ENDOBUTTON 72202544Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010651556), received between Dec 4, 2020 and Apr 26, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 26, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT, DURING AN ACL SURGERY, IT WAS NOTICED THE SCALE ON "ENDOBUTTON INDICATOR ASSEMBLY" WAS PRINTED ON THE WRONG SIDE AND THEREFORE, IT WAS NOT POSSIBLE TO VIEW THE SIZE THROUGH THE INSTRUMENT WINDOW. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING THE SAME FAULTY DEVICE ESTIMATING THE FEMORAL TUNNEL. NO PATIENT INJURIES 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11726695 ↗
• MalfunctionDec 4, 2020Manufacturing, Packaging or Shipping Problem; Component Misassembled; Manufacturing, Packaging or Shipping Problem; Component Misassembled

  IT WAS REPORTED THAT DURING LIGAMENTOPLASTY, THE SCREW THAT ALLOWS THE MEASUREMENT SCALE TO BE PLACED ON THE METER BODY WAS PLACED BACKWARDS IN THE MANUFACTURING PROCESS, WHICH MAKES IT IMPOSSIBLE TO MEASURE THE LENGTH OF THE FEMORAL TUNNEL WHEN PREPARING IT IN THE SURGICAL PROCEDURE. THERE WAS A CHANGE IN SURGICAL TECHNIQUE AND NO SIGNIFICANT DELAY 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: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10947411 ↗