HEALIX ADVANCE ORTHOCORD 222303Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10886705021390), received between Jul 5, 2017 and Sep 29, 2026 — classified as 1 injury, 47 malfunctions.

The most frequently reported specific device problem is “Break” (28 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 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Migration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933489 ↗
• MalfunctionSep 29, 2026Migration

  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 4.5 HEALIX ADVANCE PEEK W/CORD device pulled out. 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 50933487 ↗
• MalfunctionSep 25, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903505 ↗
• MalfunctionApr 3, 2026Crack

  THIS IS REPORT 2 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE HEALIX ADVANCE ORTHOCORD DEVICE SUTURE BROKE AND FRAYED INTRAOPERATIVELY. THE SURGEON CONTINUED TO USE HEALIX ADVANCE BUT WOULD NOT USE THE ORTHOCORD DEVICE WITH THE PERMACORD. 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 24775420 ↗
• MalfunctionApr 1, 2026Crack

  THIS IS REPORT 1 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE HEALIX ADVANCE ORTHOCORD DEVICE SUTURE BROKE AND FRAYED INTRAOPERATIVELY. THE SURGEON CONTINUED TO USE HEALIX ADVANCE BUT WOULD NOT USE THE ORTHOCORD DEVICE WITH THE WITH PERMACORD. 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 24758570 ↗
• MalfunctionMar 31, 2026Crack

  THIS IS REPORT 2 OF 3 OF (B)(4). IT WAS REPORTED THAT, DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE HEALIX ADVANCE ORTHOCORD DEVICE SUTURE BROKE AND FRAYED INTRAOPERATIVELY. THE SURGEON CONTINUED TO USE HEALIX ADVANCE BUT WOULD NOT USE THE ORTHOCORD DEVICE WITH THE WITH PERMACORD. 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 24742211 ↗
• MalfunctionMar 31, 2026Crack

  THIS IS REPORT 1 OF 3 OF (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE HEALIX ADVANCE ORTHOCORD DEVICE SUTURE BROKE AND FRAYED INTRAOPERATIVELY. THE SURGEON CONTINUED TO USE HEALIX ADVANCE BUT WOULD NOT USE THE ORTHOCORD DEVICE WITH THE WITH PERMACORD. 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 24742180 ↗
• MalfunctionMar 16, 2026Migration

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE THAT THE 4.5 HEALIX ADVANCE PEEK W/CORD ANCHOR DEVICE PULLED OUT. 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 24607209 ↗
• MalfunctionFeb 12, 2026Migration

  IT WAS REPORTED THAT DURING ROTATOR CUFF REPAIR SURGERY, THE ANCHOR WAS PULLED OUT. 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 24320860 ↗
• MalfunctionDec 16, 2025Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, WHEN INSERTING THE 4.5 HEALIX ADVANCE PEEK W/CORD DEVICE ANCHOR, IT WAS OBSERVED THAT THE THREAD OF ANCHOR WAS PEELED AND THE ANCHOR WOULD NOT SCREW IN. 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 23819044 ↗
• MalfunctionDec 10, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE, WHEN INSERTING THE 4.5 HEALIX ADVANCE PEEK W/CORD ANCHOR DEVICE, IT WAS OBSERVED THAT THE ANCHOR 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 23770274 ↗
• MalfunctionNov 5, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY, IT WAS OBSERVED THAT THE SURGEON WAS PASSING SUTURES THROUGH THE ROTATOR CUFF AFTER IMPLANTING ANCHOR AND THE 4.5 HEALIX ADVANCE PEEK W/CORD DEVICE SUTURE BROKE IN HALF. IT WAS REPORTED THAT TENSION WAS FELT ON THE DEVICE AND AND THE SUTURE WAS EASED HOWEVER, THE SUTURE STILL BROKE. ACCORDING TO THE REPORTER, THIS LEAD TO THE SURGEON HAVING ONLY HAVE ONE POINT OF FIXATION VERSUS TWO. IT WAS REPORTED THAT BESIDES THE SUTURE BEING TOO WEAK OR TOO THIN, THE SURGEON DID NOT HAVE ENOUGH SPACE TO PUT A SECOND ANCHOR IN AND THEREFORE, IT POTENTIALLY COMPROMISED THE INTEGRITY OF THE PATIENT'S REPAIR. 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 23475339 ↗
• MalfunctionSep 2, 2025Break; Break

  REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, IT WAS OBSERVED THAT A 4.5 HEALIX ADVANCE PEEK W/CORD DEVICE ANCHOR WAS BROKEN OFF AND ALL THE BROKEN PARTS WERE REMOVED. ACCORDING TO THE REPORTER, A 5.5 HEALIX ADVANCE KNTLSS BR DEVICE ANCHOR WAS ALSO BROKEN OFF AND ALL THE BROKEN PARTS WERE REMOVED. ANOTHER DEVICES 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 22931935 ↗
• MalfunctionJul 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, WHEN THE 4.5 HEALIX ADVANCE PEEK W/CORD ANCHOR DEVICE WAS INSERTED, IT WAS OBSERVED THAT THE SUTURE DETACHED FROM THE ANCHOR. 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 22588873 ↗
• MalfunctionMay 5, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 4.5 HEALIX ADVANCE PEEK W/CORD ANCHOR DEVICE WAS BROKEN. IT WAS REPORTED THAT ALL BROKEN PARTS WERE REMOVED FROM THE PATIENT. IT WAS REPORTED THAT THE SURGEON CHANGED TO ANOTHER 4.5 HEALIX ADVANCE PEEK W/CORD ANCHOR DEVICE AND THE SAME PROBLEM OCCURRED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21962855 ↗
• MalfunctionMay 5, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 4.5 HEALIX ADVANCE PEEK W/CORD ANCHOR DEVICE WAS BROKEN. IT WAS REPORTED THAT ALL BROKEN PARTS WERE REMOVED FROM THE PATIENT. IT WAS REPORTED THAT THE SURGEON CHANGED TO ANOTHER 4.5 HEALIX ADVANCE PEEK W/CORD ANCHOR DEVICE AND THE SAME PROBLEM OCCURRED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21962852 ↗
• MalfunctionFeb 20, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE THE 4.5 HEALIX ADVANCE PEEK W/CORD DEVICE ANCHOR BROKE OFF. ALL BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21426814 ↗
• MalfunctionDec 13, 2024Material Deformation; Appropriate Device Problem Term/Code Not Available; Material Deformation; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE 4.5 HEALIX ADVANCE PEEK W/CORD DEVICE WAS DEFECTIVE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE ANCHOR TIP OF THE DEVICE WAS DEFORMED DUE TO BONE FRICTION WHILE INSERTING. IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2024. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20926311 ↗
• MalfunctionDec 13, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE 4.5 HEALIX ADVANCE PEEK W/CORD DEVICE WAS DEFECTIVE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE ANCHOR TIP OF THE DEVICE WAS DEFORMED DUE TO BONE FRICTION WHILE INSERTING. IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2024. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20926310 ↗
• MalfunctionDec 9, 2024Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, THE 4.5 HEALIX ADVANCE PEEK W/CORD DEVICE ANCHOR WAS BROKEN OFF, 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. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20878838 ↗
• MalfunctionNov 11, 2024Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, THE 4.5 HEALIX ADVANCE PEEK W/CORD WAS BROKEN OFF. 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 20652327 ↗
• MalfunctionSep 4, 2024Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED FROM CHINA THAT DURING A RECONSTRUCTION OF MEDIAL PATELLAR RETINACULUM PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR OF THE 4.5 HEALIX ADVANCE PEEK W/CORD 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 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 20136112 ↗
• MalfunctionSep 4, 2024Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED FROM CHINA THAT DURING A RECONSTRUCTION OF MEDIAL PATELLAR RETINACULUM PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR OF THE 4.5 HEALIX ADVANCE PEEK W/CORD 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 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 20136110 ↗
• MalfunctionAug 27, 2024Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE 4.5 HEALIX ADVANCE PEEK W/CORD DEVICE WAS BEING USED WHEN THE ANCHOR WAS BROKEN OFF. ALL BROKEN PARTS WERE REMOVED. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY AND THE SAME PROBLEM OCCURRED WITH A 2ND 4.5 HEALIX ADVANCE PEEK W/CORD DEVICE. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20077610 ↗
• MalfunctionAug 15, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN HUNGARY THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON AN UNKNOWN DATE THE 4.5 HEALIX ADVANCE PEEK W/CORD DEVICE ANCHOR WAS BROKEN OFF, ALL BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19996488 ↗