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DELTA XTEND 2307-01-030Recalls & reported problems

Depuy (Ireland) · DELTA Xtend BROACH HANDLE · Class 1

All models of DELTA XTEND (194)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295115502), received between Jun 16, 2020 and Dec 22, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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.

Most reported problems

Device problems

  • Break1
  • Device-Device Incompatibility1
  • Unintended Movement1

Patient problems

  • Insufficient Information1
  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 22, 2021Unintended Movement; Unintended Movement

    IT WAS REPORTED THAT THIS WAS AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2021. EVERY TIME THEY USED THE HANDLE, THE ¿BALL JOINT¿ WHERE THE 230701031 GONIOMETER IS MOUNTED HAD COME LOOSER. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. [ANSWER TO PCF] WITH REGARDS TO THIS, PLEASE CONFIRM IF ANY OF THE FOLLOWING INFORMATION IS AVAILABLE: PLEASE PROVIDE VALID LOT NUMBER FOR DELTAXTEND BROACH HANDLE (230701030).: LOT # 5335312/ SERIAL # (B)(4). PLEASE VERIFY IF THE PRODUCT IS AVAILABLE FOR RETURN OR NOT? THE DEVICE CURRENTLY IN OUR HANDS WILL BE RETURNED TO YOU.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13061318 ↗
  • MalfunctionAug 20, 2021Device-Device Incompatibility; Device-Device Incompatibility

    DURING GLOBAL ANATOMIC TSR IT WAS DISCOVERED THAT THE SIZE 48 GLENOID TRIAL HAD A LARGE CRACK THROUGH IT. FURTHERMORE THE TRIAL STEM INTRODUCER FAILED TO ENGAGE WITH THE NECK COMPONENTS DESPITE ATTEMPTS TO MANIPULATE IT DURING AND AFTER THE CASE.

    Patient problems: Insufficient Information

    MAUDE report 12348312 ↗
  • MalfunctionJun 16, 2020Break; Break

    IT WAS REPORTED THAT THE BROACH HANDLE WAS BROKEN DURING SURGERY. NO SURGICAL DELAY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10158076 ↗

Other BROACH devices

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Sources and updates

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