ENDOBUTTON 72200148Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010597274), received between Oct 2, 2018 and Nov 22, 2022 — classified as 2 injuries, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 22, 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, AN UNKNOWN AMOUNT OF PATIENTS REQUIRED A REVISION SURGERY AFTER AN ACL PROCEDURE USING ENDOBUTTON DEVICES. PATIENTS OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15848450 ↗
• MalfunctionSep 25, 2020Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE ENDOBUTTON'S THICK ROPE STARTED TO FLUFF AND COULD NOT LONGER BE USED. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS A PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10589622 ↗
• InjuryJan 10, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER A DISLOCATION OF THE RIGHT ACROMIOCLAVICULAR USING AN ENDOBUTTON, THE WOUND WAS FOUND OOZING AND NOT HEALING. THE PATIENT OUTCOME IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Unspecified Infection

  MAUDE report 9575117 ↗
• MalfunctionJun 11, 2019Break

  IT WAS REPORTED THAT DURING A PROCEDURE, WHEN THE ENDOBUTTON ATTACHED TO THE GRAFT WAS INSERTED INTO THE FEMORAL, AND SURGEON PULLED THREAD, ULTRABRAID X5 WAS BROKEN. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO SIGNIFICANT DELAY OR PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8689007 ↗
• MalfunctionOct 2, 2018Component Missing

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE PACKAGE WAS OPENED, IT WAS FOUND THAT ONE STERILE PACKAGE WAS MISSING. NO PATIENT INJURIES WERE REPORTED. PROCEDURE WAS COMPLETED WITH THE SAME DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7928434 ↗