HEALIX ADVANCE BR ANCHOR w/PERMATAPE PERMACORD 222360Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10886705027804), received between Apr 12, 2019 and Jun 15, 2026 — classified as 1 injury, 19 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2026Break

  IT WAS REPORTED THE EVENT OCCURRED DURING A TRICEPS BRACHII TENDON REPAIR FOR TRICEPS RUPTURE. WHILE THE ANCHOR WAS INSERTED, IT WAS FOUND THAT THE TIP OF THE SCREW BROKE SLIGHTLY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25505586 ↗
• MalfunctionDec 4, 2025Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT DURING A ARTHROSCOPIC ROTATOR CUFF REPAIR SURGERY, AFTER CREATING A BONE FORAMEN WITH AN AWL, THE SURGEON ATTEMPTED TO INSERT A HEALIX AV BR 4.5 TAPE WHT/BLUE, BUT THE ANCHOR WOULD NOT ADVANCE AND THE DEVICE BROKE. THE FRAGMENTS WERE RETRIEVED. ANOTHER SAME PRODUCT WAS USED WITHOUT ANY PROBLEMS. THE SURGEON ATTEMPTED TO THREAD THE SPECIFIED NUMBER OF SUTURES THROUGH THE 4.9MM HEALX ADV SP BIOC ANCHOR BUT FELT STRONG RESISTANCE. AFTER SOMEHOW MANAGING TO INSERT THE THREAD INTO THE ANCHOR, THE SURGEON OPERATED IT AS USUAL WHEN HE FOUND THAT THE ANCHOR HAD CRACKED, SO IT WOULD NOT BE USED. ANOTHER PRODUCT WAS USED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23720493 ↗
• MalfunctionOct 31, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING AN OPEN ROTATOR CUFF REPAIR (ORCR) SURGICAL PROCEDURE, THE HEALIX AV BR 4.5 TAPE WHT/BLUE ANCHOR DEVICE WAS INSERTED ACCORDING TO PROCEDURE, HOWEVER, THE DEVICE DID NOT STAY IN PLACE AND CAME OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY USING A 5.5MM ANCHOR DEVICE. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THE PATIENT, AND NO SURGICAL DELAY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23437570 ↗
• MalfunctionJul 25, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT AFTER CREATING A BURR HOLE WITH AN AWL, THE SURGEON INSERTED AND TURNED THE ANCHOR ON THE HEALIX AV BR 4.5 TAPE WHT/BLUE DEVICE INTO THE BURR HOLE. DURING THIS PROCESS, THE TIP OF THE ANCHOR CRACKED, RESEMBLING A PEELING ACTION. THE SURGEON THEN USED ANOTHER DEVICE, WHICH OPERATED WITHOUT ANY ISSUES. BECAUSE OF THIS, THE EVENT WAS IDENTIFIED AS A POTENTIAL VULNERABILITY OF THE ORIGINAL DEVICE. THE BROKEN FRAGMENTS OF THE ANCHOR WERE SAFELY REMOVED FROM THE BODY, LEAVING NO FRAGMENTS BEHIND. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22609146 ↗
• MalfunctionJun 25, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS FOUND THAT THE ANCHOR ON THE HEALIX AV BR 4.5 TAPE WHT/BLUE DEVICE WAS INSERTED FOLLOWING THE STANDARD PROCEDURE, BUT THE AWL BROKE DURING TAPPING. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22327053 ↗
• MalfunctionJun 9, 2025Break; Break

  THIS IS REPORT 2 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGICAL PROCEDURE, THE GRYPHON P BR DS ANCHOR W/OC DEVICE CAME OUT ON THE GLENOID SIDE AND THE HELIX DEVICE BROKE ON THE HUMERUS SIDE. THEY WERE REMOVED FROM THE PATIENT'S BODY AND THE SURGEON CONFIRMED THAT NO TRACES REMAINED. 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 22170120 ↗
• MalfunctionMay 2, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE HEALIX AV BR 4.5 TAPE WHT/BLUE DEVICE TIP BROKE. ALTHOUGH THE PATIENT HAD HARD BONE, THE TAP HAD BEEN CUT BEFORE USE AND THE SURGERY WAS CARRIED OUT ACCORDING TO THE RECOMMENDED PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY OR HARM TO THE PATIENT REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21949228 ↗
• MalfunctionNov 4, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR-CUFF REPAIR FOR SHOULDER JOINT PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT THE TIP BROKE OFF THE 4.5MM HEALIX ADVANCE¿ BR ANCHOR WITH PERMATAPE¿ PERMACORD, WHITE/BLUE DEVICE WHEN THE ANCHOR WAS INSERTED INTO THE BONY FORAMEN. ANOTHER LIKE DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE SURGERY. 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 20600045 ↗
• MalfunctionOct 25, 2024Migration; Migration

  IT WAS REPORTED BY THE SALES REP FROM JAPAN THAT DURING AN ARTHROSCOPIC SHOULDER ROTATOR CUFF SURGERY ON SHOULDER JOINT FOR ROTATOR CUFF TEAR ON (B)(6) 2024 THE HEALIX AV BR 4.5 TAPE WHT/BLUE DEVICE ANCHOR WAS PULLED OUT WHEN THE SURGEON CREATED A BONY HOLE WITH AN OAR, INSERTED AN ANCHOR, REMOVED THE INSERTER, AND PULLED THE THREAD TO CONFIRM FIXATION. A DIFFERENT ANCHOR WAS USED, A BONE HOLE WAS CREATED IN A DIFFERENT LOCATION AND INSERTED. THE PRODUCT IN QUESTION COULD NOT BE USED PROPERLY. THERE WAS A THIRTY MINUTE DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20536118 ↗
• MalfunctionJul 12, 2024Break; Noise, Audible; Break; Noise, Audible

  IT WAS REPORTED FROM JAPAN THAT DURING AN ARTRHOSCOPIC ROTATOR CUFF REPAIR PROCEDURE, IT WAS OBSERVED THAT THE ANCHOR TIP ON THE HEALIX AV BR 4.5 TAPE WHT/BLUE DEVICE BROKE OFF WITH A CRACKING SOUND UPON INSERTION INTO THE BONE HOLE. 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 19735546 ↗
• MalfunctionNov 29, 2023Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN UNKNOWN PROCEDURE ON 11/14/2023, IT WAS OBSERVED THAT THETIP BROKE OFF THE 4.5MM HEALIX ADVANCE¿ BR ANCHOR WITH PERMATAPE¿ PERMACORD, WHITE/BLUE DEVICE WHEN THE SURGEON ATTEMPTED TO INSERT THE ANCHOR AFTER MAKING A BURR HOLE WITH AN AWL. ANOTHER LIKE DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE SURGERY. 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 18226975 ↗
• MalfunctionSep 7, 2023Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE TAPE ON THE 4.5MM HEALIX ADVANCE¿ BR ANCHOR WITH PERMATAPE¿ SUTURE, WHITE/BLUE DEVICE SNAPPED WHILE IN USE. 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 17700784 ↗
• MalfunctionMar 31, 2023Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE TIP ON THE 4.5MM HEALIX ADVANCE¿ BR ANCHOR WITH PERMATAPE¿ SUTURE, WHITE/BLUE DEVICE BROKE UPON DEPLOYMENT. 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 16659187 ↗
• MalfunctionMay 25, 2022Crack; Crack

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE TIP ON THE ANCHOR ON THE HEALIX AV BR 4.5 TAPE WHT/BLUE DEVICE CRACKED. NO FRAGMENT WAS LEFT IN THE LESION. 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 14496455 ↗
• 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 WHT/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 13667088 ↗
• 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 13667014 ↗
• MalfunctionJan 5, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A SHOULDER REPAIR SURGERY ON (B)(6) 2021 TREATING GREATER TUBERCLE FRACTURE, IT WAS OBSERVED THAT THE ANCHOR TIP ON THE HEALIX AV BR 4.5 TAPE WHT/BLUE DEVICE CRACKED UPON INSERTION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 13170318 ↗
• MalfunctionMar 1, 2021Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN ARTHROSCOPY ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE TIP ON THE HEALIX AV BR 4.5 TAPE WHT/BLUE ANCHOR DEVICE BROKE UPON INSERTION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH LESS THAN 30 MINUTES OF 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 11394485 ↗
• MalfunctionDec 18, 2020Migration; Migration

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ARTHROSCOPIC ROTATOR CUFF FOR A ROTATOR CUFF TEAR PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE HEALIX AV BR 4.5 TAPE BLUE DEVICE, WHEN THE SURGEON PULLED A SUTURE FROM AN INSERTER. THEN, THE ANCHOR EASILY CAME OFF. HE USED THE 2ND 4.5MM ANCHOR, BUT THE SAME EVENT TOOK PLACE. FINALLY THE PROCEDURE WAS COMPLETED WITH ANOTHER REPLACEMENT (5.5MM) LESS THAN 30-MINUTE SURGICAL DELAY WAS REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11041196 ↗
• MalfunctionApr 12, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA CST THAT DURING AN UNKNOWN PROCEDURE THE 4.5 HEALIX ADVANCE ANCHOR WITH PERMACORD SUTURE, WHITE/BLUE, BROKE WHEN INSERTING INTO THE BONE. IT IS UNKNOWN IF FRAGMENTS WERE GENERATED. THE CASE WAS COMPLETED WITH A NEW ANCHOR WITH NO ISSUES. THERE WAS NO PATIENT HARM OR SURGICAL DELAY. THE DEVICE WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8510445 ↗