HEALIX ADVANCE 222583Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886705030323), received between Dec 26, 2018 and Oct 17, 2023 — classified as 2 injuries, 3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CLINICAL RESEARCH TEAM THAT AFTER ROTATOR CUFF REPAIR ON (B)(6) 2023 THE PATIENT EXPERIENCED ACUTE HYPOXEMIC RESPIRATORY FAILURE. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Respiratory Failure

  MAUDE report 17948721 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 3 OF 3 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THROUGH CLINICAL RESEARCH THAT A PATIENT UNDERWENT A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022 USING A 6.5 HEALIX ADVANCE KNOTLESSS BR DEVICE. ACCORDING TO THE REPORT, THE PATIENT EXPERIENCED SWELLING OF THE LEFT HAND ON (B)(6) 2022, LEFT ELBOW ¿ OLECRANON BURSITIS ON (B)(6) 2022, RE-TEARS/NEW TEARS AND POSSIBLE UNDERLYING INFECTION ON (B)(6) 2022 AND ADHESIVE CAPSULITIS ON (B)(6) 2022. IT WAS REPORTED THAT THESE EVENTS DID NOT RESULT IN A REOPERATION/REVISION SURGERY. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 17400385 ↗
• MalfunctionAug 2, 2021Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT 6.5 HEALIX ADVANCE KNOTLESS BR ANCHOR DEVICE BROKE AT THE NOSE WHEN TRYING TO PASS THE SUTURE THROUGH IT. 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 12258135 ↗
• MalfunctionJul 26, 2021Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT 6.5 HEALIX ADVANCE KNOTLESSS BR ANCHOR DEVICE BROKE AT THE NOSE WHEN TRYING TO PASS THE SUTURE THROUGH IT. 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 12225527 ↗
• MalfunctionDec 26, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE THE SALES REP'S 6.5 HEALIX ADVANCE KNOTLESS BROKE WHILE THREADING THE ANCHOR OUTSIDE OF THE PATIENT. THE SALES REP STATED THAT THE TIP OF ANCHOR BROKE OFF FROM THE REST OF THE IMPLANT. THE SALES REP STATED THAT THE ANCHOR WAS BEING USED WITH DYNACORD AND WITH 2-2.5 SUTURES WITH 4-5 TAILS THAT WERE EQUAL IN LENGTH. THE SALES REP STATED THEY WERE USING A 5.5/6.5 HEALIX ADVANCE AWL FOR THIS PROCEDURE. THE CASE WAS COMPLETED WITH ANOTHER LIKE-ANCHOR IN THE SAME BONE HOLE WITH NO PATIENT HARM, BUT A ONE MINUTE DELAY TO OPEN A NEW ANCHOR. THE DEVICE WAS DISCARDED BY THE CUSTOMER. THE ANCHOR HAD A PIECE BREAK OFF THE DISTAL TIP DURING THREADING. IMPLANTATION WASN¿T ATTEMPTED DUE TO AN INABILITY TO LOAD SUTURE INTO THE ANCHOR, SO BONE QUALITY, CLEATING, ANCHOR AXIS, STAY SUTURE STATUS SHOULD ALL BE INCONSEQUENTIAL. WE COULDN¿T THREAD THE ANCHOR, IT BROKEN AND WAS DISCARDED WITHOUT IT EVER BEING INSIDE OF THE PATIENT. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHO

  Patient problems: Not Applicable

  MAUDE report 8197201 ↗