HEALIX ADVANCE PEEK 3 SUTURE ANCHOR w/DYNACORD 222029Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886705029419), received between Jun 27, 2019 and Aug 27, 2024 — classified as 10 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 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 ↗
• 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-SUTURE 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 13968459 ↗
• 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-SUTURE 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 DUE TO INFECTION THAT INCLUDED IRRIGATION AND DEBRIDEMENT. ACCORDING TO THE REPORT, THE PATIENT HAD AN INFECTION, EDEMA AND PAIN POSTOPERATIVELY TO THE INITIAL PROCEDURE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 13967893 ↗
• InjuryFeb 17, 2022Adverse 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 REPORT FOR CLINICAL EVIDENCE ON SAFETY AND PERFORMANCE OF 4.5HLX ADV PK ANC-DYNA 3-SUTURE DEVICE THAT SIX MONTHS POSTOPERATIVELY TO AN INITIAL PROCEDURE OF ROTATOR CUFF REPAIR ON (B)(6) 2018, THE PATIENT HAD BICEPS TENDONITIS THAT WAS RESOLVED WITH AN INJECTION; AND THEREFORE, CANCELED THE FOLLOW-UP APPOINTMENT. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Muscle/Tendon Damage; Unspecified Tissue Injury

  MAUDE report 13549618 ↗
• InjuryJun 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER VIA PHONE THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A RIGHT ROTATOR CUFF REPAIR PROCEDURE WHERE A 5.5 HEALIX ADVANCE PEEK ANCHOR WITH DYNACORD AND A 4.5 HEALIX ADVANCE PEEK ANCHOR WITH DYNACORD WERE IMPLANTED INTO THE PATIENT'S BONE. ON (B)(6) 2019, THE PATIENT NOTICED INCREASED SWELLING AT THE SURGICAL SITE, BUT DID NOT EXPERIENCE A FEVER. ON THAT DATE, THE PATIENT HAD 5CC OF CLOUDY FLUID ASPIRATED FROM THEIR SHOULDER AND WAS DIAGNOSED WITH A P.ACNES INFECTION. ON (B)(6) 2019, A REVISION SURGERY WAS PERFORMED TO REMOVE THE TWO HEALIX ANCHORS FROM THE PATIENT'S SHOULDER. THE CUSTOMER STATED THAT ONE COMPETITOR'S IMPLANT REMAINS IN THE PATIENT'S SHOULDER. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE REPORTED THE REVISION SURGERY WAS COMPLETE BY ARTHROSCOPIC DEBIDEMENT AND REMOVAL ANCHORS. IT WAS ALSO REPORTED THAT THE PATIENT WAS PRESCRIBED IV ANTIBIOTICS FOR 4-6 WEEKS. THE ANCHORS WERE SENT TO PATHOLOGY FOR TESTING AND DISCARDED SO THEY ARE NOT AVAILABLE FOR EVALUATION. THE AFFILIATE ALSO STATED THIS WAS A P-ACNES INFECTION. 99% CHANCE THAT CAME FROM HIS SKIN, NOT THE IMPLANTS.

  Patient problems: No Code Available; Swelling; Unspecified Infection

  MAUDE report 8741342 ↗