HEALIX ADVANCE DYNATAPE DYNACORD 280723Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886705031023), received between Feb 25, 2022 and Sep 5, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT AFTER CREATING A BONE HOLE WITH AN AWL, THE ANCHOR ON THE 4.5 HLX ADV BR 2.5 DYNAT WHT DEVICE WAS INSERTED, BUT THE ANCHOR BROKE. THE REPORTER INDICATED THAT IT WAS POSSIBLE THAT THE PATIENT'S BONE WAS TOO HARD, BUT SINCE THE SUBSEQUENT ANCHOR DID NOT BREAK, A PRODUCT ISSUE WAS SUSPECTED. 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 22983252 ↗
• MalfunctionDec 2, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON THE RIGHT SHOULDER FOR A SHOULDER ROTATOR CUFF TEAR, IT WAS DISCOVERED THAT THE ANCHOR ON THE 4.5 HLX ADV BR 2.5 DYNAT WHT DEVICE BROKE. IT WAS REPORTED THAT THE SURGEON ATTEMPTED TO INSERT THE DEVICE AFTER CREATING THE BONE HOLE BUT DISCONTINUED ITS USE WHEN THE ANCHOR PORTION BROKE IN A SPIRAL SHAPE. NO FRAGMENTS OF THE DAMAGED IMPLANT WERE LEFT IN THE BODY. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT REPORTED. 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 20824788 ↗
• MalfunctionNov 7, 2023Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE 4.5 MM HEALIX ADVANCE TM BR ANCHOR WITH (1) 2.5 MM DYNATAPE TM IN WHITE/ BLACK AND (1) #2 DYNACORD TM IN BLUE, WITH UTILITY SHUTTLE SUTURE NO NEEDLES, BROKE MULTIPLE TIMES. 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 18084278 ↗
• MalfunctionMay 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THROUGH CLINICAL RESEARCH THAT DURING A ROTATOR CUFF REPAIR PROCEDURE OF THE LEFT SHOULDER ON (B)(6) 2022, IT WAS OBSERVED THAT THE HEALIX ADVANCE BR ANCHOR W/ DYNATAPE SUTURE TCP/PLGA ABSORBABLE ANCHOR WITH (1) 2.5MM WHITE/BLACK DY DEVICE PULLED THROUGH THE ANCHOR. 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 16979270 ↗
• MalfunctionDec 30, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE 4.5 MM HEALIX ADVANCE TM BR ANCHOR WITH (1) 2.5 MM DYNATAPE TM IN WHITE/ BLACK AND (1) #2 DYNACORD TM IN BLUE, WITH UTILITY SHUTTLE SUTURE, NO NEEDLES BROKE. 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 16080573 ↗
• MalfunctionDec 15, 2022Degraded; Migration; Degraded; Migration

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY IN-HOUSE CLINICAL RESEARCH TEAM THAT DURING A ROTATOR CUFF REPAIR/SLAP LESION REPAIR OF THE RIGHT SHOULDER ON (B)(6) 2022, IT WAS OBSERVED THAT THE 4.5 MM HEALIX ADVANCE TM BR ANCHOR WITH (1) 2.5 MM DYNATAPE TM IN WHITE/ BLACK AND (1) #2 DYNACORD TM IN BLUE, WITH UTILITY SHUTTLE SUTURE, NO NEEDLES AND THE 5.5MM HEALX ADV SP BIOCOMPOSITE ANCHOR DEVICES WERE INVOLVED IN A DEVICE MIGRATION. IT WAS FURTHER REPORTED THAT THERE WAS INADEQUATE CUTTING. 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 15990346 ↗
• MalfunctionAug 1, 2022Migration; Migration

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR WITH BICEPS TENODESIS PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE 4.5 HLX ADV BR 2.5 DYNAT WHT DEVICE PULLED OUT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15140903 ↗
• MalfunctionJun 27, 2022Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING A SHOULDER SCOPE ON (B)(6) 2022, IT WAS OBSERVED THAT WHILE USING A 4.5 MM HEALIX ADVANCE TM BR ANCHOR WITH (1) 2.5 MM DYNATAPE TM IN WHITE/ BLACK AND (1) #2 DYNACORD TM IN BLUE, WITH UTILITY SHUTTLE SUTURE NO NEEDLES DEVICE, THE ANCHOR BODY BROKE WHEN SURGEON FIRST TRIED TO ADVANCE DISTAL TIP OF ANCHOR INTO PRE PUNCHED PILOT HOLE. THEY WERE ABLE TO OPEN NEW ANCHOR AND INSERT AFTER USING TAP. SURGEON STATED HE FELT THE ANCHOR WAS FLAWED. THERE WERE NO ADVERSE PATIENT CONSEQUENCE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14834791 ↗
• InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 1 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 WHT DEVICE. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14252883 ↗
• MalfunctionFeb 25, 2022Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THROUGH A CLINICAL TRIAL THAT DURING A MEDIAL COLLATERAL LIGAMENT (MCL) REPAIR SURGERY OF THE RIGHT KNEE ON (B)(6) 2021, IT WAS OBSERVED THAT THE ANCHOR ON THE 4.5 HLX ADV BR 2.5 DYNAT WHT DEVICE BROKE WHILE BEING INSERTED INTO THE BONE. ACCORDING TO THE REPORT, 3/4 OF THE ANCHOR WAS IN BONE WITH EXCELLENT FIXATION; THEREFORE, A NEW ANCHOR WAS NOT USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13598933 ↗