ENDURANCE 2521-01-510Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295127871), received between Dec 2, 2020 and Aug 28, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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.

Most reported problems

Recent adverse event reports

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

• MalfunctionAug 28, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SZ 1 REPLACEMENT BROACHES ARRIVED AND WERE A DIFFERENT DESIGN. NECK SEGMENTS WERE TOO LOOSE ON THE NEW BROACHES. UNKNOWN SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17634305 ↗
• MalfunctionAug 22, 2023Device-Device Incompatibility; Material Deformation; Unintended Movement; Device-Device Incompatibility; Material Deformation; Unintended Movement

  IT WAS REPORTED THAT THE SIZE 1 ENDURANCE BROACH HAS BEEN WARPED SO THAT IT IS LOOSE AND UNSTABLE IN THE BROACH HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17595895 ↗
• MalfunctionDec 2, 2020Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE BROACHES ARE DULL AND NEED REPLACING. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10931343 ↗