HEALIX ADVANCE ORTHOCORD 222304Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10886705021406), received between Apr 25, 2018 and Mar 6, 2024 — classified as 7 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Break” (19 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2024Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  IT WAS REPORTED BY THE SALES REP FROM CHINA THAT DURING A ROTATOR CUFF REPAIR UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024 IT WAS OBSERVED THAT AFTER THE PACKAGING WAS OPENED OF THE 4.5 HEALIX ADVANCE PEEK DEVICE THE ANCHOR WAS DEFORMED. AND WHEN INSERTED THE ANCHOR BROKE OFF. 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 18847072 ↗
• MalfunctionFeb 28, 2024Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A ROATATOR CUFF REPAIR PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT THE 4.5 HEALIX ADVANCE PEEK 3-SUTURE ANCHOR W/ ORTHOCORD DEVICE SUTURE WAS BROKEN OFF WHEN THE SUTURE WAS TIGHTENED. 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 18796025 ↗
• MalfunctionJan 4, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2023 THE HEALIX ADVANCE PEEK DEVICE SUTURE BROKE. 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 18442933 ↗
• MalfunctionJan 4, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE ON (B)(6) 2023 THE HEALIX ADVANCE PEEK DEVICE SUTURE BROKE WHEN TIGHTENED. 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 18442889 ↗
• MalfunctionNov 7, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE SALES REP IN AUSTRALIA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023 THE 4.5 HEALIX ADVANCE PEEK 3SUT W/OC DEVICE DID NOT DEPLOY PROPERLY. 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 18087027 ↗
• MalfunctionNov 2, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE ON (B)(6) 2023 THE 4.5 HEALIX ADVANCE PEEK 3SUT W/OC DEVICE ANCHOR BROKE OFF. ALL BROKEN PARTS WERE REMOVED. 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 18054931 ↗
• MalfunctionOct 18, 2023Break; Break

  IT WAS REPORTED BY THE HEALTH AUTHORITY IN CHINA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6)23. THE 4.5 HEALIX ADVANCE PEEK 3SUT W/OC DEVICE ANCHOR HAD BROKEN OFF. ALL OF THE BROKEN PART WERE REMOVED. 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 17960616 ↗
• MalfunctionAug 9, 2023Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE SUTURE ON THE 4.5 HEALIX ADVANCE PEEK 3-SUTURE ANCHOR W/ ORTHOCORD DEVICE WAS BROKEN OFF WHEN TIGHTENED. 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 17493875 ↗
• MalfunctionJul 27, 2023Migration; Migration

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A SHOULDER REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE 4.5 HEALIX ADVANCE PEEK 3-SUTURE ANCHOR W/ ORTHOCORD DEVICE PULLED OUT. 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 17406220 ↗
• MalfunctionMar 29, 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 EXPRESSEW III SUTURE PASSER W/O HOOK DEVICE WAS MISFIRING. 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 16639290 ↗
• MalfunctionMar 10, 2023Migration; Migration

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A SHOULDER REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE ANCHOR PULLED OUT WHEN THE SUTURE WAS TIGHTENED ON THE 4.5 HEALIX ADVANCE PEEK 3-SUTURE ANCHOR W/ ORTHOCORD DEVICE. 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 16526084 ↗
• MalfunctionMar 3, 2023Migration; Migration

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A SHOULDER REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE ANCHOR PULLED OUT UPON TIGHTENING THE SUTURE ON THE 4.5 HEALIX ADVANCE PEEK 3-SUTURE ANCHOR W/ ORTHOCORD DEVICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16478800 ↗
• MalfunctionDec 20, 2022Delivered as Unsterile Product; Difficult to Open or Remove Packaging Material; Delivered as Unsterile Product; Difficult to Open or Remove Packaging Material

  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) 2022, IT WAS OBSERVED THAT THE PACKAGING RIPPED WHEN OPENING THE 4.5 HEALIX ADVANCE PEEK 3-SUTURE ANCHOR W/ ORTHOCORD DEVICE THEN THE ANCHOR GOT CONTAMINATED. IT WAS FURTHER REPORTED THAT A HEALIX PEEK 3.4MM (DUAL SUTURE) DEVICE 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 16017442 ↗
• MalfunctionJun 27, 2022Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE SUTURE HAD SO MUCH RESISTANCE WHILE SLIDING THE SUTURE TO TIE A KNOT THAT THE SUTURE BRIDGE/CROSS BAR BROKE CAUSING ALL THE SUTURES TO BECOME UNLOADED FROM THE ANCHOR ON THE 4.5 HEALIX ADVANCE PEEK 3-SUTURE ANCHOR W/ ORTHOCORD DEVICE. THIS IS REPORT 1 OF X FOR (B)(4). ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF LESS THAN 30 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14830205 ↗
• MalfunctionMar 18, 2022Crack; Crack

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE TIP ON THE 4.5 HEALIX ADVANCE PEEK 3SUT W/OC DEVICE CRACKED UPON INSERTION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF HALF A SECOND. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13804593 ↗
• InjurySep 7, 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 DISTAL TIP ON THE 4.5 HEALIX ADVANCE PEEK 3-SUTURE ANCHOR W/ ORTHOCORD DEVICE BROKE OFF WHEN THE ANCHOR WAS FULLY INSERTED. THE FRAGMENTS GENERATED WERE NOT REMOVED. THE STATUS OF THE PATIENT POST-SURGERY WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12432882 ↗
• InjuryJun 28, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE SUTURE FROM 4.5 HEALIX ADVANCE PEEK 3-SUTURE ANCHOR W/ ORTHOCORD DEVICE SNAPPED WHEN SURGEON WAS ATTEMPTING TO TIE SUTURES. THE SURGEON PULLED OUT REMAINING SUTURES AND USED A REPLACEMENT HA ANCHOR INSTEAD TO COMPLETE THE PROCEDURE WITH A DELAY OF THREE MINUTES. THE PC ANCHOR REMAINED IN THE PATIENT WITHOUT ANY SUTURES AND THE REPLACEMENT ANCHOR WAS PLACED WITHIN CLOSE PROXIMITY TO THE ORIGINAL. THE DEVICE IS IMPLANTED AND NOT AVAILABLE FOR EVALUATION. THE STATUS OF THE PATIENT POST-SURGERY WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; Unspecified Tissue Injury

  MAUDE report 12076254 ↗
• MalfunctionMay 27, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE 4.5 HEALIX ADVANCE PEEK 3-SUTURE ANCHOR W/ ORTHOCORD DEVICE BROKE DURING INSERTION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11896263 ↗
• MalfunctionMar 10, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE TIP ON THE ANCHOR DEVICE BROKE UPON INSERTION AT COMMENCEMENT OF TRYING TO TURN IT IN. THERE WAS NO SURGICAL DELAY OR ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11455751 ↗
• InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CLINICAL RESEARCH TEAM THAT THE PHYSICIAN PROVIDED RESULTS FOR A LIST OF PATIENTS USING 4.5 HEALIX ADVANCE PEEK 3SUT W/OC DEVICE. THE SURGERY RELATED COMPLICATIONS FOR PATIENTS WITH MCL INJURY INCLUDE PAIN (20%), INFECTION (0), ANCHOR LOOSENING (0), ANCHOR BREAKAGE (0), SUTURE BREAKAGE (0), POST-OP MCL RUPTURE (0), POST-OP KNEE STIFFNESS (16%), REOPERATION (0),VESSEL INJURY (0), NERVE INJURY (4%). THE SURGERY RELATED COMPLICATIONS FOR PATIENTS WITH LATERAL STABILIZATION INJURY INCLUDE PAIN (33.33%), INFECTION (0), ANCHOR LOOSENING (0), ANCHOR BREAKAGE (0), SUTURE BREAKAGE (0), POST-OP LATERAL LIGAMENT RUPTURE (0), POST-OP ANKLE STIFFNESS (33.33%), REOPERATION (0),VESSEL INJURY (0), NERVE INJURY (0).

  Patient problems: Nerve Damage

  MAUDE report 11454348 ↗
• MalfunctionDec 28, 2020Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE INSERTER OF THE 4.5 HEALIX ADVANCE PEEK 3-SUTURE ANCHOR W/ ORTHOCORD BROKE. ALL FRAGMENTS WERE RETRIEVED. 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 11081710 ↗
• InjuryDec 3, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE DRIVER TIP ON THE END OF THE ANCHOR INSERTER OF A HEALIX ADVANCE PEEK W/ TRIPLE STRAND ORTHOCORD BROKE OFF INSIDE THE ANCHOR AND WAS IMPLANTED INTO THE PATIENT. THE PHYSICIAN STATED THAT THE PATIENT WAS COMPLAINING OF SIGNIFICANT PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 10941491 ↗
• InjuryOct 29, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN UNKNOWN PROCEDURE THE TIP OF THE 4.5 HEALIX ADVANCE PEEK 3-SUTURE ANCHOR W/ORTHOCORD BROKE OFF INSIDE THE PATIENT´S BODY. IT IS UNKNOWN IF THE FRAGMENT WERE RETRIEVED. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE REPORTED THE EVENT OCCURRED DURING A ROTATOR CUFF REPAIR. THE FRAGMENT THAT WAS GENERATED FROM THE BROKEN DEVICE, IT WAS THE HEX DRIVER TIP FROM THE ANCHOR INSERTER THAT BROKE OFF INSIDE THE ANCHOR. IT WAS ALSO REPORTED THE FRAGMENT WAS NOT REMOVED AND THIS WAS DISCOVERED VIA POST-OPERATIVE X-RAYS. THE DEVICE WAS DISCARDED SO IT WILL NOT BE RETURNED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10759341 ↗
• MalfunctionSep 18, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY SALES REP THAT WHILE PERFORMING AN OPEN PROXIMAL BICEPS TENODESIS UTILIZING HEALIX ADVANCE ANCHORS. UPON ATTEMPTING TO INSERT ONE OF THE ANCHORS, THE ANCHOR APPEARED TO STRIP OFF OF THE INSERTER BEFORE IT WAS INSERTED ALL THE WAY, AND THE SURGEON DEEMED THE ANCHOR UNFIT AND REMOVED IT FROM THE BONE. A NEW ANCHOR WAS OPENED AND THE PROCEDURE WENT ON WITHOUT FURTHER DELAY. NO PATIENT HARM OR CONSEQUENCE. THERE WAS A SURGERY DELAY OF 5 MINUTES. NO PATIENT CONSEQUENCES. DEVICE DISCARDED.

  Patient problems: Not Applicable

  MAUDE report 10557464 ↗
• InjuryFeb 4, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR THE INSERTER SHAFT OF THE HEALIX ADVANCE PEEK SUTURE ANCHOR BROKE DURING INSERTION. THE SURGEON WAS NOT ABLE TO LOCATE AND RETRIEVE THE FRAGMENTS OF THE SHAFT. THE REP WAS NOT PRESENT DURING THE CASE AND HE IS NOT AWARE ON ANY ADDITIONAL INTERVENTION AT THIS TIME. THE PROCEDURE WAS COMPLETED WITH THE SAME ANCHOR. THE DEVICE WILL RETURN FOR EVALUATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 9667943 ↗