HEALIX ADVANCE 222335Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705023431), received between Jan 28, 2019 and Jul 26, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 26, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ARTHROSCOPIC SHOULDER ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE 6.5MM HEALIX ADVANCE KNOTLESS PEEK ANCHOR DEVICE BROKE WHEN PULLING TAPES THROUGH. 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 17402191 ↗
• InjuryMar 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THROUGH A REVIEW OF A CLINICAL RESEARCH REPORT FOR CLINICAL EVIDENCE ON SAFETY AND PERFORMANCE OF 6.5 HEALIX ADVANCE KNTLSS PK DEVICE THAT POSTOPERATIVELY TO A ROTATOR CUFF REPAIR PROCEDURE PERFORMED ON AN UNKNOWN DATE IN 2017, A PATIENT HAD A REOPERATION 28 DAYS AFTER THE INITIAL PROCEDURE DUE TO INFECTION THAT INCLUDED IRRIGATION AND DEBRIDEMENT. ACCORDING TO THE REPORT, THE PATIENT HAD AN INFECTION, EDEMA AND PAIN POSTOPERATIVELY TO THE INITIAL PROCEDURE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 13969199 ↗
• MalfunctionJan 28, 2019Crack; Crack

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A ROTATOR CUFF REPAIR/GREATER TUBEROSITY REPAIR SURGICAL PROCEDURE, THE SURGEON IMPLANTED SIMILAR ANCHOR LOADED WITH MITEK PERMATAPE. THE SURGEON THEN IMPLANTED ABOVE ANCHOR, AS A LATERAL ROW ANCHOR, AND ATTEMPTED TO LOAD THE PERMATAPE (ATTACHED TO PREVIOUS (MEDIAL ROW ANCHOR), INTO THIS ANCHOR - 2 X STRANDS OF TAPE (DOUBLED OVER = 4 STRANDS, AS WHEN IT IS LOADED IN THE WIRE KITE, BEING PULLED THROUGH CENTRAL BORE OF ANCHOR) PLUS THE 2 X STRANDS OF NO.2 ORTHOCORD (ALREADY PRE-LOADED IN ANCHOR) THIS COMBINED VOLUME OF TAPE WAS TOO THICK FOR CENTRAL BORE OF 6.5MM HEALIX KNOTLESS ANCHOR. IT WAS REPORTED THAT THE TAPE/CORD GOT STUCK BUT WHEN SURGEON PULLED HARDER, IT WAS OBSERVED THAT THE WIRE BROKE. THE SURGEON USED RED TAB/WIRE KITE, FROM PREVIOUS ANCHOR, TO FIRST LOAD PERMATAPE, THEN THE ORTHOCORD. THE SURGEON VOICED DISPLEASURE THAT HE HAD TO DO THIS, SAID THAT THE HEALIX ANCHOR SHOULD BE ABLE TO ACCEPT TAPE, AS WELL AS THE RESIDENT ORTHOCORD. THERE WAS A 10 MINUTE DELAY TO PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8281639 ↗