HEALIX TI 3 SUTURE ANCHOR w/DYNACORD 222056Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705029952), received between Feb 25, 2025 and Feb 25, 2025 — classified as 1 malfunction.

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

• MalfunctionFeb 25, 2025Break; Break

  IT WAS REPORTED THAT DURING ROTATOR CUFF REPAIR PROCEDURE, WHILE THE 5.5 HEALIX TI ANCHOR WITH DYNACORD 3-SUT DEVICE WAS INSERTED IT WAS OBSERVED THAT THE SHAFT BROKE, LEAVING THE IMPLANT 50% PROUD OF THE CORTICAL LAYER OF BONE. ACCORDING TO THE REPORTER, THE DOCTOR ATTEMPTED TO REMOVE THE IMPLANT USING THE BROKEN SHAFT AND A SCREW REMOVAL KIT BUT WAS UNABLE. IT WAS REPORTED THAT REMOVAL WAS SUCCESSFUL BY USING A FREER AROUND THE IMPLANT, RESULTING IN BONE LOSS OF THE PATIENT. A DIFFERENT HEALIX TI SIZE WAS USED TO COMPLETE THE REPAIR. THERE WAS A FIFTEEN MINUTE DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21456826 ↗