HEALIX ADVANCE ORTHOCORD 222325Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705021536), received between Aug 2, 2018 and Aug 2, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 2, 2018Material Frayed; Material Frayed

  THIS IS REPORT 3 OF 3 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP REPORTED THAT DURING A ROTATOR CUFF REPAIR THAT TWO OF THE CUSTOMER¿S HEALIX ADVANCE PEEK 5.5MM ANCHOR AND ONE OF THEIR HEALIX ADVANCE KNOTLESS PEEK HAD THEIR SUTURE BREAK WHILE IT WAS BEING SHUTTLED. THE SALES REP REPORTED THAT IT WAS THE STAY SUTURE THAT BROKE ON THE KNOTLESS ANCHOR WHEN IT WAS BEING SHUTTLED ALSO. THE SALES REP REPORTED THAT TWO OF THE BREAKS OCCURRED APPROXIMATELY HALF WAY OR IN THE MIDDLE OF THE SUTURE WHILE THE 3RD SUTURE BROKE CLOSER TO THE ANCHOR. THE SURGEON COMPLETED THE PROCEDURE WITH THE DEVICE WITH NO PATIENT CONSEQUENCES BUT WITH A 20 MINUTE DELAY. THE SALES REP REPORTED THAT THERE WERE NO SHARP INSTRUMENTS NEAR THE SUTURES THAT COULD HAVE NICKED OR FRAYED THE SUTURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO 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 7743169 ↗
• MalfunctionAug 2, 2018Material Frayed; Material Frayed

  THIS IS REPORT 1 OF 3 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP REPORTED THAT DURING A ROTATOR CUFF REPAIR THAT TWO OF THE CUSTOMER¿S HEALIX ADVANCE PEEK 5.5MM ANCHOR AND ONE OF THEIR HEALIX ADVANCE KNOTLESS PEEK HAD THEIR SUTURE BREAK WHILE IT WAS BEING SHUTTLED. THE SALES REP REPORTED THAT IT WAS THE STAY SUTURE THAT BROKE ON THE KNOTLESS ANCHOR WHEN IT WAS BEING SHUTTLED ALSO. THE SALES REP REPORTED THAT TWO OF THE BREAKS OCCURRED APPROXIMATELY HALF WAY OR IN THE MIDDLE OF THE SUTURE WHILE THE 3RD SUTURE BROKE CLOSER TO THE ANCHOR. THE SURGEON COMPLETED THE PROCEDURE WITH THE DEVICE WITH NO PATIENT CONSEQUENCES BUT WITH A 20 MINUTE DELAY. THE SALES REP REPORTED THAT THERE WERE NO SHARP INSTRUMENTS NEAR THE SUTURES THAT COULD HAVE NICKED OR FRAYED THE SUTURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO 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 7743166 ↗