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DELTA XTEND 2307-01-031Recalls & reported problems

Depuy (Ireland) · DELTA Xtend GONIOMETER · Class 1

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295115519), received between Feb 23, 2022 and Jun 24, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Device-Device Incompatibility1
  • Mechanical Jam1
  • Unintended Movement1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 24, 2022Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

    IT WAS REPORTED THAT BALL BEARING IS STUCK CAUSING INSTRUMENT TO NOT LATCH ONTO HANDLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14799511 ↗
  • MalfunctionFeb 23, 2022Unintended 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.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13583601 ↗

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.