ORTHOCORD HEALIX TI 222253Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886705007998), received between Jan 14, 2019 and Mar 31, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Crack

  THIS IS REPORT 3 OF 3 OF (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE HEALIX ADVANCE ORTHOCORD DEVICE SUTURE BROKE AND FRAYED INTRAOPERATIVELY. THE SURGEON CONTINUED TO USE HEALIX ADVANCE BUT WOULD NOT USE THE ORTHOCORD DEVICE WITH THE WITH PERMACORD. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. 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 24742260 ↗
• MalfunctionFeb 7, 2025Migration; Migration

  IT WAS REPORTED THAT DURING A SHOULDER REPAIR PROCEDURE, IT WAS OBSERVED THAT THE DEVICE PULLED OUT. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21333622 ↗
• MalfunctionOct 31, 2023Break; Detachment of Device or Device Component; Difficult to Advance; Break; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN COLOMBIA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT AT THE TIME OF THREADING THE 4.5 HEALIX TI ANCHOR W/OCORD DEVICE INTO THE BONE, IT REACHED HALFWAY, AND THE ANCHOR STOPPED ROTATING AND ONLY THE STEM BEGAN TO ROTATE. UPON INSPECTION, IT WAS REALIZED THAT THE TIP THAT HELD THE ANCHOR WAS RELEASED FROM THE STEM, CAUSING IT TO DETACH, AND THE TIP REMAINED INSIDE THE PATIENT WITH THE ANCHOR HALFWAY. THERE WAS A DELAY IN THE PROCEDURE; HOWEVER, THE DURATION OF THE DELAY WAS NOT SPECIFIED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18040916 ↗
• MalfunctionOct 12, 2021Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE SUTURE ON THE ANCHOR ON THE 4.5 HEALIX TI ANCHOR W/OCORD DEVICE BROKE AT ONE POINT AND WAS WORN. 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 12615425 ↗
• MalfunctionJul 7, 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 4.5 HEALIX TI ANCHOR W/OCORD ANCHOR DEVICE BROKE. THE PROCEDURE WAS COMPETED WITH AN UNSPECIFIED DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12128067 ↗
• MalfunctionFeb 26, 2021Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THTA DURING A SHOULDER ARTHROSCOPY FOR ROTATOR CUFF REPAIR ON (B)(6) 2021, IT WAS OBSERVED THAT THE WIRE ON THE 4.5 HEALIX TI ANCHOR W/OCORD DEVICE BROKE UPON INSERTION OF THE ANCHOR. 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 11386410 ↗
• MalfunctionFeb 25, 2021Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE TREATING THE ROTATOR CUFF ON (B)(6) 2021, IT WAS OBSERVED THAT THE WIRE ON THE 4.5 HEALIX TI ANCHOR W/OCORD DEVICE BROKE UPON INSERTION. 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 11377888 ↗
• 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 A 4.5 HEALIX TI ANCHOR W/OCORD WAS PLACED IN THE BONE, AFTER THAT THE SPECIALIST USED THE ORTHOCORD SUTURE STRANDS TO REPAIR THE SUBSCAPULARIS MUSCLE. 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 WAS EXTENDED 10 MINUTES DUE TO THE INCIDENT. THERE WERE NO CONSEQUENCES FOR THE PATIENT.

  Patient problems: Not Applicable

  MAUDE report 9113432 ↗
• MalfunctionFeb 1, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE AFFILIATE VIA THE CST TOOL THAT DURING AN UNKNOWN PROCEDURE THE WHITE PART OF THE ANCHOR INSERTER WAS DETACHED FROM THE METAL PART WHEN PULLING AWAY AFTER INSERTING THE ANCHOR. THE SURGEON TRIED TO HAMMER IT AWAY BUT THE WHITE PART DETACHED. THE INSERTER WAS REMOVED WITH PLIERS AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCES. THE AFFILIATE REPORTED A DELAY OF 2 MINUTES. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE ON 01/20/2019 STATING THAT SURGICAL INTERVENTION IS NOT PLANNED AND THE ANCHOR WAS ABLE TO BE INSERTED INTO THE BONE. THERE IS NO DEBRIS LEFT IN THE PATIENT.

  Patient problems: Not Applicable

  MAUDE report 8298140 ↗
• MalfunctionJan 14, 2019Material Frayed; Material Frayed

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A FRACTURE REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE THREAD BROKE WHILE THE SURGEON WAS KNOTTING THE SUTURE ANCHOR. ACCORDING TO THE REPORTER, TWO ANCHORS WERE USED BUT THE SURGEON DID NOT KNOW WHICH THREAD BROKE. IT WAS REPORTED THAT BOTH ANCHORS WERE IMPLANTED. IT WAS REPORTED THAT THE SECOND ANCHOR WAS USED TO COMPLETE THE PROCEDURE WITH A TEN MINUTE DELAY. 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 8243813 ↗
• MalfunctionJan 14, 2019Material Frayed; Material Frayed

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A FRACTURE REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE THREAD BROKE WHILE THE SURGEON WAS KNOTTING THE SUTURE ANCHOR. ACCORDING TO THE REPORTER, TWO ANCHORS WERE USED BUT THE SURGEON DID NOT KNOW WHICH THREAD BROKE. IT WAS REPORTED THAT BOTH ANCHORS WERE IMPLANTED. IT WAS REPORTED THAT THE SECOND ANCHOR WAS USED TO COMPLETE THE PROCEDURE WITH A TEN MINUTE DELAY. 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 8243647 ↗