HEALIX ADVANCE BR ANCHOR w/PERMATAPE PERMACORD 222359Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10886705027798), received between Dec 18, 2020 and Sep 25, 2026 — classified as 1 injury, 25 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902591 ↗
• MalfunctionFeb 17, 2026Break

  IT WAS REPORTED THAT DURING ARTHROSCOPIC ROTATOR CUFF REPAIR SURGERY, THE HEALIX AV BR 4.5 TAPE BLUE DEVICE BROKE WHEN THE SURGEON TRIED TO INSERT IT INTO THE BONE TUNNEL AS INSTRUCTED IN THE PROCEDURE MANUAL. NO REMAINS WERE FOUND INSIDE THE BODY, AND THE SURGERY WAS COMPLETED SUCCESSFULLY USING ANOTHER PRODUCT OF THE SAME TYPE. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24369714 ↗
• MalfunctionSep 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY, IT WAS OBSERVED THAT THE HEALIX AV BR 4.5 TAPE BLUE DEVICE ANCHOR FELL OUT. 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 23049041 ↗
• MalfunctionSep 11, 2025Migration; Migration

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGICAL PROCEDURE IT WAS OBSERVED THAT AFTER THE SURGEON INSERTED THE HEALIX AV BR 4.5 TAPE BLUE DEVICE ANCHOR AND MANIPULATED THE SUTURE, THE ANCHOR CAME OUT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. 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 23031409 ↗
• MalfunctionJun 16, 2025Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE THE HEALIX AV BR 4.5 TAPE BLUE DEVICE WAS BEING USED WHEN THE PRODUCT WAS INSERTED INTO THE BONE HOLE AFTER USING DEDICATED INSTRUMENTS IN ACCORDANCE WITH THE ATTACHED INSTRUCTIONS. ALTHOUGH THE QUALITY OF THE BONE MAY HAVE BEEN AN INFLUENCE, THE PRODUCT BROKE WHILE INSERTING THE ANCHOR AND IT WAS NOT POSSIBLE TO INSERT IT INTO THE BONE. THE BROKEN ANCHOR WAS IN A BROKEN STATE AND WAS REMOVED IN ITS ENTIRETY FROM THE BODY. THE SURGERY WAS COMPLETED USING A DIFFERENT PRODUCT. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22210267 ↗
• MalfunctionSep 13, 2024Migration; Migration

  IT WAS REPORTED FROM JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR OF THE HEALIX AV BR 4.5 TAPE BLUE DEVICE WAS INSERTED AFTER THE CREATION OF THE BONY FORAMEN BUT HAD BECOME DISLOCATED. THERE WAS THIRTY-MINUTE DELAY TO THE SURGICAL PROCEDURE. A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT REPORTED. 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 REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20211809 ↗
• MalfunctionAug 28, 2024Break; Break

  IT WAS REPORTED FROM JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE, IT WAS OBSERVED THAT THE IMPLANT ON THE HEALIX AV BR 4.5 TAPE BLUE DEVICE BROKE UPON INSERTION. HOWEVER, SINCE THE IMPLANT WAS FIRMLY FIXED IN THE BONY FORAMEN, IT WAS USED AS IS. THERE WAS PATIENT INVOLVEMENT. 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 20086855 ↗
• MalfunctionJun 12, 2024Crack; Device Damaged Prior to Use; Crack; Device Damaged Prior to Use

  IT WAS REPORTED FROM JAPAN THAT DURING AN UNKNOWN SURGERY, IT WAS OBSERVED THAT THE ANCHOR TIP ON THE HEALIX AV BR 4.5 TAPE BLUE DEVICE APPEARED TO BE CRACKED AFTER OPENING ITS PACKAGE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 19521700 ↗
• MalfunctionMay 23, 2024Crack; Crack

  IT WAS REPORTED FROM JAPAN THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THERE WAS A CRACK AT THE TIP OF THE HEALIX AV BR 4.5 TAPE BLUE ANCHOR DEVICE. IT WAS REPORTED THAT THE SURGEON WITHDREW THE DEVICE BECAUSE OF CONCERN WITH BREAKAGE. 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 19381209 ↗
• MalfunctionApr 3, 2024Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE HEALIX AV BR 4.5 TAPE BLUE DEVICE AFTER AN AWL WAS USED, THE ANCHOR IN QUESTION WAS INSERTED. THE ANCHOR TIP ENTERED THE BONE HOLE AND BROKE IMMEDIATELY AFTER STARTING TO TURN. THERE WERE NO BROKEN PIECES IN THE BODY, AND A NEW ANCHOR WAS USED FOR SURGERY. THE BONE QUALITY WAS NEITHER GOOD OR NOR PARTICULARLY BAD. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19034182 ↗
• MalfunctionDec 19, 2023Crack; Crack

  IT WAS REPORTED BY THE SALES REP IN JAPAN THAT DURING A ROTATOR CUFF REPAIR SURGERY ON AN (B)(6) 2023, IT WAS OBSERVED THAT THE FIBRES OF THE HEALIX AV BR 4.5 TAPE BLUE DEVICE WERE FOUND TO BE FUZZY. ALTHOUGH THE SURGEON WAS ABLE TO USE THE DEVICE, THE CONDITION OF IT WAS REPORTED TO BE WEIRD FROM THE BEGINNING. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18353938 ↗
• MalfunctionNov 6, 2023Material Deformation; Material Deformation

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING A ROTATOR CUFF REPAIR PROCEDURE FOR ROTATOR CUFF TEAR, ON (B)(6) 2023, IT WAS OBSERVED THAT AFTER USING THE 5.5 HEALIX ADVANCE KNTLS BR ON THE SUBSCAPULARIS MUSCLE, IT BROKE WHILE REPAIRING THE SUPRASPINATUS MUSCLE. ACCORDING TO THE REPORTER, THE TIP OF AN AWL FOR ANCHOR MAY HAVE INTERFERED WITH THE 5.5 HEALIX ADVANCE KNTLS BR. IT WAS FURTHER REPORTED THAT THE SURGEON REMOVED THE BROKEN 5.5 HEALIX ADVANCE KNTLS BR AND ALSO REMOVED THE HEALIX AV BR 4.5 TAPE BLUE AS IT WAS INTACT BUT HAD ALREADY BEEN CUT OFF. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A THIRTY MINUTE DELAY IN THE PROCEDURE REPORTED. 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 18072022 ↗
• MalfunctionAug 31, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, A 4.5MM HEALIX ADVANCE¿ BR ANCHOR WITH PERMATAPE¿ SUTURE, BLUE DEVICE WAS USED. ACCORDING TO THE REPORT, THE TAPE CAME OFF FIRST, AND THEN THE SUTURE ALSO CAME OFF AFTER DEPLOYING THE ANCHOR. ACCORDING TO THE REPORT, THE SURGEON HAD SECURED THE TAPE AND SUTURE ON ONE SIDE TO PREVENT THEM FROM COMING OUT TO COMPLETE THE PROCEDURE THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17662524 ↗
• MalfunctionApr 26, 2023Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN SWITZERLAND THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, A 4.5MM HEALIX ADVANCE¿ BR ANCHOR WITH PERMATAPE¿ SUTURE, BLUE DEVICE WAS USED. ACCORDING TO THE REPORT, WHEN THE SUTURE WAS PULLED OUT THROUGH THE CANNULA, AND PLACED INTO A LATERAL ANCHOR (HASP), THE SUTURE WAS RIPPED OUT OF THE ANCHOR. IT WAS REPORTED THAT THE SURGEON DID NOT PULL STRONGLY, THE SUTURE JUST CAME OUT. IT WAS REPORTED THAT THE ANCHOR REMAINED IN THE PATIENT AND THE SURGEON DECIDED NOT TO TAKE IT OUT, SINCE SHE DID NOT WANT TO CREATE ANY FRAGMENTS. 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: Foreign Body In Patient

  MAUDE report 16817629 ↗
• MalfunctionApr 20, 2023Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN SWITZERLAND THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT TWO 4.5MM HEALIX ADVANCE¿ BR ANCHOR WITH PERMATAPE¿ SUTURE, BLUE DEVICES BROKE HORIZONTALLY UPON INSERTION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF 10 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16781043 ↗
• MalfunctionApr 20, 2023Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN SWITZERLAND THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT TWO 4.5MM HEALIX ADVANCE¿ BR ANCHOR WITH PERMATAPE¿ SUTURE, BLUE DEVICES BROKE HORIZONTALLY UPON INSERTION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF 10 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16781038 ↗
• MalfunctionMar 2, 2023Migration; Migration

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT POSTOPERATIVELY TO AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE DISTAL PART ON THE 4.5MM HEALIX ADVANCE¿ BR ANCHOR WITH PERMATAPE¿ SUTURE, BLUE DEVICE CAME OUT THAT WAS CONFIRMED THROUGH CT. 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 16467969 ↗
• MalfunctionDec 30, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE TIP OF THE 4.5MM HEALIX ADVANCE¿ BR ANCHOR WITH PERMATAPE¿ SUTURE, BLUE DEVICE BROKE OFF UPON INSERTION. NO BROKEN FRAGMENTS WERE LEFT IN THE PATIENT¿S BODY. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16080621 ↗
• MalfunctionSep 13, 2022Crack; Crack

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE ANCHOR ON THE 4.5MM HEALIX ADVANCE¿ BR ANCHOR WITH PERMATAPE¿ SUTURE, BLUE DEVICE CRACKED EASILY UPON INSERTION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO FRAGMENT OF THE CRACKED ANCHOR LEFT IN THE PATIENT¿S BODY. 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 15412240 ↗
• MalfunctionJun 8, 2022Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE 4.5MM HEALIX ADVANCE¿ BR ANCHOR WITH PERMATAPE¿ SUTURE, BLUE WAS BROKEN. 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 14635114 ↗
• MalfunctionMar 4, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE THREADS ON THE HEALIX AV BR 4.5 TAPE BLUE DEVICE WAS STRIPPED. 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 13667083 ↗
• InjuryMar 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT POSTOPERATIVELY TO AN ACHILLES REPAIR PROCEDURE PERFORMED ON (B)(6) 2021 USING A HEALIX AV BR 4.5 TAPE WHT/BLUE DEVICE IN TENDON SUTURING FOR TREATING ITS TEAR., THE PATIENT HAD AN INFECTION DUE TO STAPHYLOCOCCUS EPIDERMIDIS ON AN UNKNOWN DATE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 13667009 ↗
• MalfunctionJan 5, 2022Migration; Migration

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2021 TREATING A TEAR IN THE RIGHT SHOULDER, IT WAS OBSERVED THAT THE HEALIX AV BR 5.5 TAPE BLUE ANCHOR DEVICE WAS NOT DEPLOYED IN PLACE UPON INSERTION; AND CAME OFF THE BURR HOLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. WITH LESS THAN 30-MINUTE SURGICAL DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13170648 ↗
• MalfunctionJul 26, 2021Difficult to Advance; Difficult to Advance

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE ANCHOR ATTACHED TO THE HEALIX AV BR 4.5 TAPE BLUE DEVICE DID NOT SMOOTHLY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PRODUCT WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12224633 ↗
• MalfunctionFeb 17, 2021Migration; Migration

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE HEALIX AV BR 4.5 TAPE BLUE ANCHOR DEVICE CAME OUT OF THE BURR HOLE AS THE SURGEON PULLED THE END OF THE TAPE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE DEVICE WAS BRAND NEW AND ITS FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11339578 ↗