DELTA XTEND 2307-74-012Recalls & reported problems
Depuy (Ireland) · DELTA Xtend PROXIMAL REAMING GUIDE DIA 12 MM · Class 1
All models of DELTA XTEND (194)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295116165), received between Aug 3, 2017 and Jan 24, 2024 — classified as 2 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Connection Problem” (2 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
- Connection Problem2
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Device-Device Incompatibility1
- Material Deformation1
- Mechanical Jam1
Patient problems
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient2
- Not Applicable2
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
- No Information1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 24, 2024Material Deformation; Material Deformation
ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18569533 ↗MalfunctionFeb 4, 2021Mechanical Jam; Mechanical Jam
INITIAL REPORT: VERY SCLEROTIC BONE REP PRESENT AND FOLLOWED STANDARD SURGICAL TECHNIQUE INSTRUMENTS DAMAGED UPON USE SURGICAL DELAY 5 MINUTES. PROCEDURE SUCCESSFULLY COMPLETED. NO CONSEQUENCE TO PATIENT. FURTHER INFORMATION PROVIDED; THE AWL WAS BENT. THE TIP OF THE PROXIMAL REAMING HANDLE SNAPPED OFF. THE PROXIMAL REAMING GUIDE WAS DAMAGED UPON REMOVAL AS WAS STUCK IN THE PATIENT AFTER THE PROXIMAL REAMING HANDLE SNAPPED. HAD TO REMOVE WITH MOLE WRENCH / PLIERS AND ROUGHED UP THE ENDS.
Patient problems: Insufficient Information
MAUDE report 11279301 ↗MalfunctionSep 16, 2020Break; Break
IT WAS REPORTED THAT THE HEAD OF THE PROXIMAL REAMING GUIDE INTERNAL ROD BROKE OFF DURING IMPACTION, THE PROXIMAL REAMING GUIDE 12MM WAS ATTACHED TO THE REAMING GUIDE AND INTERNAL ROD WHEN IT BROKE, AND THE ASSEMBLY CANNOT BE DISASSEMBLED. TWO OF THE MATING SPIKES ON THE LOCKING SCREWDRIVER BROKE DURING SCREW INSERTION.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10540766 ↗MalfunctionAug 24, 2018Device-Device Incompatibility; Device-Device Incompatibility
INABILITY TO DISASSEMBLE MATING DEVICES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7813802 ↗InjuryMay 18, 2018Connection Problem; Connection Problem
IT WAS REPORTED THAT PROX REAMING GUIDE (B)(4) STUCK IN HUMERUS. HOLDER (B)(4) WOULD NOT REMOVE GUIDE. DOCTOR DID A OSTEOTOME WHICH ALLOWED GUIDE TO BE REMOVED. AFTER OSTEOTOME, HOLDER WAS REATTACHED TO GUIDE FOR REMOVAL.
Patient problems: No Known Impact Or Consequence To Patient; Not Applicable
MAUDE report 7525158 ↗InjuryMay 17, 2018Connection Problem; Connection Problem
IT WAS REPORTED THAT PROX REAMING GUIDE 2307-74-012 STUCK IN HUMERUS. HOLDER 2307-74-001 WOULD NOT REMOVE GUIDE. DOCTOR DID A OSTEOTOME WHICH ALLOWED GUIDE TO BE REMOVED. AFTER OSTEOTOME, HOLDER WAS REATTACHED TO GUIDE FOR REMOVAL.
Patient problems: No Known Impact Or Consequence To Patient; Not Applicable
MAUDE report 7523876 ↗MalfunctionAug 3, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THIS HAD METAL SHAVINGS THAT PROHIBITED IT FROM FITTING AND PROPERLY BEING REMOVED FROM THE IMPACT HANDLE.
Patient problems: No Information
MAUDE report 6764493 ↗
Other TEMPLATE devices
- ATTUNE 2544-01-014Depuy (Ireland) · TEMPLATE802 reports
- ATTUNE 2545-00-546Depuy (Ireland) · TEMPLATE1 recall301 reports
- ARTICUL/EZE 2531-51-000Depuy (Ireland) · TEMPLATE323 reports
- DELTA XTEND 2307-95-000Depuy (Ireland) · TEMPLATE315 reports
- ATTUNE 2545-00-547Depuy (Ireland) · TEMPLATE1 recall231 reports
- ATTUNE 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 reports
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 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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