HEALIX ADVANCE DYNATAPE DYNACORD 280717Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886705031047), received between Mar 31, 2022 and Feb 20, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Crack” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2026Material Deformation

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE THAT THE 4.5 HLX ADV PK 2.5 DYNAT WHAT ANCHOR DEVICE INSERTER WAS STRIPPED INSIDE THE IMPLANT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24405542 ↗
• InjuryMar 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THROUGH CLINICAL TRIAL THAT POSTOPERATIVELY TO A ROTATOR CUFF REPAIR PROCEDURE ON THE RIGHT SHOULDER INITIALLY PERFORMED ON (B)(6) 2022 USING A HEALIX ADVANCE DYNATAPE DYNACORD, A PATIENT HAD A REOPERATION PROCEDURE ON (B)(6) 2022 DUE TO JOINT STIFFNESS.

  Patient problems: Loss of Range of Motion

  MAUDE report 16472221 ↗
• MalfunctionAug 25, 2022Crack; Crack

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE TIP ON THE ANCHOR ON THE 4.5 HLX ADV PK 2.5 DYNAT WHT DEVICE WAS CRACKED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 15297074 ↗
• InjuryMar 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THROUGH A REVIEW OF A CLINICAL RESEARCH REPORT FOR CLINICAL EVIDENCE ON SAFETY AND PERFORMANCE OF 4.5 HLX ADV PK 2.5 DYNAT WHT DEVICE THAT POSTOPERATIVELY TO A ROTATOR CUFF REPAIR PROCEDURE PERFORMED ON AN UNKNOWN DATE IN 2020, A PATIENT HAD AN INFECTION 50 DAYS AFTER THE INITIAL PROCEDURE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 13969171 ↗