DELTA XTEND 2307-93-000Recalls & reported problems
Depuy (Ireland) · DELTA Xtend 3,5 MM CANNULATED HEX SCREWDRIVER · 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 screwdriver is a surgical instrument used during shoulder replacement surgery to tighten implant parts. Its 154 reports mostly describe worn parts, bent or broken tips, and handles sliding off, and most say no patient consequences were reported. The reports include no deaths and no injuries. No recalls name this device. Reports dropped from 5 in the year before to 1 in the latest 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
- 154
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 154 adverse event reports that list this exact device (DI 10603295116585), received between Aug 25, 2017 and Nov 24, 2025 — classified as 154 malfunctions.
The most frequently reported specific device problem is “Naturally Worn” (63 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
- Naturally Worn63
- Material Twisted/Bent49
- Material Deformation27
- Break23
- Device-Device Incompatibility14
- Appropriate Device Problem Term/Code Not Available7
- Adverse Event Without Identified Device or Use Problem1
- Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions75
- No Consequences Or Impact To Patient69
- No Information5
- Not Applicable4
- No Code Available3
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 154 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 24, 2025Break; Break
IT WAS REPORTED THAT THE YELLOW HANDLE OF THE 3.5 CANNULATED HEX DRIVER SLID OFF THE SHAFT. NO DELAYS IN THE SURGERY OCCURRED, AND THE SURGEON WAS ABLE TO COMPLETE THE CASE WITH NO COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23630425 ↗MalfunctionOct 28, 2025Break; Break
IT WAS REPORTED THAT TIP BROKE OFF OF THE ITEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23402569 ↗MalfunctionApr 29, 2025Break; Break
IT WAS REPORTED THAT DURING INSERTION OF THE GLENOSPHERE THE INSTRUMENT´S TIP BROKE OFF INTRAOPERATIVELY. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21926710 ↗MalfunctionApr 24, 2025Break; Break
IT WAS REPORTED THAT THE SCREWDRIVER SEEMED TO BE COMING APART. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21900459 ↗MalfunctionFeb 5, 2025Break; Break
IT WAS REPORTED THAT PATIENT UNDERWENT SHOULDER REPAIR ON (B)(6) 2025. THE SCREWDRIVER TIP BROKE OFF WHILE INSERTING THE GLENOSPHERE. ALL FRAGMENTS WERE REMOVED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21316047 ↗MalfunctionDec 2, 2024Break; Break
IT WAS REPORTED THAT INTRAOPERATIVELY, THE INSTRUMENT FRACTURED INTO TWO OR MORE PIECES. NO ADVERSE PATIENT CONSEQUENCES, NO SURGICAL DELAY REPORTED. SALES REPRESENTATIVE CONFIRMED THAT THERE WAS MATERIAL DEFECT, BUT THE SCREWDRIVER WAS TILTED BY THE SALES REPRESENTATIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20822456 ↗MalfunctionJan 4, 2024Break; Break
IT WAS REPORTED THAT THE SCREWDRIVER TIP BROKE OFF WHEN TIGHTENING GLENOSOHERE TO BASEPLATE. ALL PARTS RECOVERED NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18448833 ↗MalfunctionNov 28, 2023Break; Naturally Worn; Break; Naturally Worn
THE CANNULATED SCREWDRIVER WAS RECEIVED AS BLIND UNIT HOWEVER, IT COULDN'T BE ASSOCIATED WITH A COMPLAINT OR ANY OTHER EXISTING RECORD. AS A RESULT, THIS COMPLAINT WAS CREATED TO ANALYZE THE RETURNED DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18219008 ↗MalfunctionJun 5, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SCREWDRIVER HANDLE WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17060317 ↗MalfunctionApr 20, 2023Break; Break
IT WAS REPORTED THAT THE YELLOW HANDLE BROKE UPON USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16777179 ↗MalfunctionApr 18, 2023Device-Device Incompatibility; Material Deformation; Naturally Worn; Device-Device Incompatibility; Material Deformation; Naturally Worn
IT WAS REPORTED THAT THE HOSPITAL HAVE SOME DELTA XTEND INSTRUMENTS THAT NEED TO BE EXCHANGED DUE TO GENERAL WEAR AND TEAR, DETAILS ARE AS FOLLOWS: 3.5 MM CANNULATED HEX SCREWDRIVER GENERAL WEAR AND TEAR OVER TIME, THE HEX IS NOW MISSHAPEN AND DUE TO IT BECOMING MORE ROUNDED, DOES NOT GRIP AND ENGAGE WITH THE SCREW SUFFICIENTLY TO TIGHTEN IT. MODULAR HUMERAL STEM TRIAL Ø 10 MM. THE PROXIMAL PART OF THE TRIAL STEM HAS BEEN IMPACTED OVER TIME CAUSING THE CURVATURE OF THE HOLE TO BE SLIGHTLY MISSHAPEN. THIS, HOWEVER, MAKES IT EXTREMELY DIFFICULT TO INSERT THE EPIPHYSIS ONTO THE TRIAL STEM. WITH A LOT OF FORCE, THE EPIPHYSIS CANNOT BE FULLY INSERTED, MEANING THAT IT DOES NOT SIT FLUSH AGAINST THE STEM. TRIALLING IS THEREFORE INACCURATE. SIZE 2 LEFT EPI TRIAL. INSERTION POST DAMAGED TRYING TO INSERT INTO ABOVE BROKEN TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16760828 ↗MalfunctionApr 12, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE HEX END HAS BECOME SLIGHTLY ROUNDED SO IT IS NOT AS EFFECTIVE AS IT SHOULD BE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16724342 ↗MalfunctionMar 20, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE INHANCE REAMER SHAFT BROKE AT THE PLASTIC JUNCTION DURING NORMAL USE. THE YELLOW HEX SCREWDRIVER IS STRIPPED FROM NORMAL USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16577085 ↗MalfunctionMar 16, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE TONG ON FORKED RETRACTOR BENT. THERE WAS NO BROKEN PIECES. NO ADVERSE AFFECTS ON THE PATIENT. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16555548 ↗MalfunctionFeb 20, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE DELTA EXTEND SCREWDRIVER BECOME STRIPPED DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16403694 ↗MalfunctionJan 23, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE TIP OF THE DRIVER IS WORN OUT AND WOULD NOT WORK PROPERLY. CASE WAS NOT DELAYED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16226494 ↗MalfunctionJan 18, 2023Break; Break
ADDITIONAL INFORMATION RECEIVED. INDICATES, THAT THERE WERE NO ADVERSE CONSEQUENCES THAT WOULD AFFECT THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16196279 ↗MalfunctionDec 9, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT A 3.5 CANNULATED SCREWDRIVER TIP WAS BENT. NO ADDITIONAL SURGERY TIME WAS REQUIRED. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15949161 ↗MalfunctionDec 7, 2022Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE TIP OF THE DRIVER IS WORN OUT AND NOT CATCHING SCREWS. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15931553 ↗MalfunctionNov 22, 2022Break; Break
IT WAS REPORTED THAT THE SCREWDRIVER TIP BROKE WHILE TIGHTENING GLENOSPHERE INTO COLLET. THERE WAS A SURGICAL DELAY OF 10 MINS.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15842609 ↗MalfunctionOct 31, 2022Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE DRIVER TIP IS WORN DUE TO LOTS OF USE. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15700250 ↗MalfunctionOct 26, 2022Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE DR. COMPLAINED TIP OF SCREW DRIVER WAS TWISTED AND NEEDING REPLACEMENT. PLEASE SEND A REPLACEMENT TO OUR KNOXVILLE OFFICE. SURGICAL DELAY WAS REPORTED UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15674265 ↗MalfunctionOct 18, 2022Naturally Worn; Naturally Worn
DELTA XTEND YELLOW SCREW DRIVER HAS BECOME WORN AND IS NO LONGER FUNCTIONING AS USUAL. HAS SLOWLY WORSENED OVER TIME. NO ADVERSE EFFECTS TO THE PATIENT. NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15625547 ↗MalfunctionOct 6, 2022Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE CANNULATED HEX SCREWDRIVER HAS THE EDGES ROUNDED OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15551154 ↗MalfunctionSep 29, 2022Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE DRIVER IS WORN FROM EXCESSIVE WEAR. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15508539 ↗
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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