ENDOBUTTON 013186Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010024763), received between Nov 29, 2022 and May 3, 2023 — classified as 3 injuries.

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 16, 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.

• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A DISTAL BICEPSUSING AN ENDOBUTTON DEVICE, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS TREATED BY AN ADDITIONAL SURGERY. THE CURRENT HEALTH STATUS OF PATIENT IS ALSO UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 16864633 ↗
• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A DISTAL BICEPS SURGERY USING AN ENDOBUTTON DEVICE, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS TREATED BY AN ADDITIONAL SURGERY. THE CURRENT HEALTH STATUS OF PATIENT IS ALSO UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 16864240 ↗
• InjuryNov 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON REGISTRY REVIEW 2021 NEW ZEALAND ACL REGISTRY IMPLANT REPORT, ONE PATIENT REQUIRED A REVISION SURGERY AFTER AN ACL PROCEDURE USING ONE(1) ENDOBUTTON DEVICE. IT IS UNKNOWN HOW WAS THE EVENT TREATED/RESOLVED. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15880329 ↗