DELTA XTEND 2307-87-002Recalls & reported problems
Depuy (Ireland) · DELTA Xtend METAGLENE HOLDER 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 internal rod is part of a surgical impactor holder used during shoulder replacement procedures. The 63 reports mostly describe the instrument not fitting or holding together properly during surgery — parts breaking, bending, cross-threading, or not connecting to other components, sometimes delaying the operation. No deaths and no injuries were reported, and 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
- 63
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 10603295116431), received between Jul 31, 2017 and Sep 16, 2026 — classified as 63 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (36 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
- Device-Device Incompatibility36
- Material Twisted/Bent12
- Naturally Worn9
- Break8
- Material Deformation7
- Material Integrity Problem3
- Unintended Movement3
- Accessory Incompatible1
Patient problems
- No Clinical Signs, Symptoms or Conditions34
- No Consequences Or Impact To Patient18
- Insufficient Information9
- No Code Available4
- No Information1
- Not Applicable1
Recent adverse event reports
The 25 most recent of 63 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794917 ↗MalfunctionJun 8, 2026Material Deformation
IT WAS REPORTED THAT DURING A SHOULDER REPAIR SURGERY, THE GREEN DISK WAS BROKEN AND THROWN AWAY AFTER THE CASE. THE BLUE HANDLE SCREWDRIVER WAS STRIPPED. THE HUMERAL CUPS WERE ALSO BROKEN AND THROWN AWAY AFTER THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25429352 ↗MalfunctionJun 8, 2026Material Deformation
IT WAS REPORTED THAT DURING A SHOULDER REPAIR SURGERY, THE GREEN DISK WAS BROKEN AND THROWN AWAY AFTER THE CASE. THE BLUE HANDLE SCREWDRIVER WAS STRIPPED. THE HUMERAL CUPS WERE ALSO BROKEN AND THROWN AWAY AFTER THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25428238 ↗MalfunctionJun 1, 2026Device-Device Incompatibility
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE METAGLENE INNER COMPONENT COULD NOT BE PROPERLY SCREWED INTO THE HANDLE. CONSEQUENTLY, NEITHER THE TEMPLATE NOR, SUBSEQUENTLY, THE METAGLENE IMPLANT ITSELF COULD BE SECURED FOR PROPER POSITIONING AND IMPLANTATION. THIS RESULTED IN DELAYS TO THE SURGICAL PROCEDURE, THOUGH IT CAUSED NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25350791 ↗MalfunctionFeb 5, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE BLUE HANDLE WOULD NOT HOLD THE METAGLENE OR IMPLANT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24272551 ↗MalfunctionFeb 5, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE HANDLE WILL NOT HOLD ON OR CONNECT CORRECTLY WITH METAGLENE GUIDE OR METAGLENE IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24270628 ↗MalfunctionDec 11, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THIS DURING A REVERSE SHOULDER ARTHROPLASTY (RSA) PERFORMED, THE USER ATTEMPTED TO ATTACH THE METAGLENE POSITIONING PLATE TO THE METAGLENE HOLDER, BUT IT DID NOT FIT THROUGH THE HOLE IN THE PLATE AND COULD NOT BE USED. IT WAS NOTED THAT ADDITIONAL ATTEMPTS WERE MADE TO FIT THE PLATE AND HOLDER BUT WERE UNABLE TO GET IT INTO THE HOLE IN THE PLATE. THEREFORE, IT WAS NOT POSSIBLE TO FIX THE METAGLENE. USING THE HOSPITAL'S EQUIPMENT, THE SURGEON MANAGED TO PLACE THE GUIDE PIN AND INSERT THE METAGLENE, COMPLETING THE SURGERY. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23783943 ↗MalfunctionDec 8, 2025Material Deformation; Material Deformation
CROSS THREADED. NOT USEABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23744951 ↗MalfunctionNov 5, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE MOUNTING FOR THE METAGLENE DOES NOT REALLY WORK ANYMORE, ALTHOUGH THEY GOT COMPLETELY NEW SIEVES ABOUT 6 MONTHS AGO. IT NO LONGER GRIPS THE BASE PLATE AND IT CONSTANTLY DROPS OFF, INCLUDING THE IMPLANT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23480597 ↗MalfunctionJun 23, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS DISCOVERED BEFORE THE CASE THAT THE METAGLENE HOLDER WAS BROKEN. ANOTHER METAGLENE HOLDER WAS LOCATED AND USED. THERE WAS NO NEGATIVE IMPACT TO THE CASE, NOR WAS THERE A DELAY. UPON VISUAL EXAMINATION OF THE DEVICE, THE MANUFACTURER NOTICED THAT THE SHAFT HAS FALLEN AND IS APART STILL ATTACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22307870 ↗MalfunctionMay 23, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE RIGHT REVERSE TSA, AFTER CASE IT WAS NOTED THE HANDLE CAME OFF THE TIGHTENING ROD. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22080390 ↗MalfunctionMay 17, 2025Break; Break
IT WAS REPORTED THAT BEFORE THE CASE THAT THE METAGLENE HOLDER WAS BROKEN. ANOTHER METAGLENE HOLDER WAS LOCATED AND USED. THERE WAS NO NEGATIVE IMPACT TO THE CASE, NOR WAS THERE A DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22041137 ↗MalfunctionMay 1, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT SCREW DRIVER WILL NOT THREAD ONTO BASEPLATE.
Patient problems: Insufficient Information
MAUDE report 21945833 ↗MalfunctionMay 1, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT SCREW DRIVER WILL NOT THREAD ONTO BASEPLATE.
Patient problems: Insufficient Information
MAUDE report 21945832 ↗MalfunctionFeb 20, 2025Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT INTRAOPERATIVELY THERE WERE DIFFICULTIES ATTACHING THE METAGLENE TEMPLATE WITH THE INSTRUMENT´S BLUE HANDLE. IT KEPT COMING LOOSE. THERE WAS NO SURGICAL DELAY, AND NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21423189 ↗MalfunctionJan 3, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE HANDLE IS BROKEN AND WILL NOT CONNECT TO GUIDE. UNKNOWN SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 21066840 ↗MalfunctionOct 15, 2024Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT THE SURGEON WAS DOING A DELTA XTEND REVERSE SHOULDER REPLACEMENT TODAY AND REPORTED THAT THE METAGLENE HOLDER AND METAGLENE HOLDER INTERNAL ROD WERE NOT HOLDING THE METAGLENE GUIDE PLATE EFFECTIVELY AS IT WAS LOOSE. ALSO THE SIZE 38 GLENOSPHERE TRIAL WAS DAMAGED BY INSTRUMENTS AND MISUSE. THE PLASTIC WAS SCRATCHED AND SHREDDED ON THE INNER ASPECT OF THE GLENOSPHERE. THERE WAS MINIMAL DELAY TO THE SURGERY WHILST REATTACHING METAGLENE PLATE. THERE WAS NO KNOW PATIENT ADVERSE EFFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20451603 ↗MalfunctionAug 15, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE METAGLENE HOLDER IS DAMAGED. METAL SLEEVE ON TOP OF DEVICE LOOSE AND INTERNAL THREADS DAMAGED. ALSO, THE METAGLENE HOLDER INTERNAL ROD, THREADS DAMAGED FROM USE WITH THE METAGLENE HOLDER. SURGERY WAS DELAYED 5 MINUTES DUE TO THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19991354 ↗MalfunctionFeb 12, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORED THAT THE METAGLENE HOLDER (2307-87-005) AND INTERNAL ROD (2307-87-002) WERE NO LONGER EFFECTIVELY GRASPING THE METAGLENE DUE TO WEAR AND TEAR . NO DELAY TO SURGERY
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18692114 ↗MalfunctionSep 15, 2023Improper or Incorrect Procedure or Method; Material Integrity Problem; Improper or Incorrect Procedure or Method; Material Integrity Problem
IT WAS REPORTED THAT THE NURSE DID NOT TIGHTEN BLUE HANDLE ENOUGH TO SECURE METAGLENE VIA HEX CONNECTION AND IMPLANT WAS DROPPED. SURGEON OVER TIGHTENED BLUE HANDLE . THIS CAUSED OVER EXPANSION OF HEX HEAD AND DAMAGED THE TOP OF INTERNAL EXPANDER ROD. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES. IF YES, NUMBER OF MINUTES: 5 MINS. ACTION TAKEN WHEN EVENT OCCURRED? SECOND IMPLANT PROVIDED AND IMPACTED WITH CONVEX IMPACTOR TIP. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? NO. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES. 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 HOSPITAL CSD. (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: Insufficient Information
MAUDE report 17754620 ↗MalfunctionMar 15, 2023Break; Break
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE INSTRUMENT WAS NOT USED DURING A SURGERY. THERE WERE NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16545189 ↗MalfunctionFeb 24, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT METAGLENE ROD IS STRIPPED. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16436528 ↗MalfunctionOct 13, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING A REVERSE SHOULDER ARTHROPLASTY THE METAGLENE HOLDER WOULD NOT CONNECT TO THE METAGLENE FOR IMPLANTATION. THE OTHER SET WAS OPENED AND THE OTHER METAGLENE HOLDER WAS OPENED. REQUESTED BOTH HOLDERS BE REPLACED. THERE WAS A SURGICAL DELAY OF 10 MINUTES.
Patient problems: Insufficient Information
MAUDE report 15597074 ↗MalfunctionOct 13, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING A REVERSE SHOULDER ARTHROPLASTY THE METAGLENE HOLDER WOULD NOT CONNECT TO THE METAGLENE FOR IMPLANTATION. THE OTHER SET WAS OPENED AND THE OTHER METAGLENE HOLDER WAS OPENED. REQUESTED BOTH HOLDERS BE REPLACED. THERE WAS A SURGICAL DELAY OF 10 MINUTES.
Patient problems: Insufficient Information
MAUDE report 15597070 ↗MalfunctionOct 11, 2022Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem
IT WAS REPORTED THAT THE INTERNAL ROD WAS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15580155 ↗
Other IMPACTOR devices
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- ATTUNE 2544-01-006Depuy (Ireland) · IMPACTOR1 recall2,539 reports
- ATTUNE 2544-01-003Depuy (Ireland) · IMPACTOR1 recall1,498 reports
- ATTUNE 2544-01-017Depuy (Ireland) · IMPACTOR1 recall1,456 reports
- ATTUNE 2544-01-004Depuy (Ireland) · IMPACTOR1 recall875 reports
- DURALOC 2360-71-000Depuy Orthopaedics, Inc. · IMPACTOR716 reports
- SPECIALIST 2581-11-000Depuy (Ireland) · IMPACTOR704 reports
- INHANCE 6205-10-103Depuy (Ireland) · IMPACTOR337 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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