HEALIX ADVANCE 222425Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10886705030606), received between Aug 16, 2019 and Sep 11, 2026 — classified as 14 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50740812 ↗
• MalfunctionApr 2, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE THAT THE 5.5MM HEALX ADV SP PEEK ANCHOR DEVICE THE PHYSICIAN WAS UNABLE TO PASS TO ORTHOPEDIC SUTURES USING THE KITE INTO THE ANCHOR BODY. AFTER SEVERAL ATTEMPTS TO PULL THE SUTURES INTO THE KNOTLESS ANCHOR THE WIRE KITE BROKE AND THE IMPLANT WAS DISCARDED. 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 24768948 ↗
• MalfunctionMar 11, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE THE 5.5MM HEALX ADV SP PEEK ANCHOR DEVICE WHEN WE WENT TO GO LOAD THE ANCHOR WITH THREE PERMIT TAPE AND ONE PREMISE SUTURE. LARGE OR SMALL KITE JAMMED ITSELF INTO THE ANCHOR. IT WOULD NOT TO ALLOW THE ANCHOR ITSELF WITH THE SUTURE TO COMPLETE THE REPAIR. WE OPENED UP A SECOND ANCHOR WHICH HAD NO DIFFICULTY LOADING WITH THE SAME EXACT FEATURE WENT ON TO COMPLETE THE REPAIR SUCCESSFULLY. NO SURGICAL DELAY OR PATIENT HARM. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21576033 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 7 OF 8 FOR (B)(4). IT WAS REPORTED THROUGH CLINICAL RESEARCH STUDY THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION WITH LATERAL COLLATERAL LIGAMENT (LCL) REPAIR PROCEDURES ON (B)(6) 2023, A 5.5MM HEALX ADV SP PEEK ANCHOR DEVICE WAS USED. ACCORDING TO THE REPORT, POSTOPERATIVELY ON (B)(6) 2024, THE PATIENT HAD JOINT STIFFNESS WITH REDUCED RANGE OF MOTION. IT WAS REPORTED THAT THE EVENT DID NOT RESULT IN A REOPERATION/REVISION PROCEDURE. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19950465 ↗
• MalfunctionFeb 20, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6)2024 THE 5.5MM HEALX ADV SP PEEK ANCHOR DEVICE ANCHOR GOT STUCK IN THE CANNULA AND HAD TO BE REMOVED. THIS CAUSED THE ANCHOR TO BE UNUSABLE AND IT WAS THUS DISCARDED. A SIMILAR ANCHOR WAS OPENED AND USED. THERE WAS ABOUT A FIVE MINUTE DELAY IN THE CASE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18741167 ↗
• InjuryNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 3 OF 3 FOR (B)(4). IT WAS REPORTED THAT AFTER A CLINICAL TRIAL ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE, ON /(B)(6) 2023 WITH A RIGIDLOOP ADJUSTABLE CORTICAL DEVICE, 5.5MM HEALX ADV SP PEEK ANCHOR DEVICE AND INTRAFIX ADVANCE BR SCREW 10 X 23 MM W/LG SHEATH DEVICE, THE PATIENT DEVELOPED AN INFECTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 18092427 ↗
• MalfunctionSep 19, 2023Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE 5.5MM HEALX ADV SP PEEK ANCHOR DEVICE BROKE IN HALF ON THE SHAFT. 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 17774524 ↗
• MalfunctionAug 31, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY SALES REP THAT WHEN 5.5MM HEALX ADV SP PEEK ANCHOR WAS TAKEN OUT OF PACKAGING, THE TIP OF THE ANCHOR FELL RIGHT OFF OF THE HANDLE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17664619 ↗
• MalfunctionAug 15, 2023Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE 5.5MM HEALX ADV SP PEEK ANCHOR DEVICE DID NOT WORK AS EXPECTED. ACCORDING TO THE REPORT, THE METAL INTERNAL SHAFT BROKE THROUGH THE DILATOR TIP. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A THREE MINUTE DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17549449 ↗
• MalfunctionFeb 1, 2023Break; Break

  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 WIRE KITES ON TWO 5.5MM HEALX ADV SP PEEK ANCHOR DEVICES BROKE WHILE THE SURGEON ATTEMPTED TO PULL THE DYNACORD THROUGH IT. ACCORDING TO THE REPORT, THE SURGEON HAD TO USE A CHIA TO THREAD THROUGH THE ANCHOR AND PULL SUTURES THROUGH. 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 16279533 ↗
• MalfunctionFeb 1, 2023Break; Break

  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 WIRE KITES ON TWO 5.5MM HEALX ADV SP PEEK ANCHOR DEVICES BROKE WHILE THE SURGEON ATTEMPTED TO PULL THE DYNACORD THROUGH IT. ACCORDING TO THE REPORT, THE SURGEON HAD TO USE A CHIA TO THREAD THROUGH THE ANCHOR AND PULL SUTURES THROUGH. 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 16279532 ↗
• MalfunctionDec 28, 2022Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING A ROTATOR CUFF REPAIR OF THE SUBSCAPULARIS PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE A 5.5MM HEALX ADV SP PEEK ANCHOR BROKE DURING INSERTION AND CUT SUTURES. ANCHOR HAD TO BE REMOVED AND A NEW DEVICE WAS OPENED AND USED TO COMPLETE THE PROCEDURE WITH A 15 MINUTE DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16061453 ↗
• MalfunctionDec 22, 2022Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING A SHOULDER SCOPE ON (B)(6) 2022, IT WAS OBSERVED THAT THE 5.5MM HEALX ADV SP PEEK ANCHOR DEVICE WAS CRACKED IN HALF AND WAS NOT SET IN BONE. ACCORDING TO THE REPORT, THEY NOTICED CRACK BEFORE GOING TOO FAR WITH THE IMPLANT AND WERE ABLE TO TAKE OUT SHOULDER BUT DILATION TIP WAS IN BONE AND WAS LEFT THERE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16038582 ↗
• MalfunctionOct 25, 2022Difficult to Advance; Difficult to Advance

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE 5.5MM HEALX ADV SP PEEK ANCHOR DEVICE FAILED TO ADVANCE. 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 15668929 ↗
• MalfunctionSep 22, 2022Difficult to Advance; Difficult to Advance

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR ON (B)(6) 2022, IT WAS OBSERVED THAT THE SUTURE TAILS ON THE 5.5MM HEALX ADV SP PEEK ANCHOR DEVICE WERE STUCK IN THE SHAFT. 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 15462796 ↗
• MalfunctionApr 22, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE PEEL TIP ON THE 5.5MM HEALX ADV SP PEEK ANCHOR DEVICE CAME OFF WHEN MALLETING. 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 14187252 ↗
• 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 5.5MM HEALX ADV SP PEEK ANCHOR DEVICE THAT POSTOPERATIVELY TO A ROTATOR CUFF REPAIR PROCEDURE PERFORMED ON AN UNKNOWN DATE IN 2019, A PATIENT HAD A REVISION 539 DAYS AFTER THE INITIAL PROCEDURE THAT INCLUDED SUPERIOR CAPSULAR RECONSTRUCTION OF THE SUPRASPINATUS CAPSULE WITH TENSOR FASCIA LATA AUTOGRAFT DUE TO SUPRASPINATUS TEAR. ACCORDING TO THE REPORT, THE PATIENT HAD LOOSENING OF THE GRAFT 279 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 13970828 ↗
• 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 5.5MM HEALX ADV SP PEEK ANCHOR DEVICE THAT POSTOPERATIVELY TO A ROTATOR CUFF REPAIR PROCEDURE PERFORMED ON AN UNKNOWN DATE IN 2019, A PATIENT HAD A REVISION 306 DAYS AFTER THE INITIAL PROCEDURE THAT INCLUDED LYSIS OF ADHESIONS DUE TO LYSIS OF ADHESIONS FOR RIGHT SHOULDER ARTHROFIBROSIS. ACCORDING TO THE REPORT, THE PATIENT HAD JOINT STIFFNESS 48 DAYS AFTER 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 13970617 ↗
• 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 5.5MM HEALX ADV SP PEEK ANCHOR DEVICE THAT POSTOPERATIVELY TO A ROTATOR CUFF REPAIR PROCEDURE PERFORMED ON AN UNKNOWN DATE IN 2020, A PATIENT HAD A REVISION 49 DAYS AFTER THE INITIAL PROCEDURE THAT INCLUDED IRRIGATION, DEBRIDEMENT, AND REMOVAL OF HARDWARE DUE TO POSTOPERATIVE INFECTION IN THE RIGHT SHOULDER. ACCORDING TO THE REPORT, THE PATIENT HAD THE INFECTION 38 DAYS AFTER THE INITIAL PROCEDURE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 13970314 ↗
• 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 5.5MM HEALX ADV SP PEEK ANCHOR DEVICE THAT POSTOPERATIVELY TO A ROTATOR CUFF REPAIR PROCEDURE PERFORMED ON AN UNKNOWN DATE IN 2019, A PATIENT HAD A REOPERATION 129 DAYS AFTER THE INITIAL PROCEDURE THAT INCLUDED IRRIGATION, DEBRIDEMENT, AND OPEN SYNOVECTOMY DUE TO POSTOPERATIVE INFECTION IN THE LEFT SHOULDER. ACCORDING TO THE REPORT, THE PATIENT HAD THE INFECTION AND PAIN 122 DAYS AFTER THE INITIAL PROCEDURE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 13970024 ↗
• 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 5.5MM HEALX ADV SP PEEK ANCHOR DEVICE THAT POSTOPERATIVELY TO A ROTATOR CUFF REPAIR PROCEDURE PERFORMED ON AN UNKNOWN DATE IN 2020, A PATIENT HAD AN INFECTION 50 DAYS AFTER THE INITIAL PROCEDURE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 13968453 ↗
• 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 5.5MM HEALX ADV SP PEEK ANCHOR DEVICE THAT POSTOPERATIVELY TO A ROTATOR CUFF REPAIR PROCEDURE PERFORMED ON AN UNKNOWN DATE IN 2019, A PATIENT HAD A REOPERATION 129 DAYS AFTER THE INITIAL PROCEDURE DUE TO INFECTION THAT INCLUDED IRRIGATION AND DEBRIDEMENT. ACCORDING TO THE REPORT, THE PATIENT HAD AN INFECTION, EDEMA AND PAIN POSTOPERATIVELY TO THE INITIAL PROCEDURE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 13967896 ↗
• MalfunctionMar 8, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE SUTURE ON THE 5.5MM HEALX ADV SP PEEK ANCHOR DEVICE GOT JAMMED AND THEY HAD TO TAKE TWO OF THE DISTAL DYNACORD STRANDS OUT IN ORDER TO SHUTTLE THE 4 PROXIMAL THROUGH. ACCORDING TO THE REPORT, THE EVENT OCCURRED WHILE TRYING TO LOAD SIX TAILS OF DYNACORD (4 SHORT TAILS IN THE PROXIMAL KITE AND 2 SHORT TAILS IN THE DISTAL KITE). WHEN THEY PULLED THE BLUE KITE TO SHUTTLE THE SUTURE THROUGH THE ANCHOR, THE IT WAS A STRUGGLE BUT THEY WERE STILL ABLE TO USE THE ANCHOR. THERE WAS NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13689301 ↗
• MalfunctionFeb 28, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE KITE WAS BENT AT THE BASE UPON OPENING ITS PACKAGE; AND BROKE WHEN ATTEMPTED TO USE. 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 13623325 ↗
• MalfunctionJan 27, 2022Migration; Migration

  IT WAS REPORTED BY SALES REP THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE ANCHOR'S SUTURE PASSING KITE ON THE 5.5MM HEALX ADV SP PEEK ANCHOR DEVICE PULLED OUT OF THE ANCHOR UPON OPENING AND COULD NOT BE REINSERTED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH LESS THAN FIVE 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 13368753 ↗