DELTA XTEND 2307-92-004Recalls & reported problems
Depuy (Ireland) · DELTA Xtend LOCKING SCREWDRIVER INTERNAL ROD · 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 locking screwdriver is a surgical tool for tightening screws during shoulder replacement surgery. The 24 reports describe the tip breaking during use, sometimes leaving a small fragment that was retrieved, and tools wearing out over time, with no deaths and no injuries mentioned. 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
- 24
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10603295116578), received between Oct 27, 2017 and Feb 6, 2026 — classified as 24 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
- Naturally Worn3
- Device-Device Incompatibility2
- Material Deformation2
- Material Twisted/Bent2
- Adverse Event Without Identified Device or Use Problem1
- Detachment of Device or Device Component1
- Device Contaminated During Manufacture or Shipping1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- No Consequences Or Impact To Patient11
- Insufficient Information1
- No Information1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 6, 2026Break; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT DURING A REVERSE SHOULDER ARTHROPLASTY PROCEDURE, WHILE LOCKING ONE OF THE LOCKING SCREWS, THE INNER TIP OF THE LOCKING SCREWDRIVER FRACTURED. NO HARM WAS CAUSED TO THE PATIENT, NO FOREIGN BODY REMAINED, AND THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24282448 ↗MalfunctionMar 5, 2024Break; Break
IT WAS REPORTED THAT THE DEVICE WAS BROKEN. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18839558 ↗MalfunctionDec 6, 2023Break; Break
IT WAS REPORTED THAT THIS WAS AN RSA FOR DEGENERATIVE DISEASE OF THE SHOULDER ON (B)(6) 2023. DURING USE, A PART OF THE TIP OF THE SCREWDRIVER BROKE OFF. THE BROKEN FRAGMENT WAS REMOVED FROM THE PATIENT¿S BODY. THERE WAS NO HARM TO THE PATIENT AND NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18273934 ↗MalfunctionJul 5, 2022Break; Material Deformation; Naturally Worn; Break; Material Deformation; Naturally Worn
IT WAS REPORTED THAT THE INSTRUMENT WAS REPORTED TO BE BROKEN/WORN OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14914667 ↗MalfunctionMay 23, 2022Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
ONE OF THE 4 TEETH ON LOCKING SCREWDRIVER BROKE WHILE TIGHTENING SCREW INTO METAGLENE. ONE OF THE TEETH BECAME STUCK IN THE SCREW. SURGICAL DELAY OF 10 MINUTES OCCURRED. NO ADVERSE AFFECTS ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14479708 ↗MalfunctionMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE INSTRUMENT WAS REPORTED FOR UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 13771167 ↗MalfunctionDec 29, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING CASE SUPPORT OF COMPLAINT REPORTED UNDER (B)(4) IT WAS NOTED THAT SOME INSTRUMENTS ARE VERY WORN AND NEED REPLACING, THE ACCOUNT HAS HAD NO REP SUPPORT FOR 2 YEARS SO THE KIT IS IN THE NEED FOR SOME ITEMS TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13113046 ↗MalfunctionOct 7, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE FOLLOWING INSTRUMENTS WERE WORN BEYOND SURGICAL USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12593536 ↗MalfunctionJul 23, 2021Break; Break
IT WAS REPORTED THAT THE ONE OF THE TIPS AT THE END OF THE SCREW DRIVER BROKE OFF WHEN TRYING TO REMOVE A SCREW. THE FRAGMENT OF THE SCREWDRIVER WAS FOUND AND REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12218573 ↗MalfunctionFeb 18, 2021Break; Break
IT WAS REPORTED THAT THE YELLOW SCREW DRIVER HANDLE TIP IS WORN DOWN. GREEN LOCKING SCREW TOOTH BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11343264 ↗MalfunctionFeb 10, 2021Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE GREEN DIAL PIECE OF DRIVER IS STRIPPED. HANDLE SLIDES FORWARD AND FALLS APART MAKING IT HARD TO TURN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11311514 ↗MalfunctionDec 8, 2020Break; Break
IT WAS REPORTED THAT THE ONE TAB BROKE OFF THE DELTA XTEND LOCKING SCREWDRIVER. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10969920 ↗MalfunctionOct 21, 2020Break; Break
IT WAS REPORTED THAT THERE WAS A BROKEN LOCKING SCREWDRIVER TIP. IT DID NOT IMPACT CASE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10712893 ↗MalfunctionSep 3, 2019Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE LOCKING GREEN SCREW DRIVER INTERNAL ROD WAS STRIPPED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8957785 ↗MalfunctionAug 2, 2019Break; Break
IT WAS REPORTED THAT THE LOCKING ROD WAS BROKEN DURING SURGERY. ALL PRICES WERE RECOVERED AND THE PROCEDURE WAS NOT DELAYED AT ALL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8855522 ↗MalfunctionJun 25, 2019Break; Break
IT WAS REPORTED THAT THE TINES ON LOCKING SCREWDRIVER BROKE WILL TRYING TO TAKE SCREWS OUT. ALL PIECES WERE RECOVERED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8730500 ↗MalfunctionJan 29, 2019Material Deformation; Material Deformation
THE REAMER IS DULL AND THE SURGEONS HAVE HAD TO MAKE SO MUCH FORCE FRACTURED THE BONE, ALSO THE REAMER OF THE STEM IS DULL. AND THE SCREWED SCREW DRIVER DOES NOT TAKE THE SCREW.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8284788 ↗MalfunctionJan 28, 2019Naturally Worn; Naturally Worn
MalfunctionNov 19, 2018Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE YELLOW SCREWDRIVER WOULD NOT ENGAGE AT THE TOP AND THE LONG SKINNY GREEN SCREWDRIVER HAD THE PLASTIC HANDLE DISLODGED FORWARD.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8083884 ↗MalfunctionJun 11, 2018Break; Break
IT WAS REPORTED THAT GREEN SCREWDRIVER USED FOR METAGLENE LOCKING SCREWS WAS CHIPPED AT THE TIP OF THE INNER SCREWDRIVER WHEN LOCKING SCREWS. NO PATIENT INVOLVEMENT,ALL PARTS RETRIEVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7586215 ↗MalfunctionMay 22, 2018Break; Break
MAUDE REPORT RECEIVED. IT WAS REPORTED, DURING A REVERSE SHOULDER PROCEDURE 3 SMALL METAL PRONGS BROKE OFF OF THE DEPUY LOCKING SCREWDRIVER FROM THE DELTA EXTEND GLENOID CASE COMPLETE TRAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7533591 ↗MalfunctionMar 2, 2018Break; Break
IT WAS REPORTED THAT THE SURGEON WAS LOCKING THE LAST LOCKING SCREW ON HIS REVERSE TOTAL SHOULDER, THE LOCKING SCREWDRIVER ROD REF# 230792004 TIP BROKE. LUCKILY THE SCREW HAD BEEN COMPLETELY LOCKED AS IT BROKE. THERE WERE NO PATIENT HARM, AND DID NOT ADD ANY TIME TO THE CASE. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7310172 ↗MalfunctionNov 30, 2017Break; Break
IT WAS REPORTED THAT THE TIP OF HANDLE BROKE WHILE SURGEON WAS LOCKING THE SCREW.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7073846 ↗MalfunctionOct 27, 2017Break; Break
IT WAS REPORTED THAT ONE OF THE LITTLE TEETH AT THE TIP OF THE LOCKING SCREW DRIVER BROKE OFF INTRAOPERATIVELY.
Patient problems: No Information
MAUDE report 6983593 ↗
Other SCREWDRIVER devices
- DELTA XTEND 2307-92-003Depuy (Ireland) · SCREWDRIVER751 reports
- EXPEDIUM 279712400Medos International Sàrl · SCREWDRIVER551 reports
- NA 314.467Synthes GmbH · SCREWDRIVER498 reports
- N/A 5584111Medtronic Sofamor Danek, Inc. · SCREWDRIVER492 reports
- QUICKSET 2274-47-000Depuy (Ireland) · SCREWDRIVER487 reports
- NA 03.130.010Synthes GmbH · SCREWDRIVER1 recall422 reports
- QUICKSET 2274-63-000Depuy (Ireland) · SCREWDRIVER404 reports
- EVOS 71175072Smith & Nephew, Inc. · SCREWDRIVER336 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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