HEALIX ADVANCE ORTHOCORD 222311Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705021451), received between Oct 21, 2021 and Nov 5, 2025 — classified as 1 injury, 1 malfunction.

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

• MalfunctionNov 5, 2025Break; Break

  IT WAS REPORTED THAT THE SURGEON USED THE PUNCH FIRST FOR THIS 6.5 HEALIX ADVANCE PEEK 3SUT W/OC DEVICE ANCHOR. IT WAS REPORTED THAT IT WAS A LITTLE BIT HARDER THAN EXPECTED AND THE DISTAL TIP BROKE OFF. 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 23477077 ↗
• InjuryOct 21, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE HEX HEAD OF THE INSERTER ON THE 6.5 HEALIX ADVANCE PEEK 3 SUTURE ANCHOR W/ ORTHOCORD DEVICE BROKE OFF IN THE PATIENT. ACCORDING TO THE REPORT, THE FRAGMENT COULD NOT BE FOUND AND IT WAS NOT RETRIEVED. IT WAS FURTHER REPORTED THAT X-RAYS CONFIRMED THE PRESENCE OF THE CANNULATED PORTION OF THE DEVICE IN THE PATIENT´S BODY. THE STATUS OF THE PATIENT POST-SURGERY WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12675300 ↗