DYNACORD 222071Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20886705030047), received between Dec 5, 2022 and Feb 15, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 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.

• MalfunctionFeb 15, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP THAT IN THE MIDDLE OF AN UNSPECIFIED SURGICAL PROCEDURE ON AN UNKNOWN DATE THE DYNACORD MULTIPAK DEVICE SUTURES SNAPPED DURING TENSIONING MID SURGERY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A FIVE MINUTE DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2024. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 3 OF 3 OF THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18712112 ↗
• MalfunctionFeb 15, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP THAT IN THE MIDDLE OF AN UNSPECIFIED SURGICAL PROCEDURE ON AN UNKNOWN DATE THE DYNACORD MULTIPAK DEVICE SUTURES SNAPPED DURING TENSIONING MID SURGERY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A FIVE MINUTE DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2024. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 3 OF THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18712107 ↗
• MalfunctionFeb 8, 2024Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THREE DYNACORD SUTURES SNAPPED WHILE TENSIONING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF FIVE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18672628 ↗
• InjuryDec 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE CLINICAL RESEARCH TEAM THAT POSTOPERATIVELY TO A ROTATOR CUFF REPAIR PROCEDURE OF THE RIGHT SHOULDER PERFORMED ON (B)(6) 2022 USING A 4.5MM HEALIX ADVANCE¿ BR ANCHOR WITH DYNACORD¿ SUTURE DEVICE AND DYNACORD¿ SUTURES, WITH MO-7 NEEDLES DEVICE, THE PATIENT EXPERIENCED RE-TEARS OR NEW TEARS THAT RESULTED IN RE-OPERATION/REVISIONS. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15919413 ↗