HEALIX ADVANCE ORTHOCORD 222301Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886705021376), received between Jun 29, 2018 and Aug 28, 2024 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• MalfunctionAug 28, 2024Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED BY THE SALES REP IN JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR CUFF TEAR SURGERY FOR SCR PERFORMED ON (B)(6) 2024, IT WAS OBSERVED THAT THE 6.5 HEALIX ADVANCE BR3SUT W/OC DEVICE WAS TO BE INSERTED AFTER THE OWLS, BUT IT WAS NOT INSERTED. ACCORDING TO THE REPORTER, AFTER THE TAP WAS TURNED OFF, THE INSERTION WAS ATTEMPTED AGAIN BUT COULD NOT BE DONE AND THE THREADED PART SEEMED TO BE BROKEN. IT WAS REPORTED THAT THE DEVICE WAS NOT IMPLANTED IN THE PATIENT'S BODY AND WAS DISCARDED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20083533 ↗
• MalfunctionOct 13, 2023Migration; Migration

  T WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR FOR HUMERUS ROTATOR CUFF TEAR ON (B)(6) 2023 WHILE USING THE 6.5 HEALIX ADVANCE KNTLS BR, AND THE 6.5 HEALIX ADVANCE BR3SUT W/OC DEVICES, THE ANCHORS CAME OFF WHEN TENSION WAS APPLIED TO THEM. THERE WAS A 60 MINUTE DELAY IN THE PROCEDURE REPORTED. IT WAS REPORTED THAT THE PATIENT HAD OSTEOPOROSIS AND FAIRLY WEAK BONES. THE OWL WAS INSERTED UP TO THE BLACK LINE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17931341 ↗
• MalfunctionFeb 8, 2023Migration; Migration

  THIS IS REPORT 2 OF 2 FOR PC-(B)(4). IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN UNKNOWN PROCEDURE ON (B)(6)2023, IT WAS OBSERVED THAT THE 5.5 HEALIX ADVANCE BR 3 SUTURE ANCHOR W/ ORTHOCORD DEVICE CAME OUT OF THE BURR HOLE AFTER DEPLOYMENT. ACCORDING TO THE REPORT, SUBSEQUENTLY A 6.5 HEALIX ADVANCE BR 3 SUTURE ANCHOR W/ ORTHOCORD DEVICE WAS TRIED TO BE DEPLOYED INTO THE SAME BURR HOLE BUT CAME OUT AS WELL. 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 16327281 ↗
• MalfunctionFeb 24, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(4) THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE 6.5 HEALIX ADVANCE BR3SUT W/OC DEVICE BROKE. THERE WAS NO FRAGMENT LEFT IN THE LESION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13593835 ↗
• InjuryJan 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THROUGH CLINICAL RESEARCH FOR CLINICAL EVIDENCE ON SAFETY AND PERFORMANCE THAT POSTOPERATIVELY TO AN INITIAL PROCEDURE OF ROTATOR CUFF REPAIR SURGERY OF THE RIGHT KNEE PERFORMED ON (B)(6) 2018 USING HEALIX ADVANCE BR WITH ORTHOCORD, THE PATIENT HAD A REVISION SURGERY THAT INCLUDED REVERSE TOTAL SHOULDER REPLACEMENT ON (B)(6) 2019 DUE TO PERSISTENT PAIN. ACCORDING TO THE REPORT, THE PATIENT STARTED EXPERIENCING POSTOPERATIVE ABNORMAL OR PROLONGED PAIN, JOINT STIFFNESS, NEUROLOGICAL COMPLICATIONS, AND ARTHROFIBROSIS ON (B)(6) 2018. IT WAS FURTHER REPORTED THAT THE INITIAL PROCEDURES INCLUDED: RTC REPAIR, AND LYSIS OF ADHESIONS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13309949 ↗
• MalfunctionNov 19, 2021Difficult to Advance; Difficult to Advance

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2019, IT WAS OBSERVED THAT THE ANCHOR ON THE 6.5 HEALIX ADVANCE BR3SUT W/OC DEVICE JUST IDLY TURNED AND COULD NOT BE INSERTED FURTHER WHEN THE SURGEON TAPPED AN AWL DURING THE ANCHOR¿S INSERTION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE DEVICE WAS BRAND NEW AND ITS FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12846873 ↗
• MalfunctionDec 29, 2020Delivered as Unsterile Product; Device Contaminated During Manufacture or Shipping; Delivered as Unsterile Product; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ARCR (ARTHROSCOPIC ROTATOR CUFF REPAIR) TREATING ROTATOR CUFF TEAR ON (B)(6) 2020, IT WAS OBSERVED THAT A BLACK SPOT WAS STUCK ON THE WHITE UNSEALED PACKAGE WHICH CONTAINED THE STERILIZED ANCHOR DEVICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE DEVICE WAS THE FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11087597 ↗
• MalfunctionJun 29, 2018Break; Break

  THE SALES REP REPORTED THAT ONE OF THE SUTURES BROKE ON HIS HEALIX ADVANCE BR ANCHOR WHILE TYING THE KNOT IN A SHOULDER PROCEDURE. THE SALES REP REPORTED THAT THE SURGEON WAS USING A KNOT PUSHER AND IT WAS NOT JAGGED. THE SURGEON USED THE OTHER 2 SUTURES TO SECURE THE ANCHOR AND COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES OR DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7652555 ↗