HEALIX ADVANCE ORTHOCORD 222308Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886705021437), received between Oct 10, 2018 and Feb 2, 2021 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE HEAD OF A 5.5 HEALIX ADVANCE PEEK ANCHOR W/ ORTHOCORD AND NEEDLE DEVICE WAS NOT STABLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A 5 TO 7 MINUTES DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11266930 ↗
• MalfunctionFeb 2, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE HEAD OF A 5.5 HEALIX ADVANCE PEEK ANCHOR W/ ORTHOCORD AND NEEDLE DEVICE WAS NOT STABLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A 5 TO 7 MINUTES DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11266923 ↗
• MalfunctionFeb 2, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE HEAD OF A 5.5 HEALIX ADVANCE PEEK ANCHOR W/ ORTHOCORD AND NEEDLE DEVICE WAS NOT STABLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A 5 TO 7 MINUTES DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11266895 ↗
• MalfunctionFeb 2, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE HEAD OF A 5.5 HEALIX ADVANCE PEEK ANCHOR W/ ORTHOCORD AND NEEDLE DEVICE WAS NOT STABLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A 5 TO 7 MINUTES DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11266886 ↗
• MalfunctionSep 24, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED BY THE SALES REP VIA CST THAT DURING A SHOULDER ARTHROSCOPY ONCE THE 5.5 HEALIX ADVANCE PEEK W/OC&ND WAS PLACED IN THE BONE, THE SPECIALIST USED THE ORTHOCORD SUTURE STRANDS TO REPAIR THE SUPRASPINATUS TENDON. WHILE KNOTTING AND GENERATING TRACTION TO THE VIOLET THREAD, IT BROKE. THE TRACTION EXERTED ON THE THREAD WAS MINIMAL AND NO DETERIORATION OF THE STRAND WAS OBSERVED BY MANIPULATION. THE REPAIR COULD BE DONE WITH THE REMAINING SUTURE THREAD. THE SURGERY TIME WAS NOT EXTENDED DUE TO THE INCIDENT. THERE WERE NO CONSEQUENCES FOR THE PATIENT. THE SPECIALIST AFFIRMS THAT ON SEVERAL OCCASIONS THE ORTHOCORD SUTURE OF THE ANCHORS BREAKS EASILY, SOMETHING THAT IS NOT NORMAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9113010 ↗
• MalfunctionOct 15, 2018Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A GLUTEAL TENDON REPAIR; IT WAS OBSERVED THAT THE HEALIX ADVANCE ANCHOR BROKE ON INSERTION. IT WAS REPORTED THAT THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO 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 Consequences Or Impact To Patient

  MAUDE report 7964661 ↗
• MalfunctionOct 10, 2018Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, WHEN THE SUTURE PASSED THROUGH THE TENDON, IT WAS OBSERVED THAT THE NEEDLE AND SUTURE JUNCTION BROKE ON TWO OF THE NEEDLES ON EACH ANCHOR. IT WAS REPORTED THAT THE BREAKAGE DID NOT RESULT IN A SURGICAL DELAY GREATER THAN THIRTY MINUTES OR AN INABILITY TO COMPLETE THE SURGICAL PROCEDURE AS INTENDED. THE REPORTER STATED THAT THE PATIENT HAD HARD BONE. THERE WAS A SURGICAL DELAY OF THREE MINUTES. THE REPORTER STATED THAT NO PORTION OF THE DEVICE REMAINED IN THE PATIENT. THE REPORTER STATED THAT THE THERE WAS A POTENTIAL THAT THE INSERTION WAS OFF AXIS. THE SAME BONE HOLE WAS USED TO COMPLETE THE SURGICAL PROCEDURE AND NO DEBRIS WAS LEFT IN THE PATIENT. IT WAS REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT¿S OUTCOME POST SURGERY WAS A SUCCESSFUL REPAIR. THE REPORTER STATED THERE WERE NO ADVERSE EVENTS TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7951087 ↗
• MalfunctionOct 10, 2018Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, WHEN THE SUTURE PASSED THROUGH THE TENDON, IT WAS OBSERVED THAT THE NEEDLE AND SUTURE JUNCTION BROKE ON TWO OF THE NEEDLES ON EACH ANCHOR. IT WAS REPORTED THAT THE BREAKAGE DID NOT RESULT IN A SURGICAL DELAY GREATER THAN THIRTY MINUTES OR AN INABILITY TO COMPLETE THE SURGICAL PROCEDURE AS INTENDED. THE REPORTER STATED THAT THE PATIENT HAD HARD BONE. THERE WAS A SURGICAL DELAY OF THREE MINUTES. THE REPORTER STATED THAT NO PORTION OF THE DEVICE REMAINED IN THE PATIENT. THE REPORTER STATED THAT THE THERE WAS A POTENTIAL THAT THE INSERTION WAS OFF AXIS. THE SAME BONE HOLE WAS USED TO COMPLETE THE SURGICAL PROCEDURE AND NO DEBRIS WAS LEFT IN THE PATIENT. IT WAS REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT¿S OUTCOME POST SURGERY WAS A SUCCESSFUL REPAIR. THE REPORTER STATED THERE WERE NO ADVERSE EVENTS TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7951086 ↗