HEALIX ADVANCE BR ANCHOR w/DYNACORD 222000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705029440), received between Oct 21, 2019 and Oct 21, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN ANKLE PROCEDURE ONE OF THE THREADS OF THE HEALIX ADVANCE BR ANCHOR WITH DYNACORD SUTURE BROKE. THE PROCEDURE HAS BEEN SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCES. NO SURGICAL DELAY REPORTED. THIS REPORT IS FOR ONE (1) 4.5MM HEALIX ADVANCE¿ BR ANCHOR WITH DYNACORD¿ SUTURE (BLUE, WHITE/BLUE/GREEN), WITH NEEDLES. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9215481 ↗
• MalfunctionOct 21, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN ANKLE PROCEDURE ONE OF THE THREADS OF THE HEALIX ADVANCE BR ANCHOR WITH DYNACORD SUTURE BROKE. THE PROCEDURE HAS BEEN SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCES. NO SURGICAL DELAY REPORTED. THIS REPORT IS FOR ONE (1) 4.5MM HEALIX ADVANCE¿ BR ANCHOR WITH DYNACORD¿ SUTURE (BLUE, WHITE/BLUE/GREEN), WITH NEEDLES. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9215479 ↗
• MalfunctionOct 21, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN ANKLE PROCEDURE ONE OF THE THREADS OF THE HEALIX ADVANCE BR ANCHOR WITH DYNACORD SUTURE BROKE. THE PROCEDURE HAS BEEN SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCES. NO SURGICAL DELAY REPORTED. THIS REPORT IS FOR ONE (1) 4.5MM HEALIX ADVANCE¿ BR ANCHOR WITH DYNACORD¿ SUTURE (BLUE, WHITE/BLUE/GREEN), WITH NEEDLES. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9215478 ↗