HEALIX ADVANCE PERMACORD 223131Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10886705024827), received between Jan 14, 2019 and Aug 7, 2025 — classified as 7 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (8 reports).

1 other recall cover devices cleared under the same FDA submission (K073412, K100012, K133794); they may or may not involve this specific model.

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.

• MalfunctionAug 7, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 5.5 HEALIXADV BR3SUTANC PCORD DEVICE ANCHOR BROKE OFF DURING INSERTION. THE SURGEON STOPPED THE PROCEDURE AND SWITCHED TO ANOTHER DEVICE. 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 22741995 ↗
• InjuryJun 6, 2024Migration; Migration

  IT WAS REPORTED FROM JAPAN THAT DURING AN ARTRHOSCOPIC ROTATOR CUFF REPAIR PROCEDURE, IT WAS OBSERVED THAT THE ANCHOR ON THE 5.5 HEALIXADV BR3SUTANC PCORD DEVICE CAME OFF AFTER IT WAS INSERTED INTO THE HUMERAL HEAD. IT WAS REPORTED THAT THE ANCHOR WAS THEN REMOVED FROM THE BODY, AND ANOTHER ANCHOR WAS INSERTED INTO THE HUMERAL HEAD. THE SUTURE OF THE REMOVED ANCHOR AT THE PROXIMAL PART SLIGHTLY DUG AND TORN. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19477084 ↗
• InjuryJun 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 1 OF 4 FOR (B)(4). IT WAS REPORTED FROM JAPAN THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE PERFORMED SIX MONTHS AGO ON AN UNKNOWN DATE, A 5.5 HEALIXADV BR3SUTANC PCORD WAS USED. ACCORDING TO THE REPORT, AFTER SURGERY, THE PATIENT SUSPECTED OF BEING INFECTED. IT WAS REPORTED THAT THE SUSPECTED INFECTION WAS DISCOVERED THROUGH AN MRI THAT SHOWED THAT THE AREA WHERE THE HEALIX USED WAS WHITE. IT WAS REPORTED THAT THE HOSPITAL WAS CURRENTLY CONFIRMING THE INFECTION. IT WAS REPORTED THAT ALTHOUGH THERE WERE NO BACTERIA, THERE WERE WHITE BLOOD CELLS. IT WAS REPORTED THAT THE PATIENT¿S SYMPTOMS WERE NOT SIGNIFICANT, AND THE CRP READING WAS ABOUT 1.7. IT WAS REPORTED THAT ABOUT 1CC OF JELLY-LIKE SUBSTANCE CAME OUT. IT WAS REPORTED THAT IT WAS UNCLEAR WHETHER THIS SUBSTANCE WAS CAUSED BY INFECTION OR BY AN ABSORPTION OF THE ANCHOR. THE STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Foreign Body Reaction; Unspecified Infection

  MAUDE report 19476560 ↗
• InjuryOct 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 2 OF 6 FOR (B)(4).. IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, A 5.5 HEALIX ADVANCE BR 3SUTURE ANCHOR W/ PERMACORD DEVICE WAS USED. ACCORDING TO THE REPORT, THE MRI THREE MONTHS AFTER SURGERY SHOWED EDEMA AROUND THE ANCHOR AND THE ANCHOR TIP. IT WAS REPORTED THAT ON (B)(6) 2023, POSTOPERATIVE MRI SHOWED SYMPTOMS THAT SUGGEST EDEMA OR BONE RESORPTION IN THE HUMERUS WHERE THE ANCHOR IN QUESTION WAS DEPLOYED. IT WAS REPORTED THAT THE ROTATOR CUFF WAS TORN AGAIN; AND THAT THE SURGEON COMMENTED THAT THERE WAS A POSSIBILITY OF A FOREIGN BODY REACTION, AND SUSPICION OF INFECTION COULD NOT BE DENIED. IT WAS REPORTED THAT ALTHOUGH THERE WAS SOME PAIN, THE LIFT WAS STILL 130 TO 140 DEGREES ONE YEAR AFTER SURGERY COMPARED TO 80 TO 90 DEGREES BEFORE SURGERY. IT WAS REPORTED THAT THE SURGEON DID NOT THINK ABOUT INFECTION BECAUSE THE CRP WAS NOT HIGH; HOWEVER, INFECTION WAS SUSPECTED. THE SURGEON WILL FOLLOW UP THE PATIENT. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body Reaction; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 17872704 ↗
• MalfunctionJun 22, 2023Difficult to Advance; Migration; Difficult to Advance; Migration

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, A 5.5 HEALIX ADVANCE BR 3SUTURE ANCHOR W/ PERMACORD DEVICE WAS USED. ACCORDING TO THE REPORT, THE DEVICE SPUN OUT AROUND THE SECOND THREAD AND COULD NOT BE INSERTED. IT WAS FURTHER REPORTED THAT THE DEVICE CAME OFF AFTER DEPLOYMENT WHEN THE SUTURE ATTACHED TO THE ANCHOR WAS PULLED TO CHECK THE ANCHOR DEPLOYMENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITHIN 30 MINUTES OF DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17186813 ↗
• InjuryDec 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 2 OF 5 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT POSTOPERATIVELY TO AN ARTHROSCOPIC SYNOVECTOMY AND A MINI-OPEN ROTATOR CUFF REPAIR SURGERY PERFORMED ON (B)(6) 2022, THE PATIENT HAD A REOPERATION ON (B)(6) 2022 WHERE TWO 5.5 HEALIX ADVANCE BR 3SUTURE ANCHOR W/ PERMACORD DEVICES WERE REMOVED BY USING AN INSERTER, AND DEBRIDEMENT WAS DONE. IT WAS FURTHER REPORTED THAT THREE VERSALOK ANCHOR WITH THREADER TAB DEVICES REMAINED IN THE PATIENT¿S BODY. ACCORDING TO THE REPORT, SOFT TISSUE, SUTURES, AND ANCHORS WERE SENT FOR CULTURE PROCEDURE BECAUSE IT WAS NOT SURE IF THERE WAS AN INFECTION. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 15923989 ↗
• InjuryDec 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 1 OF 5 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT POSTOPERATIVELY TO AN ARTHROSCOPIC SYNOVECTOMY AND A MINI-OPEN ROTATOR CUFF REPAIR SURGERY PERFORMED ON (B)(6) 2022, THE PATIENT HAD A REOPERATION ON (B)(6) 2022 WHERE TWO 5.5 HEALIX ADVANCE BR 3SUTURE ANCHOR W/ PERMACORD DEVICES WERE REMOVED BY USING AN INSERTER, AND DEBRIDEMENT WAS DONE. IT WAS FURTHER REPORTED THAT THREE VERSALOK ANCHOR WITH THREADER TAB DEVICES REMAINED IN THE PATIENT¿S BODY. ACCORDING TO THE REPORT, SOFT TISSUE, SUTURES, AND ANCHORS WERE SENT FOR CULTURE PROCEDURE BECAUSE IT WAS NOT SURE IF THERE WAS AN INFECTION. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 15923958 ↗
• InjuryNov 2, 2022Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT POSTOPERATIVELY ON (B)(6) 2022 TO THE INITIAL CASE AROUND 4 MONTHS PRIOR, A REVISION ROTATOR CUFF AND BICEPS REPAIR WAS PERFORMED THAT DETERMINED THAT THE ROTATOR CUFF HAD NOT HEALED. ACCORDING TO THE REPORT, THAT BOTH BICEPS AND CUFF FAILED TO HEAL. IT WAS REPORTED THAT THE ANCHOR WAS STILL IN BONE AND SUTURE WAS IN THE TENDON, AND THE KNOT LOOP WAS STILL INTACT BUT LOOSE AND OUTSIDE OF THE ANCHOR BODY. IT WAS REPORTED THAT IT WAS BELIEVED THAT THE EYELIT SUTURE BAR ON THE 5.5 HEALIX ADVANCE BR 3SUTURE ANCHOR W/ PERMACORD DEVICE HAD BROKEN, THUS ALLOWING THE SUTURE TO BE LOOSE BUT KNOT LOOP STILL REMAIN INTACT. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15716879 ↗
• InjuryNov 2, 2022Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT POSTOPERATIVELY ON (B)(6) 2022 TO THE INITIAL CASE AROUND 4 MONTHS PRIOR, A REVISION ROTATOR CUFF AND BICEPS REPAIR WAS PERFORMED THAT DETERMINED THAT THE ROTATOR CUFF HAD NOT HEALED. ACCORDING TO THE REPORT, THAT BOTH BICEPS AND CUFF FAILED TO HEAL. IT WAS REPORTED THAT THE ANCHOR WAS STILL IN BONE AND SUTURE WAS IN THE TENDON, AND THE KNOT LOOP WAS STILL INTACT BUT LOOSE AND OUTSIDE OF THE ANCHOR BODY. IT WAS REPORTED THAT IT WAS BELIEVED THAT THE EYELIT SUTURE BAR ON THE 5.5 HEALIX ADVANCE BR 3SUTURE ANCHOR W/ PERMACORD DEVICE HAD BROKEN, THUS ALLOWING THE SUTURE TO BE LOOSE BUT KNOT LOOP STILL REMAIN INTACT. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15716877 ↗
• MalfunctionJul 7, 2022Crack; Crack

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE GREEN/WHITE SUTURE ON THE 5.5 HEALIX ADVANCE BR 3SUTURE ANCHOR W/ PERMACORD DEVICE FRAYED WHILE TYING. 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 14944547 ↗
• MalfunctionJul 7, 2022Crack; Crack

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE GREEN/WHITE SUTURE ON THE 5.5 HEALIX ADVANCE BR 3SUTURE ANCHOR W/ PERMACORD DEVICE FRAYED WHILE TYING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14944546 ↗
• MalfunctionJul 7, 2022Crack; Crack

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE GREEN/WHITE SUTURE ON THE 5.5 HEALIX ADVANCE BR 3SUTURE ANCHOR W/ PERMACORD DEVICE FRAYED WHILE TYING. 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 14944545 ↗
• MalfunctionJul 7, 2022Crack; Crack

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6)2022, IT WAS OBSERVED THAT THE GREEN/WHITE SUTURE ON THE 5.5 HEALIX ADVANCE BR 3 SUTURE ANCHOR W/ PERMACORD DEVICE FRAYED WHILE TYING. 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 14944541 ↗
• MalfunctionJun 30, 2022Break; Break

  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 5.5 HEALIX ADVANCE BR 3SUTURE ANCHOR W/ PERMACORD DEVICE BROKE OFF WHEN USED AFTER MAKING A PILOT HOLE WITH AN AWL. 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 14878956 ↗
• MalfunctionJun 16, 2022Crack; Crack

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE GREEN/WHITE SUTURE ON THE 5.5 HEALIX ADVANCE BR 3SUTURE ANCHOR W/ PERMACORD DEVICE FRAYED WHILE TYING. 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 14712756 ↗
• MalfunctionApr 22, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN UNKNOWN SURGERY OF THE SHOULDER ON (B)(6) 2022, IT WAS OBSERVED THAT THE SUTURE ON THE 5.5 HEALIXADV BR3SUTANC PCORD DEVICE WAS DIVIDED UPON INSERTION INTO THE PATIENT'S SHOULDER. 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 14187466 ↗
• MalfunctionJul 14, 2021Break; Break

  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 5.5 HEALIXADV BR3SUTANC PCORD BROKE OFF PRIOR TO INSERTION INTO THE SUPRASPINATUS MUSCLE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12167893 ↗
• MalfunctionApr 12, 2021Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE TIP OF THE ANCHOR DEVICE BROKE OFF DURING SUTURING. ANOTHER LIKE DEVICE WAS USED IN THE SAME BONE HOLE TO COMPLETE THE PROCEDURE WITH A DELAY OF ABOUT 30 MINUTES. ALL BROKEN PIECES WERE REMOVED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THE DEVICE WAS BRAND NEW AND ITS FIRST USE WHEN THE ISSUE OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11651386 ↗
• MalfunctionFeb 1, 2021Detachment 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 1/18/2021, IT WAS OBSERVED THAT THE SUTURE USED ON THE 5.5 HEALIXADV BR3SUTANC PCORD DEVICE CAME OFF WHILE THE SURGEON WAS PULLING ON IT DURING SUTURING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE DEVICES WAS BRAND NEW AND ITS FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11259143 ↗
• MalfunctionJan 14, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A SHOULDER REPAIR PROCEDURE THE CUSTOMER'S 5.5 HEALIX ADVANCE THREE-SUTURE ANCHOR WITH PERMACORD TIP BROKE WHILE INSERTING. THE SALES REP STATED THAT THE ANCHOR WAS FULLY REMOVED FROM THE PATIENT USING A GRASPER. THE SALES REP DID NOT KNOW THE BONE QUALITY OF THE PATIENT. THE CASE WAS COMPLETED WITH A LIKE-ANCHOR IN THE SAME BONE HOLE WITH NO PATIENT HARM OR DELAY. THE SALES REP STATED THERE IS NO NEED FOR SURGICAL INTERVENTION. THE DEVICE WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8244036 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K073412, K100012, K133794. One submission often covers many models, so check the product and lot details in each record.

• Z-2208-2011 · Feb 24, 2011 · Terminated
  DePuy Mitek GRYPHON T BR DS Anchor w/ORTHOCORD Product Code: 210811 Gryphon BR Suture Anchors are intended for: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Bic