HEALIX ADVANCE PEEK ANCHOR w/DYNACORD 222028Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886705029426), received between Nov 15, 2018 and Aug 23, 2023 — classified as 12 injuries, 2 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, 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2023Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED BY THE SALES REP IN AUSTRALIA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE STERILE FOIL PACKAGE OF 4.5MM HEALIX ADVANCE¿ PEEK ANCHOR WITH DYNACORD¿ SUTURE (BLUE AND WHITE/BLUE/GREEN) DEVICE HAD HOLE IN IT. 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 17605017 ↗
• InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4). THIS REPORT IS BEING FILED AFTER THE REVIEW OF AN INVESTIGATOR INITIATED STUDY (IIS) DPS-JMP-2020-015: RECEIPT OF ANNUAL STUDY DELIVERABLE 'MITEK DATA TEMPLATE' WHICH IS A DOWNLOAD OF DPS RELATED PRODUCTS CAPTURED WITHIN THE PRULO REGISTRY. A TOTAL OF 7 MITEK SPECIFIC PRODUCT DATA TEMPLATES WERE RECEIVED. DATA TEMPLATES CONTAIN TABS RELATING TO COMPLICATIONS/REOPERATIONS/REVISIONS HENCE BEING SUBMITTED AS A PRODUCT COMPLAINT FOR REVIEW AND CAPTURE IN THE COMPLAINT DATABASE AS RELEVANT. A PATIENT WHO WAS IMPLANTED USING THE FOLLOWING IMPLANTS: 4.5MM HEALIX ADVANCE¿ PEEK ANCHOR WITH DYNACORD¿ SUTURE (BLUE AND WHITE/BLUE/GREEN) AND 4.75MM HEALIX ADVANCE KNOTLESS PEEK ANCHOR HAD A REOPERATION PROCEDURE OF THE ROTATOR CUFF 66 DAYS AFTER INITIAL SURGERY DUE TO INFECTION THAT INCLUDED AN INFECTION WASHOUT. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 16018921 ↗
• InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 4 OF 7 FOR (B)(4). THIS REPORT IS BEING FILED AFTER THE REVIEW OF AN INVESTIGATOR INITIATED STUDY (IIS) DPS-JMP-2020-015: RECEIPT OF ANNUAL STUDY DELIVERABLE 'MITEK DATA TEMPLATE' WHICH IS A DOWNLOAD OF DPS RELATED PRODUCTS CAPTURED WITHIN THE PRULO REGISTRY. A TOTAL OF 7 MITEK SPECIFIC PRODUCT DATA TEMPLATES WERE RECEIVED. DATA TEMPLATES CONTAIN TABS RELATING TO COMPLICATIONS/REOPERATIONS/REVISIONS HENCE BEING SUBMITTED AS A PRODUCT COMPLAINT FOR REVIEW AND CAPTURE IN THE COMPLAINT DATABASE AS RELEVANT. A PATIENT WHO WAS IMPLANTED USING THE FOLLOWING IMPLANTS: 4.5MM HEALIX ADVANCE¿ PEEK ANCHOR WITH DYNACORD¿ SUTURE (BLUE AND WHITE/BLUE/GREEN) AND 5.5MM HEALIX ADVANCE KNOTLESS PEEK ANCHOR HAD A REOPERATION PROCEDURE OF THE ROTATOR CUFF 20 DAYS AFTER INITIAL SURGERY DUE TO INFECTION THAT INCLUDED AN INFECTION WASHOUT. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 16016909 ↗
• InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 1 OF 7 FOR (B)(4). THIS REPORT IS BEING FILED AFTER THE REVIEW OF AN INVESTIGATOR INITIATED STUDY (IIS) (B)(4): RECEIPT OF ANNUAL STUDY DELIVERABLE 'MITEK DATA TEMPLATE' WHICH IS A DOWNLOAD OF DPS RELATED PRODUCTS CAPTURED WITHIN THE PRULO REGISTRY. A TOTAL OF 7 MITEK SPECIFIC PRODUCT DATA TEMPLATES WERE RECEIVED. DATA TEMPLATES CONTAIN TABS RELATING TO COMPLICATIONS/REOPERATIONS/REVISIONS HENCE BEING SUBMITTED AS A PRODUCT COMPLAINT FOR REVIEW AND CAPTURE IN THE COMPLAINT DATABASE AS RELEVANT. A PATIENT WHO WAS IMPLANTED USING THE FOLLOWING IMPLANTS: 4.5MM HEALIX ADVANCE¿ PEEK ANCHOR WITH DYNACORD¿ SUTURE (BLUE AND WHITE/BLUE/GREEN), 5.5MM HEALIX ADVANCE KNOTLESS PEEK ANCHOR AND 4.75MM HEALIX ADVANCE KNOTLESS PEEK ANCHOR HAD A REVISION PROCEDURE OF THE ROTATOR CUFF DUE TO RE-TEAR WHICH INCLUDED A PLANNED TENDON TRANSFER. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16016906 ↗
• 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 STR/BL DEVICE THAT POSTOPERATIVELY TO A ROTATOR CUFF REPAIR PROCEDURE PERFORMED ON AN UNKNOWN DATE IN 2019, A PATIENT HAD A REVISION 306 DAYS AFTER THE INITIAL PROCEDURE THAT INCLUDED LYSIS OF ADHESIONS DUE TO LYSIS OF ADHESIONS FOR RIGHT SHOULDER ARTHROFIBROSIS. ACCORDING TO THE REPORT, THE PATIENT HAD JOINT STIFFNESS 48 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 13970550 ↗
• 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 STR/BL 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 13969765 ↗
• 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 STR/BL 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 13969498 ↗
• InjuryJun 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SALES REP IN AUSTRALIA THAT POST-OPERATIVELY TO A ROTATOR CUFF REPAIR PROCEDURE PERFORMED ON (B)(6) 2021, IT WAS OBSERVED THAT WHERE THEY USED A 4.5MM HEALIX ADVANCE¿ PEEK ANCHOR WITH DYNACORD¿ SUTURE DEVICE, THE PATIENT DEVELOPED C-ACNES INFECTION. THE SURGEON PERFORMED A SURGERY ON (B)(6) 2021 FOR HARDWARE REMOVAL, SUBSCAP AND ROTATOR CUFF RE-TORN, AND SHOULDER WASHED-OUT BUT ELECTED TO NOT REPAIR. THE STATUS OF THE PATIENT POST-SURGERY WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 12019162 ↗
• InjuryJun 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT POST-OPERATIVELY TO A ROTATOR CUFF REPAIR PROCEDURE PERFORMED ON (B)(6) 2021, IT WAS OBSERVED THAT WHERE THEY USED A 4.5MM HEALIX ADVANCE¿ PEEK ANCHOR WITH DYNACORD¿ SUTURE DEVICE, THE PATIENT DEVELOPED C-ACNES INFECTION. THE SURGEON PERFORMED A SURGERY ON (B)(6) 2021 FOR HARDWARE REMOVAL, SUBSCAP AND ROTATOR CUFF RE-TORN, AND SHOULDER WASHED-OUT BUT ELECTED TO NOT REPAIR. THE STATUS OF THE PATIENT POST-SURGERY WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 12019155 ↗
• InjuryJun 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT POST-OPERATIVELY TO A ROTATOR CUFF REPAIR PROCEDURE PERFORMED ON (B)(6) 2021, IT WAS OBSERVED THAT WHERE THEY USED A 4.5MM HEALIX ADVANCE" PEEK ANCHOR WITH DYNACORD" SUTURE DEVICE, THE PATIENT DEVELOPED C-ACNES INFECTION. THE SURGEON PERFORMED A SURGERY ON (B)(6) 2021 FOR HARDWARE REMOVAL, SUBSCAP AND ROTATOR CUFF RE-TORN, AND SHOULDER WASHED-OUT BUT ELECTED TO NOT REPAIR. THE STATUS OF THE PATIENT POST-SURGERY WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 12019148 ↗
• InjuryMay 14, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE SUTURE ON THE 4.5HLX ADV PK ANC-DYNA STR/BL DEVICE BROKE AND WAS LEFT IMPLANTED IN THE PATIENT. A NEW HOLE WAS MADE FOR ANOTHER LIKE DEVICE TO COMPLETE THE PROCEDURE WITH A DELAY OF FIVE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11825246 ↗
• InjuryMay 14, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE SUTURE ON THE 4.5HLX ADV PK ANC-DYNA STR/BL DEVICE BROKE AND WAS LEFT IMPLANTED IN THE PATIENT. A NEW HOLE WAS MADE FOR ANOTHER LIKE DEVICE TO COMPLETE THE PROCEDURE WITH A DELAY OF FIVE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11825231 ↗
• MalfunctionMar 17, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE DYNACORD SUTURES IN THE HA APPLICATOR GOT CAUGHT SO IT WAS HARDER TO TAKE APPLICATOR AWAY ON THE 4.5HLX ADV PK ANC-DYNA STR/BL DEVICE. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH ONLY A MINUTE DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11507465 ↗
• InjuryNov 15, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE THE SALES REP'S 4.5MM HEALIX ADVANCE PEEK ANCHOR WITH DYNACORD BROKE AFTER INSERTION. THE SALES REP STATED THE ANCHOR IS BROKEN IN THE MIDDLE OF THE ANCHOR. THE SALES REP STATED THE ISSUE MIGHT HAVE OCCURRED BECAUSE IT WAS OFF AXIS DURING INSERTION. THE SALES REP STATED THE ANCHOR WAS REMOVED BY PULLING ON THE DRIVER AND THE SUTURES TO REMOVE THE WHOLE ANCHOR WITH NO DEBRIS LEFT BEHIND. THE CASE WAS COMPLETED BY USING ANOTHER ANCHOR IN A NEW BONE HOLE WITH NO TIME DELAY. THE SALES REP STATED THERE IS NO NEED FOR SURGICAL INTERVENTION. THE ANCHOR WAS DISCARDED BY THE CUSTOMER. THERE WAS PATIENT INVOLVEMENT REPORTED. IT WAS NOT REPORTED IF THERE WAS PROLONGED HOSPITALIZATION. THE STATUS OF THE PATIENT POST-SURGERY WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 8074996 ↗