HEALIX ADVANCE 222581Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10886705030309), received between May 14, 2019 and Jun 1, 2026 — classified as 5 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Break” (21 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2026Crack

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THE 4.75 HEALIX ADVANCE KNTLS BR ANCHOR DEVICE CRACKED WHEN LOADING SUTURE. 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 25350606 ↗
• MalfunctionJun 10, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, AFTER TWO SUTURES WERE PASSED THOUGH THE 4.75 HEALIX ADVANCE KNTLSS BR ANCHOR DEVICE, IT WAS OBSERVED THE ANCHOR DEVICE BROKE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22179452 ↗
• MalfunctionMar 31, 2025Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN OPEN TRICEPS REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE ANCHORS OF TWO 4.75 HEALIX ADVANCE KNTLS BR DEVICES HAD BROKEN OFF. THE REPORTER STATED THAT WHILE THE ANCHORS WERE BEING INSERTED INTO THE BONE, THE TOP PORTION OF EACH ANCHOR CIRCUMFERENTIALLY BROKE OFF, BUT THE BOTTOM TWO-THIRDS REMAINED IN THE PATIENT AND HELD SECURELY. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT THE SURGERY WAS COMPLETED AS INTENDED. 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 21730300 ↗
• MalfunctionMar 31, 2025Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN OPEN TRICEPS REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE ANCHORS OF TWO 4.75 HEALIX ADVANCE KNTLS BR DEVICES HAD BROKEN OFF. THE REPORTER STATED THAT WHILE THE ANCHORS WERE BEING INSERTED INTO THE BONE, THE TOP PORTION OF EACH ANCHOR CIRCUMFERENTIALLY BROKE OFF, BUT THE BOTTOM TWO-THIRDS REMAINED IN THE PATIENT AND HELD SECURELY. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT THE SURGERY WAS COMPLETED AS INTENDED. 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 21730298 ↗
• InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 3 OF 3 FOR (B)(4). IT WAS REPORTED THROUGH A POST MARKET STUDY THAT A PATIENT HAD UNDERGONE A ROTATOR CUFF REPAIR PROCEDURE WITH BICEPS TENODESIS AND SUPRA + SUBSCAPULARIS REPAIR ON (B)(6) 2024, USING TWO 4.75 HEALIX ADVANCE KNTLS BR DEVICES AND ONE SUPER QA+ O/C DS CP-2 DEVICE. ACCORDING TO THE REPORT, A POST OPERATIVE FALL OCCURRED RESULTING IN ANATOMIC NECK FRACTURE OF THE PROXIMAL HUMERUS AND A RETEAR OF THE ROTATOR CUFF. IT WAS REPORTED THAT THIS HAD ULTIMATELY APPEARED TO HAVE HEALED BUT A REVERSE SHOULDER ARTHROPLASTY PROCEDURE WAS NEEDED AND PERFORMED ON (B)(6) 2024. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20440609 ↗
• InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED THROUGH A POST MARKET STUDY THAT A PATIENT HAD UNDERGONE A ROTATOR CUFF REPAIR PROCEDURE WITH BICEPS TENODESIS AND SUPRA + SUBSCAPULARIS REPAIR ON (B)(6) 2024, USING TWO 4.75 HEALIX ADVANCE KNTLS BR DEVICES AND ONE SUPER QA+ O/C DS CP-2 DEVICE. ACCORDING TO THE REPORT, A POST OPERATIVE FALL OCCURRED RESULTING IN ANATOMIC NECK FRACTURE OF THE PROXIMAL HUMERUS AND A RETEAR OF THE ROTATOR CUFF. IT WAS REPORTED THAT THIS HAD ULTIMATELY APPEARED TO HAVE HEALED BUT A REVERSE SHOULDER ARTHROPLASTY PROCEDURE WAS NEEDED AND PERFORMED ON (B)(6) 2024. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20440574 ↗
• MalfunctionFeb 28, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE PERFORMED ON (B)(6) 2024 IT WAS OBSERVED THAT THE TIP OF THE 4.75 HEALIX ADVANCE KNTLS BR ANCHOR DEVICE BROKE WHEN LOADING SUTURES THROUGH THE EYELET (2 DYNACORD THROUGH EACH EYELET). ANOTHER ANCHOR WAS OPENED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THERE WAS A CASE DELAY OF LESS THAN 5 MINUTES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18797444 ↗
• InjuryNov 16, 2023Adverse 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 THAT DURING A ROTATOR CUFF REPAIR PROCEDURE OF THE RIGHT SHOULDER ON (B)(6) 2022 DUE TO A RECURRENT ROTATOR CUFF TEAR WITH SEVERE BICIPITAL TENOSYNOVITIS, A 4.75 HEALIX ADVANCE KNTLS BR DEVICE AND A 4.5HLX ADV BR ANC-DYNA 3-SUT DEVICE WERE USED. ACCORDING TO THE REPORT, A SHOULDER ARTHROSCOPY WITH REVISION ROTATOR CUFF REPAIR WAS PERFORMED ON (B)(6) 2023 WITH A DOUBLE ROW APPROACH WITH MULTIPLE LOCK SUTURES. IT WAS FURTHER REPORTED THAT THE REVISION PROCEDURE INCLUDED AN ARTHROSCOPIC LIMITED DEBRIDEMENT INCLUDING REMOVAL OF RETAINED AND PREVIOUS SUTURE MATERIAL. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Inflammation; Unspecified Tissue Injury

  MAUDE report 18155369 ↗
• InjuryOct 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A RIGHT ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, THE 4.75 HEALIX ADVANCE KNTLS BR DEVICE, 5.5 HEALIX ADVANCE KNTLS BR, 4.5HLX ADV BR ANC-DYNA 3-SUT DEVICES WERE BEING USED WHEN THE PATIENT EXPERIENCED RE-TEARS OR NEW TEARS POST OPERATIVELY. IT WAS REPORTED THAT THIS RESULTED IN THE PATIENT REQUIRING A RE-OPERATION/REVISION PROCEDURE. IT WAS RECOMMENDED A RIGHT SHOULDER TISSUE AND CULTURE ACQUISITION, REVERSE TOTAL SHOULDER ARTHROPLASTY AND POSSIBLE BICEPS TENODESIS BE PERFORMED. IT WAS REPORTED THAT THIS EVENT OCCURRED AS A PART OF A CLINICAL TRIAL. IT WAS REPORTED THAT THE SEVERITY WAS SEVERE. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17930073 ↗
• InjuryJun 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THROUGH CLINICAL RESEARCH THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, A 4.75 HEALIX ADVANCE KNOTLESS BR DEVICE WAS USED. ACCORDING TO THE REPORT, THE PATIENT FELL ON (B)(6) 2023 AND INJURED THE LEFT SHOULDER SEVERELY THAT REQUIRED A REVISION PROCEDURE. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17228017 ↗
• MalfunctionJun 23, 2023Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT TWO (2) 4.75 HEALIX ADVANCE KNOTLESSS BR DEVICES WERE TRIED TO DEPLOYED BUT THE NOSE BROKE OFF. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. 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 17193346 ↗
• MalfunctionJun 23, 2023Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE ON (B)(6)2023, IT WAS OBSERVED THAT TWO (2) 4.75 HEALIX ADVANCE KNOTLESSS BR DEVICES WERE TRIED TO DEPLOYED BUT THE NOSE BROKE OFF. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. 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 17193345 ↗
• MalfunctionFeb 24, 2022Crack; Crack

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE ANCHOR ON THE 4.75 HEALIX ADVANCE KNTLS BR DEVICE WAS SHREDDING AS IT WAS BEING INSERTED. THE SURGEON WAS CONCERNED THE MATERIAL WAS NOT AS ROBUST AS NORMAL. THE ANCHOR WAS IMPLANTED WITHOUT MAJOR ISSUES BESIDES ITS THREAD MATERIAL SEEMINGLY SHREDDING OFF. 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 13591683 ↗
• MalfunctionNov 16, 2021Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING A SHOULDER ARTHROSCOPY ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE NOSE OF THE 4.75 HEALIX ADVANCE KNTLS BR ANCHOR DEVICE CRACKED AND BROKE OFF WHEN PULLING ON THE RED TAB TO SHUTTLE THE SUTURE. ACCORDING TO THE REPORT, 6 TAILS OF # 2 DYNACORD WERE TRYING TO LOAD INTO THE DEVICE WHEN THE EVENT OCCURRED. 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 12822088 ↗
• MalfunctionNov 16, 2021Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING A SHOULDER ARTHROSCOPY ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE NOSE OF THE 4.75 HEALIX ADVANCE KNTLS BR ANCHOR DEVICE CRACKED AND BROKE OFF WHEN PULLING ON THE RED TAB TO SHUTTLE THE SUTURE. ACCORDING TO THE REPORT, 6 TAILS OF #2 DYNACORD WERE TRYING TO LOAD INTO THE DEVICE WHEN THE EVENT OCCURRED. 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 12822085 ↗
• MalfunctionOct 12, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ARTHROSCOPIC SHOULDER STABILIZATION PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE 4.75 HEALIX ADVANCE KNTLS BR BROKE WHILE SUTURING. 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 12614411 ↗
• MalfunctionApr 28, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT A 4.75 HEALIX ADVANCE KNOTLESSS BR ANCHOR DEVICE BROKE WHILE TRYING TO LOCK THE DYNACORD SUTURE. 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 11739787 ↗
• MalfunctionApr 28, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT A 4.9MM HEALX ADV SP BIOCOMPOSITE ANCHOR DEVICE BROKE WHILE TRYING TO LOCK THE DYNACORD SUTURE. 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 11739780 ↗
• MalfunctionApr 5, 2021Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING A SUBSCAPULARIS REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE ANCHOR DEVICE BROKE. THERE WERE NO FRAGMENTS WERE GENERATED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11614819 ↗
• MalfunctionApr 5, 2021Break; Break

  IT WAS REPORTED BY SALES REP VIA PHONE THAT DURING A SUBSCAPULARIS REPAIR TWO 4.75 HEALIX ADVANCE KNOTLESS BR BROKE. NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED. NO FRAGMENTS WERE GENERATED. PROCEDURE WAS COMPLETED WITH SAME PRODUCT REPLACEMENTS. DEVICES WERE DISCARDED BY STAFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11614818 ↗
• MalfunctionApr 1, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE ANCHOR DEVICE BROKE UPON INSERTION. THE TIP OF THE ANCHOR DEVICE WAS REMOVED FROM THE BONE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY NOR ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11604125 ↗
• MalfunctionMar 25, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR ON (B)(6) 2021, IT WAS OBSERVED THAT THE ANCHOR DEVICE 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 11569901 ↗
• MalfunctionDec 29, 2020Break; Break

  IT WAS REPORTED VIA COMPLAINT SUBMISSION TOOL THAT DURING A ROTATOR CUFF REPAIR THE DOCTOR TRIES TO PULL THROUGH 4 SUTURES (2 IN PROXIMAL KITE, 2 IN DISTAL) A PIECE OF THE NOSE OF THE 4.75 HEALIX ADVANCE KNOTLESS BR BROKE OFF. THEY OPENED A NEW ANCHOR TO COMPLETE PROCEDURE WITH NO SURGICAL DELAY OR PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11088174 ↗
• MalfunctionOct 23, 2020Break; Break

  THIS IS REPORT 4 OF 4 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING AN ACHILLES TENDON REPAIR PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE SUTURES OF TWO 4.9MM HEALLIX ADV SP BIOCOMPOSITE ANCHOR AND TWO 4.75 HEALIX ADVANCE KNOTLESS BR BROKE DUE TO THE TECHNIQUE OF THE SURGEON. THERE WAS A TEN MINUTE DELAY IN THE PROCEDURE TO REMOVE ALL THE DEVICES AND START OVER. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Not Applicable

  MAUDE report 10726328 ↗
• MalfunctionOct 23, 2020Break; Break

  THIS IS REPORT 2 OF 4 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING AN ACHILLES TENDON REPAIR PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE SUTURES OF TWO 4.9MM HEALLIX ADV SP BIOCOMPOSITE ANCHOR AND TWO 4.75 HEALIX ADVANCE KNOTLESS BR BROKE DUE TO THE TECHNIQUE OF THE SURGEON. THERE WAS A TEN MINUTE DELAY IN THE PROCEDURE TO REMOVE ALL THE DEVICES AND START OVER. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Not Applicable

  MAUDE report 10726324 ↗