HEALIX ADVANCE 222331Recalls & reported problems

Summary

The FDA's MAUDE database contains 196 adverse event reports that list this exact device (DI 10886705023479), received between Feb 2, 2018 and Sep 29, 2026 — classified as 16 injuries, 180 malfunctions.

The most frequently reported specific device problem is “Break” (152 reports).

1 FDA recall record name this device's identifier.

1 other recall cover devices cleared under the same FDA submission (K130917); they may or may not involve this specific model.

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.

Recalls naming this device

1. Nov 4, 2019Class IITerminated

   Specific product codes and lots of the Mitek HEALIX ADVANCE" Knotless Anchors were manufactured with BIOCRYL" Biocomposite Material instead of BIOCRYL RAPIDE Biocomposite Material. BIOCRYL and BIOCRYL RAPIDE are biocompatible and effective material choices for absorbable, injection-molded sports medicine implant fixation.

   Z-0666-2020 · Root cause: Employee error · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 196 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Material Deformation; Migration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933380 ↗
• MalfunctionSep 29, 2026Material Deformation; Migration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933377 ↗
• MalfunctionSep 23, 2026Break

  It was reported that during a Rotator Cuff Repair surgery, the HEALIX ADVANCE ORTHOCORD anchor was broken off. All the broken parts were removed. Changed to another three HEALIX ADVANCE ORTHOCORDs 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 4 for (b)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867659 ↗
• MalfunctionSep 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50828686 ↗
• MalfunctionSep 14, 2026Break

  It was reported that during an unspecified arthroscopic procedure the 5.5 HEALIX ADVANCE KNTLSS BR anchor device broke. Removed all broken parts. Another device was used to complete the procedure. There was a 15 minute 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 50758501 ↗
• MalfunctionJun 8, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THE 5.5 HEALIX ADVANCE KNTLSS BR ANCHOR 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 25435820 ↗
• MalfunctionMay 27, 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 5.5 HEALIX ADVANCE KNTLSS BR DEVICE BROKE OFF. ALL THE BROKEN PARTS WERE REMOVED. A REPLACEMENT DEVICE WAS USED TO CONTINUE THE SURGERY, BUT THE SAME ISSUE OCCURRED AGAIN. THE SURGERY WAS DELAYED APPROXIMATELY TEN MINUTES. 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 25306029 ↗
• MalfunctionMay 27, 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 5.5 HEALIX ADVANCE KNTLSS BR DEVICE BROKE OFF. ALL THE BROKEN PARTS WERE REMOVED. A REPLACEMENT DEVICE WAS USED TO CONTINUE THE SURGERY, BUT THE SAME ISSUE OCCURRED AGAIN. THE SURGERY WAS DELAYED APPROXIMATELY TEN MINUTES. 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 25305973 ↗
• MalfunctionMay 7, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY, A HEALIX ADVANCE ORTHOCORD ANCHOR WAS BROKEN OFF. ALL THE BROKEN PARTS WERE REMOVED. CHANGED TO A HEALIX ADVANCE TO CONTINUE THE SURGERY, 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 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25110197 ↗
• MalfunctionMay 5, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC KNEE PROCEDURE THE 5.5 HEALIX ADVANCE KNTLSS BR ANCHOR DEVICE 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. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25086409 ↗
• MalfunctionMay 5, 2026Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE 5.5 HEALIX ADVANCE KNTLSS BR DEVICE BROKE OFF. ALL THE BROKEN PARTS WERE REMOVED. A REPLACEMENT GRYPHON P BR DS ANCHOR W/OC DEVICE WAS USED TO CONTINUE THE SURGERY, BUT THE SAME ISSUE OCCURRED AGAIN. THERE WERE NO DELAYS IN 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 25085310 ↗
• MalfunctionMay 4, 2026Break

  THIS IS REPORT 3 OF 3 OF (B)(4). IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY SURGICAL PROCEDURE THE ANCHOR BROKE DURING IMPLANTATION. TWO 5.5 HEALIX ADVANCE KNTLSS BR DEVICES WERE BROKEN OFF. ALL BROKEN PARTS WERE REMOVED. THE OMNISPAN MENISCAL REPAIR 27DEG DEVICE WAS DETACHED FROM THE MENISCUS AFTER DEPLOYMENT. 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 25073195 ↗
• MalfunctionMay 4, 2026Break

  THIS IS REPORT 2 OF 3 OF PC-(B)(4). IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY SURGICAL PROCEDURE THE ANCHOR BROKE DURING IMPLANTATION. TWO 5.5 HEALIX ADVANCE KNTLSS BR DEVICES WERE BROKEN OFF. ALL BROKEN PARTS WERE REMOVED. THE OMNISPAN MENISCAL REPAIR 27DEG DEVICE WAS DETACHED FROM THE MENISCUS AFTER DEPLOYMENT. 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 25073166 ↗
• MalfunctionMay 4, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE THE 5.5 HEALIX ADVANCE KNTLSS BR ANCHOR DEVICE BROKE. ALL THE BROKEN PARTS WERE REMOVED AND ANOTHER DEVICE WAS USED AND ALSO 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. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25071109 ↗
• MalfunctionMay 4, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE THE 5.5 HEALIX ADVANCE KNTLSS BR ANCHOR DEVICE BROKE. ALL THE BROKEN PARTS WERE REMOVED AND ANOTHER DEVICE WAS USED AND ALSO 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. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25070929 ↗
• MalfunctionMay 4, 2026Break

  IT WAS REPORTED THAT DURING ROTATOR CUFF REPAIR SURGERY, THE HEALIX ADVANCE ORTHOCORD ANCHOR WAS BROKEN OFF. ALL THE BROKEN PARTS WERE REMOVED. CHANGED ANOTHER TWO DEVICES, ONE WAS A HEALIX ADVANCE AND A GRYPHON ORTHOCORD 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 25070779 ↗
• MalfunctionMay 1, 2026Break

  IT WAS REPORTED THAT DURING ROTATOR CUFF REPAIR SURGERY, THE HEALIX ADVANCE ANCHOR WAS BROKEN. ALL THE BROKEN PARTS WERE REMOVED. CHANGED ANOTHER HEALIX ADVANCE ANCHOR 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 HAS BEEN PROVIDED. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25058187 ↗
• MalfunctionMay 1, 2026Break

  IT WAS REPORTED THAT DURING ROTATOR CUFF REPAIR SURGERY, THE HEALIX ADVANCE ANCHOR WAS BROKEN. ALL THE BROKEN PARTS WERE REMOVED. CHANGED ANOTHER HEALIX ADVANCE ANCHOR 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 HAS BEEN PROVIDED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25058184 ↗
• MalfunctionApr 30, 2026Break

  IT WAS REPORTED THAT DURING THE ARTHROSCOPY SURGERY WITH A 5.5 HEALIX ADVANCE KNTLSS BR , THE ANCHOR WAS BROKE OFF. THEY REMOVED ALL THE BROKEN PARTS. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT OR PROCEDURE DELAY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25049636 ↗
• MalfunctionApr 23, 2026Break

  THIS IS REPORT 1 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, THE ANCHOR BROKEN OFF ON THE 5.5 HEALIX ADVANCE KNTLSS BR. ALL THE BROKEN PARTS WERE REMOVED. THEY CHANGED TO ANOTHER DEVICE (4.5 HEALIX ADVANCE BR W/OCORD) TO CONTINUE THE SURGERY, BUT THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO DELAYS IN THE SURGICAL 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 24974984 ↗
• MalfunctionApr 16, 2026Crack

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC MENISCAL REPAIR PROCEDURE THAT THE 5.5 HEALIX ADVANCE KNTLSS BR ANCHOR DEVICE CRACKED. 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 24899279 ↗
• MalfunctionApr 2, 2026Break

  IT WAS REPORTED THAT DURING SHOULDER ARTHROSCOPY SURGERY, A HEALIX ADVANCE ANCHOR WAS BROKEN OFF. ALL THE BROKEN PARTS WERE REMOVED. CHANGED TO ANOTHER HEALIX ADVANCE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. A THIRD DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24767023 ↗
• MalfunctionApr 2, 2026Break

  IT WAS REPORTED THAT DURING SHOULDER ARTHROSCOPY SURGERY, A HEALIX ADVANCE ANCHOR WAS BROKEN OFF. ALL THE BROKEN PARTS WERE REMOVED. CHANGED TO ANOTHER HEALIX ADVANCE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. A THIRD DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24766992 ↗
• MalfunctionFeb 6, 2026Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE OF AN UNSPECIFIED JOINT, IT WAS OBSERVED THAT THE MILAGRO ADVANCE SCREW 8X30MM DEVICE WAS BROKEN. THE SURGEON THEN CHANGED TO A 5.5 HEALIX ADVANCE KNTLSS BR ANCHOR DEVICE TO CONTINUE THE PROCEDURE, HOWEVER, THE ANCHOR WAS BROKEN OFF. THE SURGEON CHANGED TO AN OMNISPAN MENISCAL REPAIR 27DEG DEVICE TO CONTINUE THE PROCEDURE, BUT AFTER THE 1ST FIRING, IT WAS OBSERVED THAT TWO PLATES WERE DEPLOYED AT THE SAME TIME. IT WAS REPORTED THAT ALL BROKEN PARTS WERE REMOVED FROM THE PATIENT. IT WAS REPORTED THAT ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24283974 ↗
• MalfunctionFeb 6, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC SURGICAL PROCEDURE, WHILE USING THE 5.5 HEALIX ADVANCE KNTLSS BR ANCHOR DEVICE IT WAS OBSERVED THAT THE ANCHOR WAS BROKEN OFF. IT WAS REPORTED THAT ALL THE BROKEN PARTS WERE REMOVED. IT WAS REPORTED THAT 2X ADDITIONAL 5.5 HEALIX ADVANCE KNTLSS BR ANCHOR DEVICES WERE USED AND THE SAME PROBLEM HAPPENED AGAIN. 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 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24283850 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K130917. One submission often covers many models, so check the product and lot details in each record.

• Z-0665-2020 · Nov 4, 2019 · Terminated
  Healix Knotless ADV BR 4.75 Suture Anchor