HEALIX ADVANCE DYNATAPE DYNACORD 280724Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705031054), received between Nov 7, 2022 and Nov 7, 2022 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2022Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT A PATIENT HAD A ROTATOR CUFF REPAIR REVISION PROCEDURE ON (B)(6) 2022 AS THE ROTATOR CUFF DID NOT HEAL. ACCORDING TO THE REPORT, THERE WERE TWO MEDIAL ROW ANCHORS IN CUFF. IT WAS REPORTED THAT THE ANCHORS REMAINED IN BONE AND SUTURE REMAINED IN TISSUE WHILE THE KNOT REMAINED INTACT AND SUTURE KNOT LOOP WAS LOOSE OUTSIDE OF ANCHOR BODY ON BOTH MEDIAL ROW ANCHORS. IT WAS REPORTED THAT THE THOUGHT WAS THAT THE EYELIT SUTURE ARM BAR BROKE AND SUTURES WITH KNOTS INTACT BECAME LOOSE OUTSIDE OF ANCHOR BODY. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15745417 ↗