DELTA XTEND 2307-74-101Recalls & reported problems
Depuy (Ireland) · DELTA XTEND 145 RSA REAM GUIDE INSERTER · Class 1
All models of DELTA XTEND (194)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Delta Xtend reamer guide inserter is a surgical instrument used during reverse shoulder replacement. Many of the 82 reports describe the handle failing to attach or staying loose, and some describe the handle breaking. The reports include no injuries and no deaths, and reports fell from 14 in the previous 12 months to 5 in the last 12 months. 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
- 82
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 10603295518792), received between Jan 5, 2021 and Mar 23, 2026 — classified as 82 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (52 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility52
- Unintended Movement30
- Break14
- Material Deformation5
- Structural Problem5
- Difficult to Open or Close4
- Naturally Worn2
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions66
- Insufficient Information16
Recent adverse event reports
The 25 most recent of 82 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 23, 2026Break
IT WAS REPORTED THAT THE BROACH HANDLE IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24666833 ↗MalfunctionMar 2, 2026Device-Device Incompatibility
IT WAS REPORTED THAT HANDLE DOESN'T ATTACH TO THE REAMER POST GUIDES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24484729 ↗MalfunctionJan 22, 2026Device-Device Incompatibility
IT WAS REPORTED THAT EPYPHISEAL REAMER HANDLE BECAME LOOSE. IT¿S NOT HOLDING THE GUIDE STEADY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24144142 ↗MalfunctionNov 12, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THERE WAS NO TENSION ON THE LEVER WHEN CLAMPING ONTO THE REAMING GUIDE POST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23534808 ↗MalfunctionNov 4, 2025Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE HANDLE ON THE XTND 145 RSA REAM GUID INSRTR DEVICE WAS LOOSE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23466132 ↗MalfunctionOct 28, 2025Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT DURING A PRIMARY REVERSE TOTAL SHOULDER, THE SCRUB TECH NOTED THAT THE PROXIMAL REAMING GUIDE HANDLE¿S LATCH WAS LOOSE SUCH THAT THE REAMING GUIDE WOULD NOT STAY ENGAGED IN THE HANDLE. THERE WERE NO BROKEN PIECES. THERE WERE NO DELAYS OR COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23402369 ↗MalfunctionOct 21, 2025Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT HANDLE HAS BECOME LOOSE AND DOES NOT HOLD THE EPIPHYSIS REAMER GUIDE STEADY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23350673 ↗MalfunctionAug 20, 2025Unintended Movement; Unintended Movement
WHILE USING THE GLOBAL UNIT SYSTEM FOR A REVERSE TOTAL SHOULDER, THE REAMER GUIDE INSERTER WAS DISCOVERED TO BE NOT FUNCTIONING CORRECTLY AS THE LOCKING MECHANISM SEEMED LOOSE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22850274 ↗MalfunctionAug 6, 2025Structural Problem; Structural Problem
IT WAS REPORTED THAT EPIPHYSEAL BROACH HANDLE DID NOT LOCK ONTO BROACH. THERE WAS NO DELAY IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22731111 ↗MalfunctionJun 25, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT HANDLE DOES NOT LATCH PROPERLY. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22332010 ↗MalfunctionJun 20, 2025Device-Device Incompatibility; Device-Device Incompatibility
ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT THE LATCH OF THE HANDLE APPEARED BROKEN AS THE HANDLE WOULD NOT STAY IN A SECURE POSITION WHEN COMPLETELY CLOSED. NO ADVERSE REACTIONS. INSTRUMENT WAS REMOVED AND ASSIGNED A COMPLAINT NUMBER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22296452 ↗MalfunctionApr 21, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING SHOULDER REPAIR. FACILITY REPORTS THAT THEY BREAK THIS INSTRUMENT IN NORMAL USE AT LEAST ONCE A MONTH.
Patient problems: Insufficient Information
MAUDE report 21874122 ↗MalfunctionApr 21, 2025Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER REPAIR SURGERY AND THE INSTRUMENT WAS BROKEN.
Patient problems: Insufficient Information
MAUDE report 21871770 ↗MalfunctionApr 3, 2025Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE REAMER GUIDE HANDLE WAS LOOSE. THE ISSUE DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21763736 ↗MalfunctionMar 28, 2025Difficult to Open or Close; Unintended Movement; Difficult to Open or Close; Unintended Movement
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER REPAIR SURGERY, AND EPIPHYSIS REAMER HANDLE FROM THE 145 EPI LATERAL TRAY WAS LOOSE AND DID NOT CLOSE PROPERLY. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21719683 ↗MalfunctionMar 17, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE HANDLE DOESN'T STAY LATCHED. THERE IS A RISK OF THE HANDLE OPENING AND DROPPING THE REAMER GUIDE. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 21621334 ↗MalfunctionMar 10, 2025Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT THIS PATIENT HAS A LEFT TOTAL SHOULDER. IT WAS DISCOVERED AFTER REASSEMBLING THE INSTRUMENTS, THAT THE HUMERAL STEM ROTATION GUIDE BROACH HANDLE DID NOT HOLD THE TRIAL PROPERLY AND WAS LOOSE.
Patient problems: Insufficient Information
MAUDE report 21560597 ↗MalfunctionJan 31, 2025Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE LOCKING MECHANISM ON THE REAM GUIDE INSERTER IS LOOSE AND POPS OPEN UNDER VERY LITTLE PRESSURE. THE PRODUCT DAMAGE DOCUMENTED HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE ARE NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21281838 ↗MalfunctionNov 7, 2024Unintended Movement; Unintended Movement
IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL SHOULDER REPLACEMENT ON (B)(6) 2024. WHILE INSERTING THE REAMER GUIDE, SOMETHING IN THE REAMER GUIDE INSERTER BROKE AND THE GUIDE WOULD WOBBLE BACK AND FORTH. STAFF REMOVED REAMER GUIDE BY HAND. THERE WAS NO SIGNIFICANT DELAY. NOTHING WAS LEFT INSIDE OF THE PATIENT AND NO HARM WAS CAUSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20636278 ↗MalfunctionOct 28, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT PRIOR TO THE CASE BEGINNING, BEFORE THE PATIENT WAS BROUGHT BACK TO THE OR IT WAS DISCOVERED THAT THE 145 DEGREE REAMER GUIDE INSERTER DID NOT RETAIN THE REAMER EPI GUIDE SUFFICIENTLY. A SECOND SET WAS OPENED FOR THE REPLACEMENT. THIS DID NOT IMPACT THE DURATION OF THE CASE AND THERE WAS IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20544539 ↗MalfunctionOct 11, 2024Unintended Movement; Unintended Movement
IT WAS REPORTED DURING A SHOULDER REPAIR ON (B)(6) 2024 THAT INSTRUMENT BECAME LOOSE WHEN TRYING TO CAPTURE THE EPI REAMER GUIDE.
Patient problems: Insufficient Information
MAUDE report 20428726 ↗MalfunctionMay 28, 2024Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE EPI 145 REAMER HANDLE IS LOOSE.
Patient problems: Insufficient Information
MAUDE report 19404723 ↗MalfunctionMay 28, 2024Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE EPI STEM GUIDE INSERTER WAS LOOSE.
Patient problems: Insufficient Information
MAUDE report 19404635 ↗MalfunctionMar 15, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE145 RSA REAMER GUIDE HANDLE WAS LOOSE AND CAUSED DELAYS INTR-OP TO MAKE ATTEMPTS TO ENSURE PROPER CONTACT AND TECHNIQUE OF REAMER PLACEMENT WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES, IF YES, NUMBER OF MINUTES: 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18911472 ↗MalfunctionFeb 8, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE HANDLE TO BROACH CONNECTION APPEARS TO BE WORN SO WOULD NOT TIGHTEN COMPLETELY. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18669582 ↗
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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