HEALIX ADVANCE 222332Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10886705023493), received between Jul 20, 2018 and Mar 26, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Break

  IT WAS REPORTED THAT DURING SHOULDER ARTHROSCOPY SURGERY, THE HEALIX ADVANCE ANCHOR WAS BROKEN OF. ALL THE BROKEN PARTS WERE REMOVED. CHANGED ANOTHER ONE 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 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698480 ↗
• MalfunctionOct 12, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP IN THE UNITED KINGDOM THAT DURING A AN UNSPECIFIED SURGICAL PROCEDURE, AN UNKNOWN 5.5MM HEALIX ADVANCE KNOTLESS ANCHOR - ORTHOCORD DEVICE SUTURE SNAPPED UPON TIGHTENING. IT WAS ALSO REPORTED THAT DURING THE SAME PROCEDURE AN UNKNOWN 6.6MM HEALIX ADVANCE KNOTLESS ANCHOR DEVICE TIP BROKE. 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. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17922213 ↗
• MalfunctionOct 12, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP IN THE UNITED KINGDOM THAT DURING A AN UNSPECIFIED SURGICAL PROCEDURE, AN UNKNOWN 5.5MM HEALIX ADVANCE KNOTLESS ANCHOR - ORTHOCORD DEVICE SUTURE SNAPPED UPON TIGHTENING. IT WAS ALSO REPORTED THAT DURING THE SAME PROCEDURE AN UNKNOWN 6.6MM HEALIX ADVANCE KNOTLESS ANCHOR DEVICE TIP BROKE. 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. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17921465 ↗
• MalfunctionFeb 18, 2021Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE 6.5 HEALIX ADVANCE KNTLSS BR DEVICE BROKE WHILE THREADING A SUTURE THROUGH THE ANCHOR. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT REPORTED. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11343402 ↗
• MalfunctionDec 28, 2020Difficult to Advance; Difficult to Advance

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A TENDON REPAIR PROCEDURE FOR AN ACHILLES TENDON ON (B)(6) 2020, IT WAS OBSERVED THAT THE ANCHOR DEVICE COULD NOT INSERTED AGAINST A ROBUST BONE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THE DEVICE WAS BRAND NEW AND ITS FIRST USE WHEN THE ISSUE OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11081327 ↗
• MalfunctionDec 18, 2019Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT THIS WAS AN ARCR (ARTHROSCOPIC ROTATOR CUFF REPAIR) TREATING ROTATOR CUFF TEAR, IT WAS OBSERVED THAT THE 6.5MM HEALIX ADVANCE KNOTLESS BR ANCHOR DEVICE CAME OFF WHEN IT MADE CONTACT WITH A CANNULA WHILE TRYING ITS REINSERTION. ACCORDING TO THE REPORT, THE EVENT OCCURRED WHEN THE SURGEON APPLIED BRIDGING TECHNIQUE TO AN INSIDE SUTURE FOR INSERTING THE ANCHOR DEVICE. IT WAS REPORTED THAT AS THE SUTURING FAILED, THE SURGEON RETRACTED THE ANCHOR AND TRIED ITS REINSERTION. THEN, THE ANCHOR CAME OFF WHEN IT HAPPENED TO MAKE CONTACT WITH A CANNULA. IT WAS FURTHER REPORTED THAT THE TIP ON THE DEVICE WAS FOUND TO BE SLIGHTLY DEFORMED. THERE WAS A DELAY OF LESS THAN 30 MINUTES IN THE PROCEDURE. IT WAS REPORTED THAT THE DEVICE WAS ON ITS FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. 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 WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Not Applicable

  MAUDE report 9488660 ↗
• MalfunctionNov 25, 2019Break; Break

  THIS IS REPORT 2 OF 3 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING ROTATOR CUFF REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE TIP OF THE HEALIX ADVANCE KNTLS BR BROKE FROM SUTURES PASSING THROUGH THE ANCHOR. ACCORDING TO THE REPORT, THE EVENT OCCURRED WHEN USING THE DOUBLE KITE PASSING DYNACORD THOUGHT THE ANCHORS. THE PROCEDURE WAS DELAYED BY FIVE MINUTES. ANOTHER ANCHOR WAS OPENED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THE ANCHORS BROKE BEFORE INSERTION AND THEY NEVER ENTERED THE PATIENT. THERE WAS A DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2019. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Not Applicable

  MAUDE report 9369712 ↗
• MalfunctionJan 29, 2019Break; Break

  IT WAS REPORTED THAT THE 6.5 HEALIX ADVANCE FAILED DURING AN UNKNOWN PROCEDURE DUE TO THE SUTURE BRIDGE OF THE ADDITIONAL THREAD OF THE ANCHOR BREAKS AND MAKES THE SUTURE MADE WITH THIS THREAD UNNECESSARY. THIS HAPPENED AS SOON AS THE SURGEON SOLICITS TOO MUCH THE THREAD, OR MAKES A STRONG TENSION. THE CASE WAS COMPLETED USING ANOTHER LIKE DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR TIME DELAYS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8285617 ↗
• MalfunctionJan 28, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE SURGEON INTENDED TO PULL THE SUTURES THROUGH THE ANCHOR, THE TIP OF THE ANCHOR BROKE. THE PATIENT DIDN'T EXPERIENCE ANY ADVERSE EVENT, AND WE COULD PERFORM THE SURGERY WITHOUT ANY FURTHER ISSUE WITH A NEW ANCHOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8282512 ↗
• MalfunctionOct 17, 2018Material Invagination; Material Invagination

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE WHEN PULLING THE SUTURE THROUGH, TWO OF THE REP'S 6.5 HEALIX ADVANCED KNOTLESS BR ANCHORS THE SUTURE CUT THROUGH THE TIP OF THE ANCHORS. THE PROCEDURE WAS COMPLETED WITH A THIRD LIKE DEVICE USING THE SAME BONE HOLE WITH NO PATIENT HARM. THE SALES REP REPORTED THAT THERE WAS A 10 MINUTE DELAY TO THE PROCEDURE TO REMOVE THE ANCHORS EACH TIME AND OPEN NEW ANCHOR EACH TIME. THE SALES REP STATED THAT THE DEVICES WERE DISCARDED BY THE CUSTOMER. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO 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 Consequences Or Impact To Patient

  MAUDE report 7975266 ↗
• MalfunctionOct 17, 2018Material Invagination; Material Invagination

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE WHEN PULLING THE SUTURE THROUGH, TWO OF THE REP'S 6.5 HEALIX ADVANCED KNOTLESS BR ANCHORS THE SUTURE CUT THROUGH THE TIP OF THE ANCHORS. THE PROCEDURE WAS COMPLETED WITH A THIRD LIKE DEVICE USING THE SAME BONE HOLE WITH NO PATIENT HARM. THE SALES REP REPORTED THAT THERE WAS A 10 MINUTE DELAY TO THE PROCEDURE TO REMOVE THE ANCHORS EACH TIME AND OPEN NEW ANCHOR EACH TIME. THE SALES REP STATED THAT THE DEVICES WERE DISCARDED BY THE CUSTOMER. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO 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 Consequences Or Impact To Patient

  MAUDE report 7975264 ↗
• MalfunctionAug 7, 2018Break; Break

  DURING A SHOULDER REPAIR, THE SURGEON WAS PASSING 4X ORTHOCORD SUTURE LIMBS VIA LOADING WIRE THROUGH THE ANCHOR TIP WHEN PART OF THE ANCHOR TIP BROKE OFF. A NEW ANCHOR WAS OPENED, AND PROCEDURE CONTINUED. THERE WAS A TEN (10) MINUTE DELAY IN SURGERY. THERE WAS NO ADVERSE EVENT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7758254 ↗
• MalfunctionJul 20, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  SURGEON HAS NOW USED THE HEALIX ADVANCE KNOTLESS ANCHOR ON EIGHT PATIENTS (17 ANCHORS). WHEN HE HAS GOOD MOBILITY IN THE TENDON TO BE REPAIRED, THE ANCHOR WORKS QUITE WELL. HOWEVER, ON OCCASION HE NEEDS TO MOBILIZE THE TENDON UNDER TENSION IN ORDER TO COMPLETE THE REPAIR. HE COMPLAINS THAT THE ANCHOR DOES NOT PERFORM WELL IN THIS SITUATION. AS THE SUTURES EXIT OUT THE BOTTOM OF THE ANCHOR, WHEN HE TRIES TO TENSION THEM IT CAUSES THE ANCHOR TO BE PULLED OUT OF THE PREPARED HOLE DESPITE HIM PUTTING SIGNIFICANT DOWNWARD PRESSURE ON THE INSERTION HANDLE. IN THIS PROCEDURE, THIS CAUSED THE DISTAL TIP OF ONE ANCHOR TO DEFORM AND IT THEN HAD TO BE REMOVED. ADDITIONALLY, WHEN HE HAD SIX LIMBS OF SUTURES, HE FELT THAT THEY OBSTRUCTED HIS VISION AND HAMPERED DOCKING OF THE ANCHOR TIP INTO THE PREPARED HOLE. SURGEON SUGGESTS THAT THE MANUFACTURER LOOK AT PUTTING A WINDOW NEAR THE DISTAL TIP OF THE ANCHOR, JUST BELOW THE FIRST THREAD, SO THAT THE TIP CAN BE DOCKED INTO THE HOLE SECURELY AND HE CAN THEN TENSION THE SUTURES. ADDITIONALLY, HE DOES NOT USE A CLEAR CANNULA IN THESE CASES, SO THE WHITE DOCKING TAB CANNOT BE USED AS DESIGNED BECAUSE IT TENDS TO TRAMPOLINE OFF THE PATIENTS SKIN. ANOTH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7706899 ↗