ORTHOCORD HEALIX TI 222245Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886705007912), received between Aug 16, 2018 and Apr 29, 2026 — classified as 4 injuries, 8 malfunctions.

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

• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A ROTATOR CUFF REPAIR SURGERY WHERE (2X) 5.5 HEALIX TI ANCHOR W/OCORD DEVICES WERE USED, THE PATIENT EXPERIENCED A LOW-GRADE INFECTION IN THE SHOULDER. IT WAS FURTHER REPORTED THAT THE PATIENT REQUIRED REVISION SURGERY OR HARDWARE REMOVAL. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 25031006 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A ROTATOR CUFF REPAIR SURGERY WHERE (2X) 5.5 HEALIX TI ANCHOR W/OCORD DEVICES WERE USED, THE PATIENT EXPERIENCED A LOW GRADE INFECTION IN THE SHOULDER. IT WAS FURTHER REPORTED THAT THE PATIENT REQUIRED REVISION SURGERY OR HARDWARE REMOVAL. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 25026920 ↗
• MalfunctionAug 30, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP IN CHILE THAT DURING AN SHOULDER REPAIR PROCEDURE ON (B)(6) 2023, A 5.5 HEALIX TI ANCHOR W/ ORTHOCORD DEVICE WAS USED. ACCORDING TO THE REPORT, THE ANCHOR PRESENTED FAILURE DURING USE AS IT WAS CUTTING THE SUTURES INTRAOPERATIVELY. 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 17651897 ↗
• MalfunctionSep 6, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN COLOMBIA THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE SUTURES ON THE 5.5 HEALIX TI ANCHOR W/ ORTHOCORD DEVICE BROKE. 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 15364700 ↗
• MalfunctionDec 2, 2020Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED BY SALES REP VIA COMPLAINT SUBMISSION TOOL THAT DURING A SHOULDER ARTHROSCOPY WHEN OPENING A 5.5 HEALIX TI ANCHOR W/ ORTHOCORD, ITS SUTURES WERE CUT, INSIDE THE ORIGINAL PACKAGING. IT WAS NOT USED IN THE PATIENT. NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED THE CASE WAS COMPLETED WITH ANOTHER AVAILABLE ANCHOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10935227 ↗
• InjuryOct 15, 2019Break; Break

  DEVICE REPORT FROM MITEK COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT DURING AN ARTHROSCOPIC SURGERY, TWO HEALIX TI ANCHOR W/OCORD WERE USED. ON BOTH OCCASIONS THE VIOLET THREADS BURST IN HALF AT THE TIME OF MAKING THE KNOTS; IT WAS NOTED EXAGGERATED FORCE WAS NOT USED. IN THIS WAY THE REPAIR COULD ONLY BE DONE WITH SIMPLE POINTS. TO CONCLUDE THE REPAIR, POINTS WERE MADE SIDE BY SIDE WITH LOOSE SUTURES. AN ADDITIONAL ANCHOR, WHICH WAS READILY AVAILABLE, WAS PLACED IN A NEW BONE HOLE TO COMPLETE THE PROCEDURE. NO ADDITIONAL INTERVENTION IS PLANNED. IT WAS NOTED THAT AN EXPRESSWELL CLAMP AND OPEN GUILLOTINE CUTTER WERE USED WITH PROPER SUTURE MANAGEMENT BY THE SURGEON. THIS REPORT IS FOR A HEALIX ANCHOR. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Injury

  MAUDE report 9191111 ↗
• InjuryOct 15, 2019Break; Break

  DEVICE REPORT FROM MITEK COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT DURING AN ARTHORSCOPIC SURGERY, TWO HEALIX TI ANCHOR W/OCORD WERE USED. ON BOTH OCCASIONS THE VIOLET THREADS BURST IN HALF AT THE TIME OF MAKING THE KNOTS; IT WAS NOTED EXAGGERATED FORCE WAS NOT USED. IN THIS WAY THE REPAIR COULD ONLY BE DONE WITH SIMPLE POINTS. TO CONCLUDE THE REPAIR, POINTS WERE MADE SIDE BY SIDE WITH LOOSE SUTURES. AN ADDITIONAL ANCHOR, WHICH WAS READILY AVAILABLE, WAS PLACED IN A NEW BONE HOLE TO COMPLETE THE PROCEDURE. NO ADDITIONAL INTERVENTION IS PLANNED. IT WAS NOTED THAT AN EXPRESSWELL CLAMP AND OPEN GILLOTINE CUTTER WERE USED WITH PROPER SUTURE MANAGEMENT BY THE SURGEON.THIS REPORT IS FOR A HEALIX ANCHOR. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Injury

  MAUDE report 9191108 ↗
• MalfunctionAug 27, 2019Material Frayed; Material Frayed

  IT WAS REPORTED BY THE AFFILIATE VIA CST THAT AT THE TIME OF KNOTTING THE VIOLET THREADS OF THE HEALIX TI ANCHOR W/O CORD THEY BURST WITHOUT SUPPORTING SIGNIFICANT FORCE. FOR THIS REASON THE SUTURE REMAINS WITH A SINGLE KNOT. IN CONSEQUENCE THE SURGERY WAS DELAYED BUT COMPLETED WITH NO PATIENT CONSEQUENCES. IT WAS FURTHER REPORTED THAT ARTHROSCOPIC PROCEDURE WAS PERFORMED ON (B)(6) 2019. THE SUTURE THAT BURST WAS THE LIGHT PURPLE. THE BREAK OCCURRED IN THE KNOT MADE. THE EXPRESSEW III CLAMP WAS USED DURING PROCEDURE. ORTHOCORD-VIOLET W NEEDLES 12/PK WAS USED TO FINISH SUTURING THE ROTATOR CUFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8937288 ↗
• MalfunctionAug 27, 2019Difficult to Insert; Difficult to Insert

  IT WAS REPORTED BY THE AFFILIATE VIA CST THAT DURING A CUFF REPAIR PROCEDURE THE VIOLET THREAD OF THE HEALIX TI ANCHOR W/O CORD BURST WITHOUT MAKING IT STRONGER. A 20 MINUTES DELAY HAS BEEN REPORTED. THE PROCEDURE HAS BEEN COMPLETED USING A REPLACEMENT DEVICE WITHOUT PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8935682 ↗
• MalfunctionSep 4, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT ONE (1) 5.5 MM HEALIX TI ANCHOR WITH ORTHOCORD SUTURE BROKE DOWN DURING A REFIXATION OF SHOULDER. IT WAS REPORTED TO BE A PRODUCTION ERROR. THE SURGEON COMPLETED THE PROCEDURE USING ANOTHER PIECE, CAUSING A TEN (10) MINUTE SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7844151 ↗
• MalfunctionAug 16, 2018Material Frayed; Material Frayed

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING ROTATOR CUFF REPAIR, IT WAS OBSERVED THAT TWO HEALIX TI ANCHOR, 5.5 MM - W/ORTHOCORD DEVICE WERE BROKEN. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF 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 7788744 ↗
• MalfunctionAug 16, 2018Material Frayed; Material Frayed

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN CHILE THAT DURING ROTATOR CUFF REPAIR, IT WAS OBSERVED THAT TWO HEALIX TI ANCHOR, 5.5 MM - W/ORTHOCORD DEVICE WERE BROKEN. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF 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 7788741 ↗