ENDOBUTTON 72203331Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885554028546), received between Jul 28, 2020 and Nov 23, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (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. 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.

• InjuryNov 23, 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 15849991 ↗
• MalfunctionSep 7, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING SURGERY, THE THREADS OF THE ENDOBUTTON WERE FOUND TO BE TORN; THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10499558 ↗
• MalfunctionJul 28, 2020Material Frayed; Material Frayed

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, WHEN THE ENDOBUTTON CONTINUOUS LOOP WAS REMOVED FROM THE PACKET, IT WAS FOUND THAT IT WAS ALREADY FRAYED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10335522 ↗