: 110014100
- Z-0486-2022 · Dec 7, 2021 · TerminatedGLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
- Z-0484-2022 · Dec 7, 2021 · TerminatedGLOBAL UNITE STD STEM SZ 8 Part Number: 110008100
- Z-0485-2022 · Dec 7, 2021 · TerminatedGLOBAL UNITE REV STEM SZ 8 Part Number: 110008600
Other shoulder prosthesis, reverse configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 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 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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