HEALIX ADVANCE BR ANCHOR w/DYNACORD 222001Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 10886705029402), received between Jan 3, 2019 and Sep 10, 2026 — classified as 5 injuries, 52 malfunctions.

The most frequently reported specific device problem is “Break” (46 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 25 most recent of 57 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Break

  It was reported that during an unspecified procedure, the HEALIX ADVANCE BR ANCHOR w/DYNACORD was broken off. All the broken parts were removed. Changed to another two HEALIX ADVANCE BR ANCHOR w/DYNACORD to continue the surgery but the same problem happened again. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information was provided.This is report 3 of 3 for (b)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50712775 ↗
• MalfunctionSep 10, 2026Break

  It was reported that during an unspecified procedure, the HEALIX ADVANCE BR ANCHOR w/DYNACORD was broken off. All the broken parts were removed. Changed to another two HEALIX ADVANCE BR ANCHOR w/DYNACORD to continue the surgery but the same problem happened again. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information was provided.This is report 2 of 3 for (b)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50712774 ↗
• MalfunctionSep 10, 2026Break

  It was reported that during an unspecified procedure, the HEALIX ADVANCE BR ANCHOR w/DYNACORD was broken off. All the broken parts were removed. Changed to another two HEALIX ADVANCE BR ANCHOR w/DYNACORD to continue the surgery but the same problem happened again. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information was provided.This is report 1 of 3 for (b)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50712769 ↗
• MalfunctionSep 4, 2026Migration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50611959 ↗
• MalfunctionAug 26, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50457852 ↗
• MalfunctionJun 16, 2026Break

  IT WAS REPORTED THAT DURING ROTATOR CUFF REPAIR SURGERY, THE HEALIX ADVANCE BR ANCHOR W/DYNACORD DEVICE ANCHOR BROKE OFF. ALL BROKEN PARTS WERE REMOVED. 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 25524075 ↗
• MalfunctionJun 8, 2026Crack

  IMPLANT WAS USED DURING SURGERY AND FRACTURING AS IT WAS IMPLANTED. USED ANOTHER DEVICE TO COMPLETE THE CASE. NO SURGICAL DELAY OR PATIENT HARM. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25427398 ↗
• MalfunctionJun 3, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE THE 4.5HLX ADV BR ANC-DYNA STR/BL DEVICE BROKE. ALL THE BROKEN PARTS WERE REMOVED. 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 25377135 ↗
• MalfunctionApr 28, 2026Break

  IT WAS REPORTED THAT DURING ARTHROSCOPY SURGERY, THE HEALIX ADVANCE BR ANCHOR W/DYNACORD ANCHOR WAS BROKEN OFF. ALL THE BROKEN PARTS WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25016540 ↗
• MalfunctionApr 27, 2026Break

  IT WAS REPORTED FROM A HEALTH AUTHORITY THAT DURING THE ROTATOR CUFF REPAIR SURGERY WITH A 4.5HLX ADV BR ANC-DYNA STR/BL DEVICE, THE ANCHOR BROKE. THEY REMOVED ALL THE BROKEN PARTS. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24996784 ↗
• MalfunctionApr 24, 2026Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE, WHILE USING THE 4.5HLX ADV BR ANC-DYNA STR/BL DEVICE, IT WAS OBSERVED THAT THE ANCHOR WAS BROKEN OFF. IT WAS REPORTED THAT THE SURGEON CHANGED TO ANOTHER 4.5HLX ADV BR ANC-DYNA STR/BL DEVICE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. IT WAS REPORTED THAT ALL BROKEN PARTS WERE REMOVED FROM THE PATIENT. IT WAS REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24988398 ↗
• MalfunctionApr 22, 2026Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE HEALIX ADVANCE BR ANCHOR DEVICE BROKE OFF. ALL BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24956271 ↗
• MalfunctionApr 20, 2026Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE 4.5HLX ADV BR ANC-DYNA STR/BL DEVICE BROKE OFF. ALL THE BROKEN PARTS WERE REMOVED. 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 24926654 ↗
• MalfunctionMar 26, 2026Break

  IT WAS REPORTED THAT DURING ROTATOR CUFF REPAIR SURGERY, THE TIP OF THE HEALIX ADVANCE BR ANCHOR W/DYNACORD ANCHOR WAS BROKEN. ALL THE BROKEN PARTS WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24696850 ↗
• MalfunctionMar 12, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE THAT THE 4.5HLX ADV BR ANC-DYNA STR/BL ANCHOR DEVICE WHEN TIGHTENED THE SUTURE, THE SUTURE BROKE OFF. 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 24583073 ↗
• MalfunctionFeb 19, 2026Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE 4.5HLX ADV BR ANC-DYNA STR/BL DEVICE BROKE OFF. ALL THE BROKEN PARTS WERE REMOVED. 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 24388496 ↗
• MalfunctionFeb 17, 2026Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE 4.5HLX ADV BR ANC-DYNA STR/BL DEVICE BROKE OFF. ALL THE BROKEN PARTS WERE REMOVED. A REPLACEMENT DEVICE WAS USED TO CONTINUE THE SURGERY, BUT THE SAME ISSUE OCCURRED AGAIN. 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 24369917 ↗
• MalfunctionFeb 17, 2026Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE 4.5HLX ADV BR ANC-DYNA STR/BL DEVICE BROKE OFF. ALL THE BROKEN PARTS WERE REMOVED. A REPLACEMENT DEVICE WAS USED TO CONTINUE THE SURGERY, BUT THE SAME ISSUE OCCURRED AGAIN. 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 24369916 ↗
• MalfunctionJan 28, 2026Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE 4.5HLX ADV BR ANC-DYNA STR/BL ANCHOR DEVICE WAS BROKEN OFF. IT WAS REPORTED THAT ALL THE BROKEN PARTS WERE REMOVED. IT WAS REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24198374 ↗
• MalfunctionDec 31, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 4.5HLX ADV BR ANC-DYNA STR/BL DEVICE ANCHOR BROKE OFF. THE TIP OF THE ANCHOR WAS BROKEN OFF. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23936833 ↗
• InjuryOct 23, 2025Migration; Migration

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE FOR RIGHT SHOULDER CUFF INJURY, IT WAS OBSERVED THAT WHILE USING THE 4.5HLX ADV BR ANC-DYNA STR/BL DEVICE, TWO ANCHORS WERE PLACED AT THE GREATER TUBEROSITY OF THE HUMERUS TO FIX THE TORN SUPRASPINATUS, AND THE OPERATION WAS COMPLETED SUCCESSFULLY. IT WAS REPORTED THAT POST SURGERY, THREE DAYS LATER, AN MRI OF THE RIGHT SHOULDER REVEALED ANCHOR LOOSENING AND A FAILURE OF IMPLANT FIXATION WAS CONSIDERED. ACCORDING TO THE REPORTER, THE NEXT DAY, A "RIGHT ROTATOR CUFF REPAIR" WAS PERFORMED UNDER GENERAL ANESTHESIA AND DURING THE OPERATION ONE ANCHOR WAS LOOSENED AND DETACHED, WHICH WAS REMOVED, AND THEN ONE ANCHOR WAS RE-PLACED IN THE FOOTPRINT AREA OF GREATER TUBEROSITY OF HUMERUS TO FIX THE SUPERIOR MUSCLE ON THE STOP POINT OF GREATER TUBEROSITY. IT WAS REPORTED THAT THE OPERATION WENT SMOOTHLY, AND THE RIGHT UPPER LIMB CERVICO-WRIST BAND WAS IMMOBILIZED AFTER THE OPERATION. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23368991 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE 4.5HLX ADV BR ANC-DYNA STR/BL DEVICE BROKE OFF. ALL THE BROKEN PARTS WERE REMOVED. 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 23301994 ↗
• MalfunctionSep 11, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, THE 4.5HLX ADV BR ANC-DYNA STR/BL ANCHOR DEVICE WAS BROKEN OFF. IT WAS REPORTED THAT ALL THE BROKEN PARTS WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23027666 ↗
• MalfunctionAug 26, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 4.5HLX ADV BR ANC-DYNA STR/BL ANCHOR DEVICE WAS BROKEN OFF. IT WAS REPORTED THAT ALL BROKEN PARTS WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22895893 ↗
• MalfunctionAug 22, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE; IT WAS DISCOVERED THAT THE ANCHOR ON THE 4.5HLX ADV BR ANC-DYNA STR/BL DEVICE BROKE OFF. ALL THE BROKEN PARTS WERE REMOVED. 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 22872895 ↗