HEALIX ADVANCE ORTHOCORD 222297Recalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 10886705021338), received between Apr 3, 2018 and Sep 23, 2026 — classified as 9 injuries, 68 malfunctions.

The most frequently reported specific device problem is “Break” (51 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 77 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Break

  This is report 2 of 3 of (b)(4).It was reported that during a Rotator Cuff Repair surgery, the HEALIX ADVANCE ORTHOCORD device anchor broke off. All broken parts were removed. Changed to another two to continue the surgery, the same problem happened again. Another device was used to complete the procedure. 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 50873778 ↗
• MalfunctionSep 22, 2026Break

  This is report 3 of 3 of (b)(4). It was reported that during a Rotator Cuff Repair surgery, the HEALIX ADVANCE ORTHOCORD device anchor broke off. All broken parts were removed. Changed another two to continue the surgery, the same problem happened again. Another device was used to complete the procedure. 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 50855019 ↗
• MalfunctionSep 22, 2026Break

  This is report 1 of 3 of (b)(4).It was reported that during a Rotator Cuff Repair surgery, the HEALIX ADVANCE ORTHOCORD device anchor broke off. All broken parts were removed. Changed another two to continue the surgery, the same problem happened again. Another device was used to complete the procedure. 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 50855010 ↗
• MalfunctionSep 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829400 ↗
• MalfunctionSep 16, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50788478 ↗
• MalfunctionJul 31, 2026Break

  Patient problems: Insufficient Information

  MAUDE report 50100116 ↗
• MalfunctionJun 15, 2026Break

  THIS IS REPORT 1 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY, THE HEALIX ADVANCE ORTHOCORD DEVICE ANCHOR BROKE OFF. ALL BROKEN PARTS WERE REMOVED. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. 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 25503539 ↗
• MalfunctionFeb 10, 2026Break

  IT WAS REPORTED THAT DURING A SHOULDER REPAIR SURGERY, THE 5.5 HEALIX ADVANCE BR W/OCORD ANCHOR DEVICE BROKE WHEN SCREWING INSIDE THE BONE. TO RESOLVE THE ISSUE, ANOTHER LIKE DEVICE WAS USED. IT WAS REPORTED THAT THE SURGERY WAS PROLONGED FOR 30 MINUTES DUE TO THE EVENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24308900 ↗
• MalfunctionJan 14, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, WHILE USING A 5.5 HEALIX ADVANCE BR W/OCORD ANCHOR DEVICE, IT WAS OBSERVED THAT THE ANCHOR SCREW BROKE AT ITS CENTRAL PART WHILE BEING SCREWED IN. IT WAS REPORTED THAT ANOTHER 5.5 HEALIX ADVANCE BR W/OCORD ANCHOR DEVICE FROM THE SAME BATCH WAS THEN USED, BUT THIS DEVICE ALSO BROKE AT ITS CENTRAL LOCATION WHILE BEING SCREWED IN. 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 24068191 ↗
• MalfunctionDec 24, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE 5.5 HEALIX ADVANCE BR W/OCORD DEVICE, THE OMNISPAN MENISCAL REPAIR 27DEG DEVICE AND THE MENISCAL DEPLOYMENT GUN DEVICE WAS BEING USED WHEN THE ANCHOR WAS BROKEN OFF, REMOVED ALL THE BROKEN PARTS. AND THE 2ND PLATE DETACHED BEFORE DEPLOYMENT. 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 THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888749 ↗
• MalfunctionDec 15, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, THE 5.5 HEALIX ADVANCE BR W/OCORD ANCHOR DEVICE WAS BROKEN OFF. IT WAS REPORTED THAT ALL BROKEN PARTS WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. ADDITIONALLY, IT WAS REPORTED THAT THERE WAS FOREIGN MATTER OBSERVED ON THE VAPR PREMIERE 90 ELECTRODE DEVICE. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23806067 ↗
• MalfunctionDec 2, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, THE 5.5 HEALIX ADVANCE BR W/OCORD DEVICE BROKE DURING SHOULDER SCOPE / ROTATOR CUFF AND DOCTOR TAPPED AND OPENED A NEW ANCHOR TO COMPLETE THE CASE WITHOUT PATIENT CONSEQUENCE OR TIME DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693784 ↗
• MalfunctionJun 20, 2025Detachment of Device or Device Component; Mechanical Jam; Detachment of Device or Device Component; Mechanical Jam

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGICAL PROCEDURE WHILE USING THE 5.5 HEALIX ADVANCE BR W/OCORD DEVICE, WHEN INSTALLING THE ANCHOR, THE HANDLE BECAME DISCONNECTED FROM THE ANCHOR HOLDER TIP, AND THEN THE HOLDER TIP GOT STUCK IN THE ANCHOR. THE SURGEON REMOVED THE REMAINS OF THE ANCHOR HOLDER USING INSTRUMENTS AVAILABLE IN THE OPERATING ROOM. THERE WAS NO REPORTS OF A DELAY TO 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 22301610 ↗
• MalfunctionMay 6, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE THE 5.5 HEALIX ADVANCE BR W/OCORD DEVICE ANCHOR WAS BROKEN OFF. ALL BROKEN PARTS WERE REMOVED. 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 21972138 ↗
• MalfunctionMar 21, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE 5.5 HEALIX ADVANCE BR W/OCORD DEVICE ANCHOR WAS BROKEN OFF, REMOVED ALL THE BROKEN PARTS. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21665763 ↗
• MalfunctionFeb 26, 2025Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT PROCEDURE, UPON OPENING THE PACKAGING OF THE 5.5 HEALIX ADVANCE BR W/OCORD DEVICE, IT WAS DISCOVERED THAT THE ANCHOR'S THREADS WERE UNEVEN, PREVENTING SUCCESSFUL IMPLANTATION INTO THE PATIENT. DURING THE IN-HOUSE ENGINEERING REVIEW OF THE RETURNED PHOTOS, IT WAS FOUND THAT THE DEVICE WAS STRIPPED, WORN, TWISTED, AND CROSS-THREADED. 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 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 21469478 ↗
• MalfunctionJan 15, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ROTATOR CUFF REPAIR PROCEDURE, IT WAS OBSERVED THAT THE ANCHOR ON THE DEVICE BROKE OFF, THEN ALL THE BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21158597 ↗
• InjuryNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING POST-SURGERY FOR AN UNSPECIFIED SURGERY USING THE 5.5 HEALIX ADVANCE BR W/OCORD DEVICE AND 5.5 HEALIX ADVANCE KNTLSS BR DEVICE A CONTROL MRI WAS PERFORMED SIX MONTHS LATER AND THERE WERE NO SIGNS OF INFECTION OR INFLAMMATION. IT WAS REPORTED THAT THE PATIENT'S PAIN INCREASED, AND AN MRI OF THE HUMERAL HEAD IN THE AREA WHERE THE FIXATOR WAS INSTALLED VISUALIZED A CYST. ACCORDING TO THE REPORTER THERE WERE NO SIGNS OF RESORPTION OR REPLACEMENT OF THE FIXATOR WITH BONE TISSUE. THERE ARE NO PLANS TO REMOVE THE RETAINERS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cyst(s); Pain

  MAUDE report 20704998 ↗
• MalfunctionNov 5, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE THE 5.5 HEALIX ADVANCE BR W/OCORD DEVICE ANCHOR WAS BROKEN OFF. ALL BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20610360 ↗
• MalfunctionJun 24, 2024Break; Break

  REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE HEALTHARE PROFESSIONAL IN CHINA THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE ON (B)(6) 2024 THE 5.5 HEALIX ADVANCE BR3SUT W/OC DEVICE AND 5.5 HEALIX ADVANCE BR W/OCORD DEVICE ANCHORS WERE BROKEN OFF, REMOVED ALL BROKEN PARTS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19594613 ↗
• MalfunctionMay 20, 2024Break; Break

  REPORT 2 OF 3 FOR (B)(4). IT WAS REPORTED FROM THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 5.5 HEALIX ADVANCE BR W/OCORD ANCHOR DEVICE WAS BRITTLE THROUGHOUT THE SURGERY. ACCORDING TO THE REPORTER THE SURGEON WAS TYING KNOTS AND USING THE KNOT PUSHER, WHEN THE ORTHOCORD RIPPED INSIDE THE PATIENT'S BODY. IT WAS REPORTED THAT THE OTHOCORD WAS GRABBED BECAUSE THEY WANTED TO DO SOME FREEHAND PASSES IN ABSENCE OF THE SUTURE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A TWO TO THREE MINUTE DELAY IN THE PROCEDURE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19349732 ↗
• MalfunctionMay 20, 2024Break; Break

  REPORT 3 OF 3 FOR (B)(4). IT WAS REPORTED FROM THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 5.5 HEALIX ADVANCE BR W/OCORD ANCHOR DEVICE WAS BRITTLE THROUGHOUT THE SURGERY. ACCORDING TO THE REPORTER THE SURGEON WAS TYING KNOTS AND USING THE KNOT PUSHER, WHEN THE ORTHOCORD RIPPED INSIDE THE PATIENT'S BODY. IT WAS REPORTED THAT THE OTHOCORD WAS GRABBED BECAUSE THEY WANTED TO DO SOME FREEHAND PASSES IN ABSENCE OF THE SUTURE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A TWO TO THREE MINUTE DELAY IN THE PROCEDURE REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19349729 ↗
• MalfunctionOct 11, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2023 THE 5.5 HEALIX ADVANCE BR W/OCORD DEVICE SUTURE BROKE WHEN THE SUTURE WAS TIGHTENED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN OFF. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE AND NO DELAYS WERE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17913224 ↗
• InjuryAug 2, 2023Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN COLOMBIA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE SUTURE ON THE 5.5 HEALIX ADVANCE BR ANCHOR WITH ORTHOCORD DEVICE BROKE WHEN TRYING TO MAKE A KNOT. ACCORDING TO THE REPORT, A SECOND ANCHOR WAS USED BUT THE SAME THING HAPPENED AGAIN LEAVING THE PATIENT WITH NO SPACE FOR A THIRD ANCHOR AND WITHOUT THREADS OR KNOTS TO CLOSE THE DEFECT; AND THEREFORE, THE PATIENT WAS LEFT WITH AN INCOMPLETE REPAIR OF THE ROTATOR CUFF. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17445700 ↗
• InjuryAug 2, 2023Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN COLOMBIA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE SUTURE ON THE 5.5 HEALIX ADVANCE BR ANCHOR WITH ORTHOCORD DEVICE BROKE WHEN TRYING TO MAKE A KNOT. ACCORDING TO THE REPORT, A SECOND ANCHOR WAS USED BUT THE SAME THING HAPPENED AGAIN LEAVING THE PATIENT WITH NO SPACE FOR A THIRD ANCHOR AND WITHOUT THREADS OR KNOTS TO CLOSE THE DEFECT; AND THEREFORE, THE PATIENT WAS LEFT WITH AN INCOMPLETE REPAIR OF THE ROTATOR CUFF. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17444499 ↗