HEALIX ADVANCE ORTHOCORD 222319Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705021475), received between Jul 19, 2018 and Mar 19, 2025 — classified as 2 malfunctions.

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

• MalfunctionMar 19, 2025Crack; Crack

  IT WAS REPORTED THAT THE 4.5MM HEALIX ADVANCE BR MULTIPACK - 2 SUTURE DEVICE WAS SLIGHTLY CRACKED. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21641026 ↗
• MalfunctionJul 19, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT ONE OF HIS 4.5MM HEALIX ADVANCE ANCHORS BROKE IN HALF UPON INSERTION DURING A ROTATOR CUFF PROCEDURE. THE SURGEON REMOVED ALL BROKEN PIECES FROM THE PATIENT AND INSERTED ANOTHER ANCHOR INTO THE SAME BONE HOLE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE DEVICE WAS DISCARDED. IT WAS GOOD BONE QUALITY AND THE PATIENT WAS A MALE IN HIS THIRTIES. 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 7703005 ↗