HEALIX ADVANCE DYNATAPE DYNACORD 280729Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886705031030), received between Mar 31, 2022 and Nov 20, 2024 — 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.

• MalfunctionNov 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROXIMAL HAMSTRING REPAIR SURGICAL PROCEDURE, THE FOUR 4.5 HLX ADV PK 2.5 DYNAT BLK DEVICES WERE BEING INSERTED INTO THE BONE. AS THE SURGEON WAS PASSING THE DYNATAPE SUTURE TO THE TENDON THE DYNATAPE DEVICE FELL OUT OF THE ANCHOR. THE ANCHOR ALSO LEFT IMPACT IN THE BONE AND DID NOT BREAK. ANOTHER DYNATAPE SUTURE ALSO IMPACTED ON THE ANCHOR. THE ANCHOR WAS STILL SUCCESSFULLY FIXATED WITH THE DYNACORD SUTURE STILL IN THE ANCHOR. IT WAS THE DYNATAPE THAT FAILED. THERE WAS AN UNSPECIFIED SURGICAL DELAY HOWEVER IT WAS NOT DUE TO THE ANCHOR. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20736984 ↗
• MalfunctionMay 23, 2023Crack; Crack

  IT WAS REPORTED BY THE SALES REP THAT DURING A LATERAL ANKLE STABILZATION PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE DISTAL TIP ON THE HEALIX ADVANCE PEEK ANCHOR W/ DYNATAPE SUTURE WITH (1) 2.5MM BLACK/BLUE DEVICE CRACKED UPON INSERTION. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. 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 16987309 ↗
• 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 BLK DEVICE THAT POSTOPERATIVELY TO A ROTATOR CUFF REPAIR PROCEDURE PERFORMED ON AN UNKNOWN DATE IN 2020, A PATIENT HAD A REVISION 49 DAYS AFTER THE INITIAL PROCEDURE THAT INCLUDED IRRIGATION, DEBRIDEMENT, AND REMOVAL OF HARDWARE DUE TO POSTOPERATIVE INFECTION IN THE RIGHT SHOULDER. ACCORDING TO THE REPORT, THE PATIENT HAD THE INFECTION 38 DAYS AFTER THE INITIAL PROCEDURE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Loss of Range of Motion; Unspecified Tissue Injury

  MAUDE report 13970584 ↗
• 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 BLK 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 13969268 ↗