HEALIX TI ANCHOR w/DYNACORD 222051Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705029914), received between May 10, 2022 and May 10, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionMay 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE WHITE HANDLE CAME OFF OF THE METAL PART OF THE INSERTER ON THE 4.5 HEALIX TI ANC-DYNA STR/BL DEVICE WHILE TRYING TO REMOVE THE INSERTER FROM THE PATIENT AFTER THE SURGEON PLACED THE ANCHOR. ACCORDING TO THE REPORT, THE SURGEON WAS ABLE TO USE A PLIER-LIKE INSTRUMENT TO REMOVE THE METAL SHAFT THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14348153 ↗