HEALIX ADVANCE DYNATAPE DYNACORD 280735Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886705031016), received between Apr 29, 2022 and Apr 6, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Difficult to Advance

  IT WAS REPORTED THAT DURING ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE THAT THE 4.5 HLX ADV BR 2.5 DYNAT BLK ANCHOR DEVICE COULD NOT BE INSERTED BECAUSE IT DID NOT ROTATE PROPERLY DURING INSERTION. 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 24794593 ↗
• MalfunctionMay 16, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE FOR A SHOULDER ROTATOR CUFF TEAR, THE 4.5 HLX ADV BR 2.5 DYNAT BLK DEVICE WAS USED AS THE MEDIAL ANCHOR. HOWEVER, WHEN ATTEMPTING TO INSERT THE ANCHOR, THE THREADS OF THE INSERTER AND THE ANCHOR DID NOT MESH WELL, MAKING IT UNUSABLE. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22036053 ↗
• MalfunctionMar 24, 2025Crack; Crack

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF TEAR SURGICAL PROCEDURE, WHEN THE SURGEON INSERTED THE 4.5 HLX ADV BR 2.5 DYNAT BLK ANCHOR DEVICE INTO THE PATIENT¿S BODY UNDER AN ARTHROSCOPE, HE FOUND THAT THE DEVICE HAD CRACKED. IT WAS REPORTED THAT THE DEFECTIVE DEVICE WAS REMOVED IMMEDIATELY. ANOTHER DEVICE WAS USED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT, OR SURGICAL DELAY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21680393 ↗
• MalfunctionOct 26, 2023Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING A SHOULDER SCOPE PROCEDURE ON (B)(6) 2023 WHILE USING THE 4.5 HLX ADV BR 2.5 DYNAT BLK DEVICE THE SURGEON PUNCHED THE HOLE FOR 4.5 MM HEALIX ADVANCE TM BR ANCHOR WITH (1) 2.5 MM DYNATAPE TM IN BLACK/BLUE AND (1) #2 DYNACORD TM IN WHITE/BLUE/GREEN, WITH UTILITY SHUTTLE SUTURE, NO NEEDLES AND THE TIP OF THE ANCHOR BROKE EVEN THOUGH THE SURGEON SUGGESTED THE BONE WAS NOT HARD. NEW ANCHOR WAS OPENED AND IT WAS IMPLANTED SUCCESSFULLY. NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18011699 ↗
• MalfunctionJul 26, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ARTHROSCOPIC SHOULDER ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE INTERNAL PART OF THE 4.5 MM HEALIX ADVANCE TM BR ANCHOR WITH (1) 2.5 MM DYNATAPE TM IN BLACK/BLUE AND (1) #2 DYNACORD TM IN WHITE/BLUE/GREEN, WITH UTILITY SHUTTLE SUTURE, NO NEEDLES DEVICE THAT HELD THE SUTURES BROKE AFTER PASSING THE SUTURES AND TYING OVER THE CUFF. ACCORDING TO THE REPORT, THE ANCHOR BODY REMAINED LODGED IN THE HUMERAL HEAD WHILE THE SUTURES REMAINED IN THE CUFF. 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 17399319 ↗
• MalfunctionJul 10, 2023Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE OF THE LEFT SHOULDER ON (B)(6) 2023, IT WAS OBSERVED THAT THE 4.5 HLX ADV BR 2.5 DYNAT BLK DEVICE BROKE OFF. REMOVED ALL THE BROKEN PARTS. 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 17289296 ↗
• MalfunctionAug 1, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6)2022, IT WAS OBSERVED THAT, THE SUTURE ON THE 4.5 MM HEALIX ADVANCE TM BR ANCHOR WITH (1) 2.5 MM DYNATAPE TM IN BLACK/BLUE AND (1) #2 DYNACORD TM IN WHITE/BLUE/GREEN, WITH UTILITY SHUTTLE SUTURE, NO NEEDLES BROKE UPON TENSIONING. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15139216 ↗
• InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THROUGH CLINICAL RESEARCH REPORT FOR CLINICAL EVIDENCE ON SAFETY AND PERFORMANCE OF THE HEALIX ADVANCE BR WITH DYNATAPE DEVICE THAT POSTOPERATIVELY TO A ROTATOR CUFF REPAIR PROCEDURE PERFORMED ON (B)(6) 2021, THE PATIENT HAD A REVISION PROCEDURE ON (B)(6) 2021 DUE TO A RECURRENT TEAR LIKELY SECONDARY TO SMOKING AND NONCOMPLIANCE. ACCORDING TO THE REPORT, THE PATIENT HAD A POSTOPERATIVE PAIN AND RE-TEAR ON (B)(6) 2021. THE STATUS OF THE PATIENT POSTOPERATIVELY WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) 4.5 HLX ADV BR 2.5 DYNAT BLK DEVICE. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14252884 ↗