ENDOBUTTON 72202799Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010657626), received between Nov 13, 2017 and Nov 13, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. How this data works · Data updated Oct 13, 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.

• InjuryNov 13, 2023Break; Break

  IT WAS REPORTED THAT DURING ACL RECONSTRUCTION SURGERY, THE ENDOBUTTON ULTRA´S GUIDE PIN BROKE OFF INSIDE PATIENT´S BONE. THE BROKEN PIECES WERE LEFT INSIDE THE PATIENT. IT IS UNKNOWN IF THERE WAS A BACK UP DEVICE AVAILABLE OR IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18120992 ↗
• MalfunctionFeb 13, 2018Break; Detachment Of Device Component

  IT WAS REPORTED THAT THE 2.7 PIN BROKE OFF IN THE PATIENT AT THE 75 MARK, THE PIN WAS RETRIEVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7267111 ↗
• MalfunctionNov 13, 2017Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHILE USING THE ENDOBUTTON THE 1.2 MM WIRE BROKE OFF INTO THE PATIENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7024778 ↗