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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 1 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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 ↗

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Sources and updates

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