HEALIX ADVANCE PEEK 3 SUTURE ANCHOR w/DYNACORDRecalls & reported problems across all models

We found 2 models of HEALIX ADVANCE PEEK 3 SUTURE ANCHOR w/DYNACORD by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Jun 27, 2019 and Sep 10, 2025 — classified as 12 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported HEALIX ADVANCE PEEK 3 SUTURE ANCHOR w/DYNACORD problems

HEALIX ADVANCE PEEK 3 SUTURE ANCHOR w/DYNACORD models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• HEALIX ADVANCE PEEK 3 SUTURE ANCHOR w/DYNACORD 222029

  Fastener, fixation, nondegradable, soft tissue
  12 reports
• HEALIX ADVANCE PEEK 3 SUTURE ANCHOR w/DYNACORD 222033

  Fastener, fixation, nondegradable, soft tissue
  8 reports

Recent HEALIX ADVANCE PEEK 3 SUTURE ANCHOR w/DYNACORD adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2025Migration; Migration

  IT WAS REPORTED THAT AT THE BEGINNING OF AN UNSPECIFIED SURGICAL PROCEDURE, THE SUTURES ARE PLACED IN THE BICEPS WHICH ARE FIXED TO THE HUMERUS BY MEANS OF A KNOTLESS 4.75 HEALIX ADVANCE KNTLS PEEK ANCHOR DEVICE WHICH BEGINS WITH ITS RESPECTIVE PURPLE INITIATOR. THE DEVICE BEGINS TO LOWER THE ANCHOR DEVICE BUT THERE IS A LOT OF TENSION OF THE TISSUE AND OPENS THE TIP OF THE ANCHOR PREVENTING IT TO HOLD INSIDE THE BONE. THE ANCHOR DEVICE WAS EXPELLED FROM THE BONE MAKING IT NECESSARY TO PASS A SECOND KNOTLESS SUTURE. A SELF-DRILLING 4.9 HEALIX ADV SP PEEK CE DEVICE IS PASSED, WHICH REMAINED PROPERLY IN THE BONE. THE PROCEDURE CONTINUED WITH A SUTURE OF THE ROTATOR CUFF, WITH A 5.5HLX ADV PK ANC-DYNA 3-SUT DEVICE. THE ANCHOR WAS SCREWED INTO THE BONE, AND THE SUTURES WERE STARTED IN THE CUFF. IT WAS OBSERVED THAT THE ANCHOR WAS EXPELLED FROM THE BONE AND REMAINED ON THE OUTSIDE. THE DOCTOR REQUESTED A SECOND ANCHOR OF THE SAME SIZE, WHICH WAS PLACED IN A DIFFERENT POSITION IN THE BONE, AND FUNCTIONED PROPERLY. AT THE END OF THE PROCEDURE, THE SUTURES WERE CUT AND IT WAS OBSERVED THAT THE PREVIOUSLY INSERTED KNOTLESS SP ANCHOR, HAD ALSO BEEN EXPELLED FROM THE BONE. IT WAS NOT REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23020108 ↗
• MalfunctionAug 6, 2025Break; Break

  THIS IS REPORT 1 OF 2 FOR PC-(B)(4). IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE SUTURE ON THE 5.5HLX ADV PK ANC-DYNA 3-SUT DEVICE BROKE, AND WHILE INSERTING THE 5.5 HEALIX ADVANCE KNTLS PEEK DEVICE, THE TIP EITHER BROKE OFF OR BECAME BENT. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS SPARE DEVICES WERE AVAILABLE TO COMPLETE THE SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22727671 ↗
• MalfunctionApr 1, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE TIP OF THE 5.5HLX ADV PK ANC-DYNA 3-SUT DEVICE BROKE OFF. ACCORDING TO THE REPORTER, THE DOCTOR USED A SMALLER PUNCH TO INSERT THE ANCHOR INTO THE HARD CORTICAL BONE. DUE TO THE NATURE OF THE BONE, THEY HAD TO POSITION IT AT A SPECIFIC ANGLE, REFERRED TO AS A DEAD MAN'S ANGLE. HOWEVER, WHEN ATTEMPTING TO INSERT THE TIP OF THE 5.5HLX ADV PK ANC-DYNA 3-SUT DEVICE, THE TIP BROKE OFF. TO ADDRESS THIS ISSUE, THE DOCTOR SUCCESSFULLY REMOVED THE ANCHOR ALONG WITH THE REMAINING PORTION THAT WAS STILL IN PLACE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS USED 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 21741258 ↗
• MalfunctionAug 27, 2024Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE 4.5MM HEALIX ADVANCE PEEK ANCHOR WITH DYNACORD SUTURE DEVICE BROKE IMMEDIATELY, EVEN THOUGH IT WAS INSERTED CORRECTLY. 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. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20075745 ↗
• MalfunctionDec 13, 2023Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON AN UNKNOWN DATE THE4.5HLX ADV PK ANC DEVICE WAS UNSTERILE WHEN TAKING IT OUT OF THE WHITE BOX. THE SEAL WAS NOT ALL THE WAY CLOSED. ANOTHER ANCHOR WAS USED. NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18320980 ↗
• MalfunctionMay 4, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN GERMANY THAT DURING A SHOULDER SCOPE PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE 5.5MM HEALIX ADVANCE¿ PEEK ANCHOR WITH DYNACORD¿ SUTURE (BLUE, WHITE/BLUE/GREEN, WHITE/BLACK) DEVICE WAS DELIVERED "UNSTERILE" IN A CARDBOARD BOX; AND THEREFORE, COULD NOT BE USED. ACCORDING TO THE REPORT, THE CARDBOARD PACKAGING WAS INTACT, BUT THE ALUMINUM FOILS/STERILE FOILS AROUND THE DEVICE WERE OPEN AND NO LONGER STERILELY SEALED. 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 16872389 ↗
• MalfunctionApr 11, 2023Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED BY THE AFFILIATE IN GERMANY THAT PREOPERATIVELY TO AN SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE 5.5MM HEALIX ADVANCE¿ PEEK ANCHOR WITH DYNACORD¿ SUTURE (BLUE, WHITE/BLUE/GREEN, WHITE/BLACK) WAS DELIVERED ¿NON-STERILE¿ IN A CARDBOARD BOX. ACCORDING TO THE REPORT, THE CARDBOARD OUTER PACKAGING WAS INTACT, BUT THE ALUMINUM FOIL AROUND THE HEALIX ANCHOR WAS OPEN OR NO LONGER STERILE SEALED. 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 16716853 ↗
• InjuryMar 8, 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 RESEARCH THAT ON 7/14/2022, A PATIENT UNDERWENT A ROTATOR CUFF REPAIR PROCEDURE USING A 4.5MM HEALIX ADVANCE¿ PEEK ANCHOR WITH DYNACORD¿ SUTURE (BLUE, WHITE/BLUE/GREEN, WHITE/BLACK) DEVICE. ACCORDING TO THE REPORT, POSTOPERATIVELY ON (B)(6) 2022, THE PATIENT HAD A REVISION/REOPERATION DUE TO RE-TEARS/NEW TEARS. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16502786 ↗
• MalfunctionDec 27, 2022Crack; Crack

  IT WAS REPORTED BY THE SALES REP IN HONG KONG THAT DURING AN ARTHROSCOPIC PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE TIP ON THE 5.5MM HEALIX ADVANCE¿ PEEK ANCHOR WITH DYNACORD¿ SUTURE (BLUE, WHITE/BLUE/GREEN, WHITE/BLACK) DEVICE CRACKED WHEN LOADING SUTURE. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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 16052115 ↗
• 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 4.5HLX ADV PK ANC-DYNA 3-SUT DEVICE THAT POSTOPERATIVELY TO A ROTATOR CUFF REPAIR PROCEDURE PERFORMED ON AN UNKNOWN DATE IN 2019, A PATIENT HAD A REVISION 539 DAYS AFTER THE INITIAL PROCEDURE THAT INCLUDED SUPERIOR CAPSULAR RECONSTRUCTION OF THE SUPRASPINATUS CAPSULE WITH TENSOR FASCIA LATA AUTOGRAFT DUE TO SUPRASPINATUS TEAR. ACCORDING TO THE REPORT, THE PATIENT HAD LOOSENING OF THE GRAFT 279 DAYS AFTER THE INITIAL PROCEDURE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13970813 ↗
• 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 5.5HLX ADV PK ANC-DYNA 3-SUT DEVICE THAT POSTOPERATIVELY TO A ROTATOR CUFF REPAIR PROCEDURE PERFORMED ON AN UNKNOWN DATE IN 2019, A PATIENT HAD A REVISION 539 DAYS AFTER THE INITIAL PROCEDURE THAT INCLUDED SUPERIOR CAPSULAR RECONSTRUCTION OF THE SUPRASPINATUS CAPSULE WITH TENSOR FASCIA LATA AUTOGRAFT DUE TO SUPRASPINATUS TEAR. ACCORDING TO THE REPORT, THE PATIENT HAD LOOSENING OF THE GRAFT 279 DAYS AFTER THE INITIAL PROCEDURE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13970713 ↗
• 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 4.5HLX ADV PK ANC-DYNA 3-SUT DEVICE THAT POSTOPERATIVELY TO A ROTATOR CUFF REPAIR PROCEDURE PERFORMED ON AN UNKNOWN DATE IN 2019, A PATIENT HAD A REOPERATION 129 DAYS AFTER THE INITIAL PROCEDURE THAT INCLUDED IRRIGATION, DEBRIDEMENT, AND OPEN SYNOVECTOMY DUE TO POSTOPERATIVE INFECTION IN THE LEFT SHOULDER. ACCORDING TO THE REPORT, THE PATIENT HAD THE INFECTION AND PAIN 122 DAYS AFTER THE INITIAL PROCEDURE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 13970033 ↗
• 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 4.5HLX ADV PK ANC-DYNA 3-SUT DEVICE THAT POSTOPERATIVELY TO A ROTATOR CUFF REPAIR PROCEDURE PERFORMED ON AN UNKNOWN DATE IN 2019, A PATIENT HAD A REOPERATION 147 DAYS AFTER THE INITIAL PROCEDURE THAT INCLUDED A LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY DUE TO FULL-THICKNESS RE-TEAR OF THE SUPRASPINATUS AND THEN NEAR FULL-THICKNESS INCOMPLETE TEAR OF THE INFRASPINATUS. ACCORDING TO THE REPORT, THE PATIENT HAD TENDON RE-TEAR 84 DAYS AFTER THE INITIAL PROCEDURE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13969847 ↗
• 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 4.5HLX ADV PK ANC-DYNA 3-SUT DEVICE THAT POSTOPERATIVELY TO A ROTATOR CUFF REPAIR PROCEDURE PERFORMED ON AN UNKNOWN DATE IN 2019, A PATIENT HAD A REOPERATION 77 DAYS AFTER THE INITIAL PROCEDURE DUE TO STIFFNESS THAT INCLUDED CAPSULAR RELEASE MANIPULATION UNDER ANESTHESIA. ACCORDING TO THE REPORT, THE PATIENT HAD JOINT STIFFNESS 40 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 13969499 ↗
• 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 4.5HLX ADV PK ANC-DYNA 3-SUT DEVICE THAT POSTOPERATIVELY TO A ROTATOR CUFF REPAIR PROCEDURE PERFORMED ON AN UNKNOWN DATE IN 2019, A PATIENT HAD A REOPERATION 77 DAYS AFTER THE INITIAL PROCEDURE DUE TO STIFFNESS THAT INCLUDED CAPSULAR RELEASE MANIPULATION UNDER ANESTHESIA. ACCORDING TO THE REPORT, THE PATIENT HAD JOINT STIFFNESS 40 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 13969428 ↗

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