ORTHOCORD HEALIX TI 222243Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886705007899), received between Jul 11, 2018 and Apr 30, 2021 — classified as 1 injury, 4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ROTATOR CUFF REPAIR PROCEDURE ON (B)(6)2021, IT WAS OBSERVED THAT THE 5.5 HEALIX TI 3 W/ ORTHOCORD DEVICE BROKE. 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 11753035 ↗
• MalfunctionNov 9, 2020Break; Break

  IT WAS REPORTED BY THE SALES REP VIA COMPLAINT SUBMISSION TOOL THAT TWO ORTHOCORD THREADS ON THE 5.5 HEALIX TI 3 ANCOR W/OCORD ARE BROKEN NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED THE LOT NUMBER IS UNKNOWN AND THE DEVICE CANNOT BE RETRIEVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10814329 ↗
• InjuryNov 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FILE IS A REVIEW OF THE FOLLOWING JOURNAL ARTICLE: YAMAKADO, K, ET AL (2019) A PROSPECTIVE RANDOMIZED TRIAL COMPARING SUTURE BRIDGE AND MEDIALLY BASED SINGLE-ROW ROTATOR CUFF REPAIR IN MEDIUM-SIZED SUPRASPINATUS TEARS. ARTHROSCOPY: THE JOURNAL OF ARTHROSCOPIC AND RELATED SURGERY, VOL. 35, PAGES 2803-2813, (USA). THE STUDY EMPHASIZES ON THE COMPARISON OF THE CLINICAL AND IMAGING OUTCOMES BETWEEN THE SUTURE BRIDGE TECHNIQUE (SB) AND THE MEDIALLY BASED SINGLE-ROW TECHNIQUE (MEDSR) IN PATIENTS WITH 1- TO 3-CM TEAR SIZES. THE PATIENTS EVALUATED ON COURSE OF THIS STUDY: 166 PATIENTS. THE ARTICLE DESCRIBES THE FOLLOWING PROCEDURE: ALL PATIENTS WERE EVALUATED PREOPERATIVELY AND POSTOPERATIVELY (AT 12 AND 24 MONTHS) USING THE MODIFIED UNIVERSITY OF CALIFORNIA, LOS ANGELES SCORING SYSTEM; ACTIVE RANGE OF MOTION (FLEXION AND EXTERNAL ROTATION); AND A VISUAL ANALOG SCALE FOR PAIN. HEALING STATUS WAS EXAMINED BY POSTOPERATIVE MAGNETIC RESONANCE IMAGING. THE DEVICES INVOLVED WERE: HEALIX.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 10778028 ↗
• MalfunctionOct 11, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER REPAIR, IT WAS OBSERVED THAT THE BACK OR PROXIMAL END OF THE CUSTOMER'S HEALIX TI ANCHOR 5.5MM WITH 3 SUTURE ORTHOCORD & NEEDLES BROKE OFF DURING INSERTION. THE SALES REP REPORTED THAT THE SURGEON DID NOT DRILL AND JUST USED THE HEALIX PUNCH TO PREPARE THE BONE TUNNEL. THE SALES REP REPORTED THE SURGEON MALLETED THE DISTAL TIP OF THE ANCHOR FURTHER IN AND PLACED ANOTHER SAME TYPE ANCHOR ON TOP TO SECURE IT. THE SALES REP REPORTED THAT THE SURGEON WAS SATISFIED WITH THE FIXATION. THE SALES REP REPORTED THAT THE PATIENT WAS YOUNG AND HAD VERY HARD BONE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7955870 ↗
• MalfunctionJul 11, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE OF THE SHOULDER REPAIR, IT WAS OBSERVED THAT THE BACK OR PROXIMAL END OF THE CUSTOMER'S HEALIX TI ANCHOR 5.5MM WITH 3 SUTURE ORTHOCORD & NEEDLES BROKE OFF DURING INSERTION. THE SALES REP REPORTED THAT THE SURGEON DID NOT DRILL AND JUST USED THE HEALIX PUNCH TO PREPARE THE BONE TUNNEL. THE SALES REP REPORTED THAT THE SURGEON REMOVED THE BROKEN PIECES AND COMPLETED THE PROCEDURE WITH ANOTHER SAME TYPE ANCHOR IN THE SAME BONE HOLE. THE SALES REP REPORTED THAT THE SURGEON WAS SATISFIED WITH THE FIXATION. THE SALES REP REPORTED THAT THE PATIENT WAS YOUNG AND HAD VERY HARD BONE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7677130 ↗