HEALIX ADVANCE ORTHOCORD 222323Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886705021512), received between Aug 17, 2018 and Sep 12, 2025 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2025Crack; Crack

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE WHEN THE 5.5 HEALIXADV BR 5PK-2SUTURE DEVICE WAS OPENED, AND THE SURGEON WAS READY TO INSERT THE DEVICE, IT WAS OBSERVED THAT THE ANCHOR BODY WAS CRACKED AT THE BASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23043358 ↗
• MalfunctionJul 11, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED BY THE SALES REP IN GERMANY THAT THE 5.5MM HEALIX ADVANCE BR MULTIPACK - 2 SUTURE DEVICE HAD POLLUTION IN THE PACKAGING. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17300122 ↗
• MalfunctionAug 23, 2018Material Frayed; Material Frayed

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR, IT WAS OBSERVED THAT THE BLUE SUTURE ON THE CUSTOMER'S HEALIX ADVANCE 5.5MM BR ANCHOR WITH TWO SUTURES BROKE NEAR THE END OF THE STRAND WHEN THE SURGEON HAD JUST STARTED TO LIGHTLY TENSION THE KNOT. THE SURGEON COMPLETED THE PROCEDURE BY SECURING THE ANCHOR WITH THE REMAINING PART OF THE BLUE SUTURE TO THE VIOLET SUTURE WITH NO PATIENT CONSEQUENCES OR DELAYS. 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 7810286 ↗
• MalfunctionAug 17, 2018Material Frayed; Material Frayed

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR, IT WAS OBSERVED THAT THE BLUE SUTURE ON THE CUSTOMER'S HEALIX ADVANCE 5.5MM BR ANCHOR WITH TWO SUTURE BROKE NEAR THE END OF THE STRAND WHEN THE SURGEON HAD JUST STARTED TO LIGHTLY TENSION THE KNOT. THE SURGEON COMPLETED THE PROCEDURE BY SECURING THE ANCHOR WITH THE REMAINING PART OF THE BLUE SUTURE TO THE VIOLET SUTURE WITH NO PATIENT CONSEQUENCES OR DELAYS. 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 7794819 ↗