NA 232.009Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982159724), received between Aug 21, 2018 and Aug 21, 2018 — classified as 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2018Material Frayed; Material Frayed

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR SURGICAL PROCEDURE, AFTER THE SURGEON PULLED THE GRAFT INTO THE TUNNEL, HE NEEDED TO USE THE GREEN SUTURE ON HIS RIGID LOOP ANCHOR TO ADVANCE THE GRAFT WHEN THE SUTURE BROKE. THE SURGEON THEN PULLED THE GRAFT OUT OF THE TUNNEL, AND USED A COMPETITOR'S BUTTON TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES. GRAFT HOLE WAS PREPPED CORRECTLY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7801205 ↗