HEALIX ADVANCE 222423Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10886705030583), received between Feb 13, 2020 and May 11, 2026 — classified as 4 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Break” (18 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2026Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE, THE HEALX ADV SP PEEK ANCHOR BROKE. THE SURGEON USED THE DEVICE TO BUILD A BRACE BACKUP, AND THE HOLE WAS DRILLED AT 3.5MM DIAMETER. THE ANCHOR WAS INSERTED TO PUT THE SUTURE INTO THE HOLE. THE SURGEONS WANTED TO ADVANCE THE ANCHOR ITSELF TO SETTLE UPON WHICH THE ANCHOR BROKE. BONE QUALITY WAS AVERAGE. USED ANOTHER DEVICE TO COMPLETE THE CASE. NO SURGICAL DELAY OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25136123 ↗
• MalfunctionNov 19, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR SURGERY, IT WAS OBSERVED THAT WHILE USING THE 4.9MM HEALX ADV SP PEEK ANCHOR DEVICE, THE SURGEON TRIED TO PASS FIVE FIBER WIRE SUTURES THROUGH THE KITES OF THE ANCHOR AND THE KITE LOOPS BROKE. IT WAS REPORTED THAT THE IMPLANT WAS NOT IMPLANTED AND WAS DISCARDED. THERE WAS A THREE MINUTE 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 23595213 ↗
• MalfunctionJul 2, 2024Break; Material Deformation; Break; Material Deformation

  THIS IS REPORT 4 OF 5 FOR (B)(4). IT WAS REPORTED THROUGH CLINICAL RESEARCH THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE, IT WAS OBSERVED THAT THE 4.9MM HEALX ADV SP PEEK ANCHOR DEVICE WAS DEFORMED, WARPED AND DISTORTED THAT LED TO DEVICE BREAKAGE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19657496 ↗
• MalfunctionApr 10, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE 4.9MM HEALX ADV SP PEEK ANCHOR DEVICE SUTURES WOULD NOT PULL THROUGH THE KNOTLESS SELF PUNCHING ANCHOR. THEY GOT STUCK GOING THROUGH THE ANCHOR AND THE KITES BROKE. 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 19077591 ↗
• InjuryAug 31, 2023Break; Break

  THIS IS REPORT 1 OF 5 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THROUGH CLINICAL RESEARCH THAT A PATIENT UNDERWENT AN ARTHROSCOPIC ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE OF THE RIGHT KNEE ON (B)(6) 2023 TREATING AN ACL TEAR. ACCORDING TO THE REPOT, A 4.9MM HEALX ADV SP PEEK ANCHOR DEVICE WAS USED THAT BROKE POSTOPERATIVELY. IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT A RE-OPERATION/REVISION PROCEDURE FOR LOOSE BODY REMOVAL. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17662380 ↗
• MalfunctionJun 28, 2023Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6)2023, IT WAS OBSERVED THAT THE 4.9MM HEALX ADV SP PEEK ANCHOR DEVICE WAS EXTREMELY DIFFICULT TO MOLD DURING INSERTION THEN BENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17220488 ↗
• MalfunctionJun 28, 2023Break; Difficult to Advance; Break; Difficult to Advance

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6)2023, IT WAS OBSERVED THAT THE 4.9MM HEALX ADV SP PEEK ANCHOR DEVICE WAS DIFFICULT TO ADVANCE THEN BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17220487 ↗
• MalfunctionMay 22, 2023Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, A CHIA PERCPASSER SUTURE PASSER AND A 4.9MM HEALX ADV SP PEEK ANCHOR WERE USED TOGETHER. ACCORDING TO THE REPORT, THE ANCHOR KITE WAS PULLED PARTIALLY UP THE ANCHOR BY THE SUTURE PASSER BUT THE KITE BROKE; AND THEREFORE, THE SUTURE PASSER FAILED TO BRING THE SUTURE THROUGH THE ANCHOR. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16978610 ↗
• MalfunctionJan 27, 2023Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE TIPS ON TWO 4.9MM HEALX ADV SP PEEK ANCHOR DEVICES BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16254199 ↗
• MalfunctionJan 27, 2023Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE TIPS ON TWO 4.9MM HEALX ADV SP PEEK ANCHOR DEVICES BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16254196 ↗
• MalfunctionDec 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  INSERTER TIP WAS IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE INSERTER TIP ON THE 4.9MM HEALX ADV SP PEEK ANCHOR DEVICE WAS LOOSE WHEN PACKAGE WAS OPENED. ACCORDING TO THE REPORT, IT FELL OFF BEFORE SURGEON COULD IMPLANT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16017874 ↗
• MalfunctionSep 9, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE 4.9MM HEALX ADV SP PEEK ANCHOR BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15396195 ↗
• MalfunctionJul 18, 2022Degraded; Mechanical Problem; Device-Device Incompatibility; Material Twisted/Bent; Degraded; Mechanical Problem; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT ANCHOR COULD NOT BE RELEASED FROM THE INSERTER. DURING AN IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE WAS STRIPPED/DAMAGED/WORN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15043484 ↗
• MalfunctionApr 13, 2022Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6)2022 IT WAS OBSERVED THAT THE 4.9MM HEALX ADV SP PEEK ANCHOR DEVICE WOULD NOT ADVANCE WHILE BEING SCREWED IN. IT WAS FURTHER REPORTED THAT THE DEVICE HAD A BENT DISTAL METAL TIP. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14106302 ↗
• MalfunctionApr 13, 2022Material Deformation; Component Misassembled; Material Deformation; Component Misassembled

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE BLUE TAB AND KITE WERE COMPLETELY SEPARATED FROM THE ANCHOR AND THE KITE WAS ODDLY CURVED UP ON THE 4.9MM HEALX ADV SP PEEK ANCHOR DEVICE. THE KITE WAS NOT ABLE TO BE RE-SHUTTLED THROUGH THE ANCHOR. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14106212 ↗
• MalfunctionApr 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE 4.9MM HEALX ADV SP PEEK ANCHOR DEVICE WAS NOT IMPLANTED DUE TO PROBLEMS PRIOR TO INSERTION. ACCORDING TO THE REPORT, THE DISTAL PEEK TIP WAS OFF THE METAL TIP AND ANCHOR BODY WAS NOT STAYING ON THE INSERTER. 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 14046580 ↗
• MalfunctionFeb 18, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE WIRE THREADER ON THE 4.9MM HEALX ADV SP PEEK ANCHOR DEVICE BROKE WHILE LOADING THE SUTURES. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13560020 ↗
• MalfunctionJan 6, 2022Migration; Migration

  IT WAS REPORTED BY SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE 4.9MM HEALX ADV SP PEEK ANCHOR POPPED OUT OF THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13176167 ↗
• MalfunctionJan 6, 2022Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE 4.9MM HEALX ADV SP PEEK ANCHOR BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13176122 ↗
• MalfunctionNov 11, 2021Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE 4.9MM HEALX ADV SP PEEK ANCHOR DEVICE BROKE AND THE INSERTER BENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12797735 ↗
• MalfunctionOct 28, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE 4.9MM HEALX ADV SP PEEK ANCHOR DEVICE MALFUNCTIONED WHILE PULLING THE SUTURES THROUGH IT. ACCORDING TO THE REPORT, THREE #2 STITCHES WITH ONE STITCH (FIBER LINK) WERE BEING PULLED IN THE PROXIMAL KITE AND TWO IN THE DISTAL KITE. IT WAS REPORTED THAT THE SECOND KITE SNAPPED IN THE ANCHOR AND THEY COULD NOT REMOVE IT FROM THE ANCHOR. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH LESS THAN 30 MINUTES OF DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12714344 ↗
• MalfunctionApr 27, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE FIBER PLATE ON THE 4.9MM HEALX ADV SP PEEK ANCHOR DEVICE BROKE. ACCORDING TO THE REPORT, THE PATIENT HAD A HARD BONE. THE ANCHOR AND SUTURE WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11733512 ↗
• MalfunctionApr 16, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT AN ANCHOR DEVICE BROKE UPON INSERTION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF FIVE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11679665 ↗
• MalfunctionFeb 18, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE TIP ON THE 4.9MM HEALX ADV SP PEEK ANCHOR DEVICE BROKE DURING INSERTION. ALL FRAGMENTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11344646 ↗
• InjuryDec 28, 2020Migration; Migration

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT A 4.9MM HEALX ADV SP PEEK ANCHOR DEVICE STOPPED ADVANCING AND PULLED OUT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11077576 ↗