ORTHOCORD HEALIX TI 222242Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10886705007882), received between Jun 12, 2018 and Sep 4, 2024 — classified as 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2024Break; Break

  IT WAS REPORTED FROM COLOMBIA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SUTURE ON THE 5.5 HEALIX TI ANCHR W/OC +NDLS DEVICE BURST EASILY UPON KNOTTING. 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 20138088 ↗
• MalfunctionJul 27, 2023Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN COLOMBIA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE 5.5 HEALIX TI ANCHOR W/ ORTHOCORD AND NEEDLES DEVICE CAME WITH A FRAYED SUTURE; AND THEREFORE, TRACTION COULD NOT BE MADE BECAUSE THE SUTURE BROKE. 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 17408119 ↗
• MalfunctionApr 13, 2023Material Deformation; Material Deformation

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN COLOMBIA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT TWO 5.5 HEALIX TI ANCHOR W/ ORTHOCORD AND NEEDLES DEVICES WERE IN POOR CONDITION; AND THEREFORE, COULD NOT BE USED. ACCORDING TO THE REPORT, THE DEVICES WERE DEFORMED AND CROOKED THAT THEY COULD NOT PERFORM THE FIXATION. 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 16735170 ↗
• MalfunctionApr 13, 2023Material Deformation; Material Deformation

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN COLOMBIA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT TWO 5.5 HEALIX TI ANCHOR W/ ORTHOCORD AND NEEDLES DEVICES WERE IN POOR CONDITION; AND THEREFORE, COULD NOT BE USED. ACCORDING TO THE REPORT, THE DEVICES WERE DEFORMED AND CROOKED THAT THEY COULD NOT PERFORM THE FIXATION. 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 16735166 ↗
• MalfunctionApr 10, 2023Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN BELGIUM THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE 5.5 HEALIX TI ANCHOR W/ ORTHOCORD AND NEEDLES DEVICE BROKE DURING THE KNOT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. WITH A DELAY OF 60 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16709526 ↗
• MalfunctionNov 23, 2022Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN COLOMBIA THAT DURING AN ORTHOPEDIC PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE 5.5 HEALIX TI ANCHOR W/ ORTHOCORD AND NEEDLES DEVICE BROKE FROM THE STEM UPON INSERTION. 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 15857729 ↗
• MalfunctionAug 2, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN COLOMBIA THAT DURING AN ORTHOPEDIC PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT BOTH THE ANCHOR AND SUTURE ON THE 5.5 HEALIX TI ANCHOR W/ ORTHOCORD AND NEEDLES DEVICE BROKE UPON IMPLANTATION. 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 15150168 ↗
• MalfunctionJun 1, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN COLOMBIA THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE 5.5 HEALIX TI ANCHR W/OC +NDLS DEVICE WAS TORN WHEN TYING INTO A KNOT WITHOUT EXERTING ANY TYPE OF FORCE. 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 14568702 ↗
• MalfunctionJul 27, 2021Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ANKLE PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE SUTURE ON THE 5.5 HEALIX TI ANCHR W/OC +NDLS DEVICE BROKE WHILE TRYING TO MAKE A KNOT. 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 12228835 ↗
• MalfunctionFeb 17, 2021Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING REINSERTION OF THE TENDON IN THE KNEE PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE 5.5 HEALIX TI ANCHR W/OC +NDLS DEVICE BROKE UPON INSERTION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A 20 MINUTE DELAY. THERE WERE NO FRAGMENTS GENERATED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11339133 ↗
• MalfunctionDec 29, 2020Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE 5.5 HEALIX TI ANCHOR W/ ORTHOCORD AND NEEDLES BROKE WHEN TYING THE FIRST KNOT AND WITHOUT PULLING TOO HARD. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A 15 MINUTE DELAY. THERE WERE NO FRAGMENTS GENERATED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11088001 ↗
• MalfunctionJan 22, 2020Failure to Advance; Failure to Advance

  IT WAS REPORTED BY AFFILIATE VIA EMAIL, THAT DURING AN ACHILLES REPAIR, WHEN INSERTING A 5.5 HEALIX TI ANCHOR W/ ORTHOCORD AND NEEDLES, DEVICE HAD ITS HEAD ROLLED, MAKING IT IMPOSSIBLE TO CONTINUE ITS SCREWING. THE PROCEDURE WAS FINISHED WITH A REPLACEMENT. NO SURGICAL DELAY OR PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9617856 ↗
• MalfunctionNov 6, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY FOR THE RIGHT LEG ON (B)(6) 2019, A HEALIX TI ANCHOR BROKE. THE DEVICE BROKE AT THE MOMENT OF STARTING THE INSERTION AND IT BROKE INTO A POINT ANCHOR SCREWDRIVER. THE FRAGMENTS WERE REMOVED AND A BACK UP USED TO COMPLETE THE SURGERY. A 10 MINUTE SURGICAL DELAY WAS NOTED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9285477 ↗
• MalfunctionSep 9, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING AN ACHILLES REPAIR PROCEDURE ON (B)(6) 2019, THE SUTURES BREAK WHEN PULLING SUTURES FOR CLOSURE. THE SURGERY WAS COMPLETED SUCCESSFULLY. SURGICAL DELAY AND PATIENT STATUS ARE UNKNOWN. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8975562 ↗
• MalfunctionSep 9, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING AN ACHILLES REPAIR PROCEDURE ON (B)(6) 2019, THE SUTURES BREAK WHEN PULLING SUTURES FOR CLOSURE. THE SURGERY WAS COMPLETED SUCCESSFULLY. SURGICAL DELAY AND PATIENT STATUS ARE UNKNOWN. THIS IS REPORT 1 OF 1 FOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8975309 ↗
• InjuryJul 8, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE REPORTED THE PROCEDURE WAS NOT AN ARTHROSCOPIC SURGERY. THE AFFILIATE ALSO REPORTED ADDITIONAL INFORMATION IS NOT AVAILABLE .

  Patient problems: No Code Available

  MAUDE report 8769403 ↗
• InjuryJun 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT: NECROSIS OF THE EDGES THROUGH THE WOUND AND SOROSANGUINEOUS SECRETION 3 DAYS AFTER THE INTERVENTION. IT WAS PERFORMED IMMEDIATE CLEANING AND EVERY THREE DAYS CONTINUOUSLY. A RADIOGRAPHIC IMAGE SHOWS THE PRESENCE OF A BLACK HALO. THE SURGEON INDICATES THAT HE WISH TO PERFORM REMOVAL OF THE TITANIUM HEALIX ANCHOR AND REQUESTED MATERIAL FOR REMOVAL OF THE IMPLANT AND ORTHOCORD SUTURE FOR LIGAMENT REPAIR THAT WILL BE NECESSARY AFTER REMOVING THE ANCHOR. PATIENT REQUIRES NEXT INTERVENTION AS SOON AS POSSIBLE. THE PROCEDURE WAS PROLONGED IN 90 MINUTES.

  Patient problems: Foreign Body Reaction; Tissue Damage

  MAUDE report 7593540 ↗