HEALIX ADVANCE ORTHOCORD 222296Recalls & reported problems

Summary

The FDA's MAUDE database contains 320 adverse event reports that list this exact device (DI 10886705021321), received between Apr 2, 2018 and Sep 16, 2026 — classified as 55 injuries, 265 malfunctions.

The most frequently reported specific device problem is “Break” (207 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 320 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50789142 ↗
• MalfunctionSep 16, 2026Break

  It was reported that during a rotator cuff repair surgical procedure, when using the 4.5 HEALIX ADVANCE BR W/OCORD anchor device it was observed that the anchor was broken off. It was reported that all broken pieces were retrieved. It was reported that the surgeon changed to another 4.5 HEALIX ADVANCE BR W/OCORD anchor device to continue the procedure, and the same problem happened again. It was reported that the surgeon changed to another 4.5 HEALIX ADVANCE BR W/OCORD anchor device to continue the procedure, and it was observed that the same problem happened again. 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.This is report 3 of 3 for PC-(b)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50789136 ↗
• MalfunctionSep 16, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50788476 ↗
• MalfunctionSep 10, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50721995 ↗
• MalfunctionJul 28, 2026Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50058309 ↗
• MalfunctionJun 15, 2026Break

  IT WAS REPORTED THAT DURING ROTATOR CUFF REPAIR SURGERY, THE HEALIX ADVANCE ORTHOCORD 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 25499635 ↗
• MalfunctionMay 13, 2026Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE HEALIX ADVANCE ORTHOCORD DEVICE ANCHOR BROKE 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 REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25164596 ↗
• MalfunctionApr 28, 2026Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT PRIOR TO A ROTATOR CUFF REPAIR SURGICAL PROCEDURE, WHEN THE PACKAGING FOR THE 4.5 HEALIX ADVANCE BR3SUT W/OC ANCHOR DEVICE WAS OPENED, IT WAS OBSERVED THAT THE ANCHOR WAS BROKEN OFF. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25023239 ↗
• MalfunctionApr 9, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE THAT THE 4.5 HEALIX ADVANCE BR3SUT W/OC ANCHOR DEVICE 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 24831326 ↗
• MalfunctionApr 7, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE THAT THE 4.5 HEALIX ADVANCE BR3SUT W/OC ANCHOR DEVICE, THAT THE ANCHOR BROKE. 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 24806014 ↗
• MalfunctionApr 7, 2026Break

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, THE HEALIX ADVANCE ORTHOCORD WAS USED IN THE SAME WAY AS OTHER ANCHORS, BUT IT BROKE AND BECAME UNUSABLE. A DIFFERENT PRODUCT WAS USED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY PROBLEMS. THERE WERE NO REPORTS OF RESIDUAL MATERIAL INSIDE THE BODY. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24802792 ↗
• MalfunctionApr 1, 2026Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE HEALIX ADVANCE ORTHOCORD DEVICE WAS BROKEN (2+ PIECES) : DEVICE WAS FRACTURED. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE HAD AN UNDETERMINED MALFUNCTION. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24757982 ↗
• MalfunctionMar 26, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE THAT THE 4.5 HEALIX ADVANCE BR3SUT W/OC ANCHOR DEVICE, THE ANCHOR WAS BROKEN 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 24700216 ↗
• MalfunctionFeb 6, 2026Break

  IT WAS REPORTED THAT DURING THE ROTATOR CUFF REPAIR PROCEDURE, THAT THE 4.5 HEALIX ADVANCE BR3SUT W/OC ANCHOR DEVICE WAS BROKEN OFF AND 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. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24283296 ↗
• MalfunctionJan 30, 2026Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 4.5 HEALIX ADVANCE BR3SUT W/OC 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 24222657 ↗
• MalfunctionJan 5, 2026Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 4.5 HEALIX ADVANCE BR3SUT W/OC DEVICE ANCHOR WAS BROKEN OFF. ALL BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTS OF DELAY IN 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 23958761 ↗
• MalfunctionNov 19, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE, WHEN USING THE 4.5 HEALIX ADVANCE BR3SUT W/OC ANCHOR DEVICE, IT WAS OBSERVED THAT THE ANCHOR WAS BROKEN OFF. IT WAS REPORTED THAT ALL 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 23594086 ↗
• MalfunctionNov 18, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THIS WAS AN ARTHROSCOPIC ROTATOR CUFF REPAIR ON SHOULDER FOR ROTATOR CUFF TEAR PERFORMED. THE SURGEON CREATED THE BONE FORAMEN WITH AN AWL AS USUAL, USED A TAP, AND THEN ATTEMPTED TO INSERT THE ANCHOR IN QUESTION. HOWEVER, THE ANCHOR DID NOT DEPLOY AND CAME LOOSE, MAKING IT UNUSABLE. THE ANCHORS COULD NOT BE DEPLOYED INTO THE BONE AND ALL CAME OUT, SO THEY WERE REMOVED FROM THE BODY. THE ANCHOR FROM ANOTHER COMPANY WAS THEN USED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. IT WAS THOUGHT THAT THE PATIENT'S BONE QUALITY AND THE WAY THE TAP WAS CUT MIGHT BE THE CAUSE. THERE WAS 30 MINUTES SURGICAL DELAY AND NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23585858 ↗
• MalfunctionNov 17, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE 4.5 HEALIX ADVANCE BR3SUT W/OC 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 23568380 ↗
• MalfunctionNov 3, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, IT WAS OBSERVED THAT THE 4.5 HEALIX ADVANCE BR3SUT W/OC DEVICE 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 23453162 ↗
• MalfunctionNov 3, 2025Crack; Crack

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGICAL PROCEDURE, WHEN THE SURGEON USED THE 4.5 HEALIX ADVANCE BR3SUT W/OC DEVICE, IT WAS OBSERVED THAT THE ANCHOR CRACKED AND COULD NOT BE USED. ANOTHER SIMILAR DEVICE WAS USED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS REPORTED THAT THERE WERE NO PIECES OF THE DEVICE LEFT IN THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT, AND NO SURGICAL DELAY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23445303 ↗
• MalfunctionJul 28, 2025Break; Migration; Break; Migration

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628112 ↗
• MalfunctionJul 28, 2025Break; Migration; Break; Migration

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22627967 ↗
• MalfunctionJul 25, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE 4.5 HEALIX ADVANCE BR3SUT W/OC 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 22608123 ↗
• MalfunctionJul 16, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 4.5 HEALIX ADVANCE BR3SUT W/OC ANCHOR DEVICE WAS BROKEN. 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 22519826 ↗