HEALIX ADVANCE 222585Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886705030347), received between Mar 7, 2019 and Aug 6, 2025 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2025Break; Material Deformation; Break; Material Deformation

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE SUTURE ON THE 5.5HLX ADV PK ANC-DYNA 3-SUT DEVICE BROKE, AND WHILE INSERTING THE 5.5 HEALIX ADVANCE KNTLS PEEK DEVICE, THE TIP EITHER BROKE OFF OR BECAME BENT. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS SPARE DEVICES WERE AVAILABLE TO COMPLETE THE SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22727655 ↗
• MalfunctionMar 14, 2024Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER ROTATOR CUFF REPAIR SURGICAL PROCEDURE ON (B)(6) 2024 THE 5.5 HEALIX ADVANCE KNTLS PEEK DEVICE ANCHOR WAS BROKEN, WHILE TRY TO TIGHTEN THE SUTURE AND INSERT THE ANCHOR. DEVICE IS NOT AVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18907455 ↗
• MalfunctionDec 6, 2023Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING SHOULDER ROTATOR CUFF REPAIR 5.5 HEALIX ADVANCE KNOTLESSS PEEK ANCHOR WAS BROKEN WHILE INSERTING IT INTO THE CANNULA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18277172 ↗
• InjuryMar 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THROUGH A REVIEW OF A CLINICAL RESEARCH REPORT FOR CLINICAL EVIDENCE ON SAFETY AND PERFORMANCE OF 5.5 HEALIX ADVANCE KNTLS PEEK DEVICE THAT POSTOPERATIVELY TO A ROTATOR CUFF REPAIR PROCEDURE PERFORMED ON AN UNKNOWN DATE IN 2019, A PATIENT HAD A REOPERATION 147 DAYS AFTER THE INITIAL PROCEDURE THAT INCLUDED A LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY DUE TO FULL-THICKNESS RE-TEAR OF THE SUPRASPINATUS AND THEN NEAR FULL-THICKNESS INCOMPLETE TEAR OF THE INFRASPINATUS. ACCORDING TO THE REPORT, THE PATIENT HAD TENDON RE-TEAR 84 DAYS AFTER THE INITIAL PROCEDURE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13969904 ↗
• InjuryMar 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THROUGH A REVIEW OF A CLINICAL RESEARCH REPORT FOR CLINICAL EVIDENCE ON SAFETY AND PERFORMANCE OF 5.5 HEALIX ADVANCE KNTLS PEEK DEVICE THAT POSTOPERATIVELY TO A ROTATOR CUFF REPAIR PROCEDURE PERFORMED ON AN UNKNOWN DATE IN 2019, A PATIENT HAD A REOPERATION 315 DAYS FROM THE INITIAL PROCEDURE THAT INCLUDED A RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY AS THE HEALING AND FUNCTIONAL OUTCOME WERE NOT GOING WELL. ACCORDING TO THE REPORT, THE PATIENT HAD JOINT STIFFNESS 128 DAYS FROM THE INITIAL PROCEDURE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Loss of Range of Motion; Unspecified Tissue Injury

  MAUDE report 13969400 ↗
• MalfunctionMay 12, 2020Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE THE TIP OF THIS 5.5 HEALIX ADVANCE KNOTLESS PEEK BROKE. NO FRAGMENTS GENERATED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE WAS DISCARDED BY THE STAFF. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED THE DEVICE BROKE WHEN PULLING SUTURES THROUGH THE METAL KITE, THE TIP OF THE ANCHOR WAS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10049259 ↗
• MalfunctionSep 26, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A SHOULDER PROCEDURE WHEN THE SURGEON WAS LOADING THE FIRST KITE OF THE 5.5 HEALIX ADVANCE KNOTLESS PEEK ANCHOR, HE LOADED IT WITH TOO MANY SUTURES. WHEN THE SURGEON WENT TO PULL TIGHT THE SUTURES THREW THE KITE, THE SUTURES BECAME STUCK IN THE TUNNEL. IT WAS THE SURGEON FIRST TIME USING THE DEVICE AND THE ISSUE OCCURRED OUTSIDE THE JOINT. THE PROCEDURE WAS COMPLETED BY CUTTING THE SUTURES OFF THE KITE AND OPENING A NEW ANCHOR USING THE SAME BONE HOLE. THERE WAS NO PATIENT CONSEQUENCES OR SURGICAL DELAY TO THE CASE. THE SALES REP STATED THAT THE DEVICE WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9125747 ↗
• MalfunctionSep 26, 2019Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER PROCEDURE WHEN THE SURGEON WAS LOADING THE FIRST KITE OF THE 5.5 HEALIX ADVANCE KNOTLESS PEEK ANCHOR, HE LOADED IT WITH TOO MANY SUTURES. WHEN THE SURGEON WENT TO PULL TIGHT THE SUTURES THREW THE KITE, THE SUTURES BECAME STUCK IN THE TUNNEL. IT WAS THE SURGEON FIRST TIME USING THE DEVICE AND THE ISSUE OCCURRED OUTSIDE THE JOINT. THE PROCEDURE WAS COMPLETED BY CUTTING THE SUTURES OFF THE KITE AND OPENING A NEW ANCHOR USING THE SAME BONE HOLE. THERE WAS NO PATIENT CONSEQUENCES OR SURGICAL DELAY TO THE CASE. THE SALES REP STATED THAT THE DEVICE WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9125683 ↗
• MalfunctionJun 20, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE THE SALES REP'S TWO 5.5 HEALIX ADVANCE KNOTLESS PEEK ANCHORS DISTAL TIPS WERE CHEESEWIRED WHILE LOADING. BOTH ANCHORS WERE LOADED WITH ONE SUTURE OF PERMATAPE AND ONE SUTURE OF ORTHOCORD PER KITE. THE CASE WAS COMPLETED WITH A THIRD LIKE-ANCHOR BY USING A SLIGHTLY DIFFERENT ANGLE. THE SALES REP STATED THAT ONLY ONE BONE HOLE WAS CREATED IN THE PATIENT. THE CASE WAS COMPLETED WITHOUT PATIENT HARM, BUT THERE WAS A TWO MINUTE SURGICAL DELAY TO RELOAD THE ANCHORS. THE ANCHORS ARE RETURNING FOR EVALUATION.

  Patient problems: Not Applicable

  MAUDE report 8717200 ↗
• MalfunctionJun 20, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE THE SALES REP'S TWO 5.5 HEALIX ADVANCE KNOTLESS PEEK ANCHORS DISTAL TIPS WERE CHEESEWIRED WHILE LOADING. BOTH ANCHORS WERE LOADED WITH ONE SUTURE OF PERMATAPE AND ONE SUTURE OF ORTHOCORD PER KITE. THE CASE WAS COMPLETED WITH A THIRD LIKE-ANCHOR BY USING A SLIGHTLY DIFFERENT ANGLE. THE SALES REP STATED THAT ONLY ONE BONE HOLE WAS CREATED IN THE PATIENT. THE CASE WAS COMPLETED WITHOUT PATIENT HARM, BUT THERE WAS A TWO MINUTE SURGICAL DELAY TO RELOAD THE ANCHORS. THE ANCHORS ARE RETURNING FOR EVALUATION.

  Patient problems: Not Applicable

  MAUDE report 8717001 ↗
• MalfunctionMar 14, 2019Crack; Crack

  IT WAS REPORTED BY THE SALES REPRESENTATIVE VIA PHONE THAT DURING A SHOULDER REPAIR PROCEDURE THE SALES REP'S 5.5 HEALIX ADVANCE KNOTLESS ANCHOR PEEK FIRST KITE WAS LOADED AND THEN WHILE LOADING THE SECOND KITE, THE SURGEON USED TOO MANY SUTURES AND CRACKED THE ANCHOR. THE SALES REP STATED THIS OCCURRED OUTSIDE THE PATIENT WITH NO FRAGMENTS CREATED THEREFORE NOTHING FELL INTO THE PATIENT CAVITY. THE CASE WAS COMPLETED WITH ANOTHER LIKE-ANCHOR WITH NO PATIENT HARM OR DELAY. THE ANCHOR WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8421413 ↗
• MalfunctionMar 7, 2019Crack; Crack

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A SHOULDER REPAIR PROCEDURE THE SALES REP'S 5.5 HEALIX ADVANCE KNOTLESS PEEK ANCHOR WAS BEING LOADED WITH SUTURES WHEN THE IMPLANT CRACKED. THE SALES REP STATED THAT THE DOUBLE KITES WERE LOADED WITH TOO MANY SUTURES WHICH CAUSED THE IMPLANT TO CRACK. THE ANCHOR CRACKED OUTSIDE THE PATIENT, THEREFORE THERE WAS NO DEBRIS CREATED IN THE PATIENT CAVITY. THE CASE WAS COMPLETED WITH ANOTHER LIKE-ANCHOR WITH LESS SUTURES. THERE WAS NO PATIENT HARM OR DELAY. THE SALES REP WAS NOT PRESENT AND COULD NOT PROVIDE ANY ADDITIONAL INFORMATION. THE DEVICE WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8401319 ↗