HEALIX ADVANCE ORTHOCORD 222305Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10886705021413), received between Jul 12, 2018 and Nov 17, 2025 — classified as 5 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, IT WAS OBSERVED THAT THE 5.5 HEALIX ADVANCE PEEK W/OC DEVICE SUTURE BLEW OUT ONCE THE WHITE CADDY HAD BEEN OPENED ON THE ANCHOR. 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 23570094 ↗
• MalfunctionJun 6, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024 THE 5.5 HEALIX ADVANCE PEEK W/OC DEVICE ANCHOR WAS BROKEN OFF. ALL BROKEN PARTS WERE REMOVED. 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 19476996 ↗
• MalfunctionMay 8, 2023Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN ITALY THAT DURING AN ARTHROSCOPIC PROCEDURE TO REINSERT SUPRASPINATUS ON (B)(6) 2023, IT WAS OBSERVED THAT THE 5.5 HEALIX ADVANCE PEEK ANCHOR WITH ORTHOCORD DEVICE WAS LOOSE IN THE PULL OUT PHASE AND THE SUTURE BROKE WHEN TIGHTENED. 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 16891527 ↗
• MalfunctionSep 9, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN (B)(6) THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE SUTURE DETACHED FROM THE ANCHOR ON THE 5.5 HEALIX ADVANCE PEEK ANCHOR WITH ORTHOCORD DEVICE AFTER 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. THIS COMPLAINT INVOLVES X (X) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15391471 ↗
• MalfunctionAug 25, 2022Break; Migration; Break; Migration

  IT WAS REPORTED BY THE AFFILIATE IN GERMANY THAT DURING A SHOULDER REPAIR PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE HANDLE CAME LOOSE WHEN THE ANCHOR ON THE 5.5 HEALIX ADVANCE PEEK ANCHOR WITH ORTHOCORD DEVICE WAS BEING SCREWED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE HANDLE CAP WAS MISSING; AND IT COULD BE DETECTED THAT THE SLOTTED DRIVER WAS OUT OF PLACE FROM THE HANDLE DRIVER. FINALLY, THE SLOTTED CONTROLLER WAS EASILY REMOVED FROM ITS PLACE. 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 15293533 ↗
• MalfunctionJun 26, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED BY THE AFFILIATE VIA PHONE THAT DURING A RIGHT ROTATOR CUFF REPAIR PROCEDURE THE 5.5 HEALIX ADVANCE PEEK ANCHOR WITH ORTHOCORD SUTURE LOOP WAS BROKEN AND COULD NOT FIX THE ANCHOR. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE SURGERY TIME WAS NOT DELAYED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8735705 ↗
• InjuryJun 3, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE REPORTING THAT 3 SUTURES BROKE INTRA-OP WHILE TRYING TO TIE KNOTS WITH HAND TENSION. THE AFFILIATE ALSO REPORTED THAT THE INITIAL SURGICAL PLAN INCLUDED TO USE 4 ANCHORS: 2 FOR SSP AND 2 FOR SSC. 4 ANCHORS WERE USED. IN 3 OUT OF 4 ANCHORS THE VIOLET SUTURE BROKE. NO ADDITIONAL BONE HOLES WERE CREATED DUE TO THE ALLEGED SUTURE BREAK. THERE WERE NO KNOWN PATIENT CONSEQUENCES BUT THE AFFILIATE REPORTED BUT IN THE FUTURE MAYBE AN INSUFFICIENCY OF THE CUFF REPAIR, AS 3 SIMPLE SUTURES HAD TO BE APPLIED, INSTEAD OF MASON-ALLAN-CONFIGURATION.

  Patient problems: Foreign Body In Patient; Injury; No Code Available; Not Applicable

  MAUDE report 8663094 ↗
• InjuryJun 3, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE REPORTING THAT 3 SUTURES BROKE INTRA-OP WHILE TRYING TO TIE KNOTS WITH HAND TENSION. THE AFFILIATE ALSO REPORTED THAT THE INITIAL SURGICAL PLAN INCLUDED TO USE 4 ANCHORS: 2 FOR SSP AND 2 FOR SSC. 4 ANCHORS WERE USED. IN 3 OUT OF 4 ANCHORS THE VIOLET SUTURE BROKE. NO ADDITIONAL BONE HOLES WERE CREATED DUE TO THE ALLEGED SUTURE BREAK. THERE WERE NO KNOWN PATIENT CONSEQUENCES BUT THE AFFILIATE REPORTED BUT IN THE FUTURE MAYBE AN INSUFFICIENCY OF THE CUFF REPAIR, AS 3 SIMPLE SUTURES HAD TO BE APPLIED, INSTEAD OF MASON-ALLAN-CONFIGURATION.

  Patient problems: Foreign Body In Patient; Injury; No Code Available; Not Applicable

  MAUDE report 8662886 ↗
• InjuryJun 3, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE REPORTING THAT 3 SUTURES BROKE INTRA-OP WHILE TRYING TO TIE KNOTS WITH HAND TENSION. THE AFFILIATE ALSO REPORTED THAT THE INITIAL SURGICAL PLAN INCLUDED TO USE 4 ANCHORS: 2 FOR SSP AND 2 FOR SSC. 4 ANCHORS WERE USED. IN 3 OUT OF 4 ANCHORS THE VIOLET SUTURE BROKE. NO ADDITIONAL BONE HOLES WERE CREATED DUE TO THE ALLEGED SUTURE BREAK. THERE WERE NO KNOWN PATIENT CONSEQUENCES BUT THE AFFILIATE REPORTED BUT IN THE FUTURE MAYBE AN INSUFFICIENCY OF THE CUFF REPAIR, AS 3 SIMPLE SUTURES HAD TO BE APPLIED, INSTEAD OF MASON-ALLAN-CONFIGURATION.

  Patient problems: Foreign Body In Patient; Injury; No Code Available; Not Applicable

  MAUDE report 8662884 ↗
• MalfunctionFeb 15, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA CST THAT DURING SURGERY THE 5.5 HEALIX ADVANCE PEEK W/OC ANCHORS BROKEN IN RCR. CASE COMPLETION DETAILS, PATIENT CONSEQUENCES, SURGICAL DELAY ARE UNKNOWN. IT IS UNKNOWN ABOUT THE FRAGMENT GENERATION AND MEDICAL INTERVENTION REQUIREMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8343181 ↗
• MalfunctionFeb 15, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA CST THAT DURING SURGERY THE 5.5 HEALIX ADVANCE PEEK W/OC ANCHORS BROKEN IN RCR. CASE COMPLETION DETAILS, PATIENT CONSEQUENCES, SURGICAL DELAY ARE UNKNOWN. IT IS UNKNOWN ABOUT THE FRAGMENT GENERATION AND MEDICAL INTERVENTION REQUIREMENT. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE ON 2/10/19 STATING REPORTING THAT THE DATE OF THE EVENT WAS (B)(6) 2019 THE AFFILIATE ALSO REPORTED THAT THE IMPLANT BROKE INTO 2 PIECES AND THE PATIENT'S BONE QUALITY WAS SCLEROTIC. IT WAS ALSO REPORTED THAT THE SURGEON WAS POSSIBLY SLIGHTLY OFF - AXIS WHILE INSERTING THE IMPLANT. THE AFFILIATE STATED THAT THE SAME BONE HOLE WAS USED BUT IT WAS RE-PREPARED AND NO DEBRIS WAS LEFT IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8343068 ↗
• InjuryJul 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS PATIENT INFECTION DETECTED POST OP. THE PATIENT CONSEQUENCE WAS INFECTION. THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ARE ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 7719808 ↗
• InjuryJul 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS PATIENT INFECTION DETECTED POST OP. THE PATIENT CONSEQUENCE WAS INFECTION. THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ARE ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 7719786 ↗
• MalfunctionJul 12, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR REPAIR THAT THE CUSTOMER'S HEALIX ADVANCE PEEK 5.5MM ANCHOR BROKE UPON INSERTION. THE SALES REP REPORTED THAT THE ANCHOR THREADS DEFORMED AND FLATTENED OUT AND WOULD NOT FULLY ENGAGE THE BONE. THE LAST 3 THREADS WOULD NOT ADVANCE. THE SALES REP REPORTED THAT THE SURGEON REMOVED THE ANCHOR AND TRIED AGAIN WITH THE SAME TYPE ANCHOR, THIS TIME TAPPING WHICH HE HAD NOT HAD TO DO BEFORE WITH THIS DEVICE. HE SURGEON PREPPED THE HOLE WITH THE GRAY HANDLED HEALIX AWL, PUNCHED DID NOT DRILL FOR BOTH TRIES. THE SALES REP REPORTED THAT THE SURGEON WAS NOT OFF-AXIS. BOTH OF THESE ANCHORS WERE FULLY REMOVED. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER 6.5MM ANCHOR IN THE SAME BONE HOLE WITH NO PATIENT CONSEQUENCES OR DELAY. THE SALES REP REPORTED THAT THE PATIENT WAS FEMALE IN HER FIFTIES WITH HARD BONE QUALITY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7681624 ↗
• MalfunctionJul 12, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR REPAIR THAT THE CUSTOMER'S HEALIX ADVANCE PEEK 5.5MM ANCHOR BROKE UPON INSERTION. THE SALES REP REPORTED THAT THE ANCHOR THREADS DEFORMED AND FLATTENED OUT AND WOULD NOT FULLY ENGAGE THE BONE. THE LAST 3 THREADS WOULD NOT ADVANCE. THE SALES REP REPORTED THAT THE SURGEON REMOVED THE ANCHOR AND TRIED AGAIN WITH THE SAME TYPE ANCHOR, THIS TIME TAPPING WHICH HE HAD NOT HAD TO DO BEFORE WITH THIS DEVICE. HE SURGEON PREPPED THE HOLE WITH THE GRAY HANDLED HEALIX AWL, PUNCHED DID NOT DRILL FOR BOTH TRIES. THE SALES REP REPORTED THAT THE SURGEON WAS NOT OFF-AXIS. BOTH OF THESE ANCHORS WERE FULLY REMOVED. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER 6.5MM ANCHOR IN THE SAME BONE HOLE WITH NO PATIENT CONSEQUENCES OR DELAY. THE SALES REP REPORTED THAT THE PATIENT WAS FEMALE IN HER FIFTIES WITH HARD BONE QUALITY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7681574 ↗