GRAFTMASTER 014415Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010397362), received between Dec 6, 2017 and Jul 16, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 18, 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.

• MalfunctionJul 16, 2020Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE SCALING ON THE ENDO BUTTON HOLDER IS DRAWN IN INCORRECTLY. THE MALFUNCTION HAPPENED BEFORE THE PROCEDURE AND WAS SOLVED WITH A DELAY SHORTER THAN 30 MINUTES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10286473 ↗
• MalfunctionDec 6, 2017Product Quality Problem; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE MEASURING SCALE IS NOT ACCURATE, +3 TO 4MM. THEREFORE THE GRAFT (BTB) WAS TO LONG AND HAS TO BE SHORTENED INTRAOPERATIVELY. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7087595 ↗