DYNACORD 222065Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 20886705029997), received between May 6, 2021 and Sep 7, 2022 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Crack” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY SALES REP THAT DURING AN OPEN BICEPS TENODESIS PROCEDURE ON (B)(6)2022, IT WAS OBSERVED THAT THE NEEDLE ON THE DYNACORD¿ SUTURE (BLUE), WITH OS-6 DEVICE WAS POPPING OFF WHILE WHIP STITCHING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15372982 ↗
• MalfunctionSep 7, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A HIP PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE NEEDLE DETACHED FROM THE SUTURE ON THE DYNACORD BLUE W/OS-6 NDL DEVICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12432756 ↗
• MalfunctionMay 6, 2021Crack; Crack

  IT WAS REPORTED BY THE SALES REP IN SWITZERLAND THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT EVERY SECOND SUTURE ON THE DYNACORD¿ SUTURE (BLUE), WITH OS-6 NEEDLE MULTI (12) PACK DEVICE WOULD TEAR FROM THE SUTURE WHILE CLOSING THE SKIN. THE SURGEON STATED THAT HE DID NOT PULL STRONGLY ON THE NEEDLE WHILE SUTURING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787312 ↗
• MalfunctionMay 6, 2021Crack; Crack

  IT WAS REPORTED BY THE SALES REP IN SWITZERLAND THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT EVERY SECOND SUTURE ON THE DYNACORD¿ SUTURE (BLUE), WITH OS-6 NEEDLE MULTI (12) PACK DEVICE WOULD TEAR FROM THE SUTURE WHILE CLOSING THE SKIN. THE SURGEON STATED THAT HE DID NOT PULL STRONGLY ON THE NEEDLE WHILE SUTURING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787308 ↗
• MalfunctionMay 6, 2021Crack; Crack

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN UNKNOWN PROCEDURE ON (B)(6)2021, IT WAS OBSERVED THAT EVERY SECOND SUTURE ON THE DYNACORD" SUTURE (BLUE), WITH OS-6 NEEDLE MULTI (12) PACK DEVICE WOULD TEAR FROM THE SUTURE WHILE CLOSING THE SKIN. THE SURGEON STATED THAT HE DID NOT PULL STRONGLY ON THE NEEDLE WHILE SUTURING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787299 ↗
• MalfunctionMay 6, 2021Crack; Crack

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT EVERY SECOND SUTURE ON THE DYNACORD¿ SUTURE (BLUE), WITH OS-6 NEEDLE MULTI (12) PACK DEVICE WOULD TEAR FROM THE SUTURE WHILE CLOSING THE SKIN. THE SURGEON STATED THAT HE DID NOT PULL STRONGLY ON THE NEEDLE WHILE SUTURING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787298 ↗
• MalfunctionMay 6, 2021Crack; Crack

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT EVERY SECOND SUTURE ON THE DYNACORD¿ SUTURE (BLUE), WITH OS-6 NEEDLE MULTI (12) PACK DEVICE WOULD TEAR FROM THE SUTURE WHILE CLOSING THE SKIN. THE SURGEON STATED THAT HE DID NOT PULL STRONGLY ON THE NEEDLE WHILE SUTURING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787292 ↗
• MalfunctionMay 6, 2021Crack; Crack

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT EVERY SECOND SUTURE ON THE (B)(4) SUTURE (BLUE), WITH OS-6 NEEDLE MULTI (12) PACK DEVICE WOULD TEAR FROM THE SUTURE WHILE CLOSING THE SKIN. THE SURGEON STATED THAT HE DID NOT PULL STRONGLY ON THE NEEDLE WHILE SUTURING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787251 ↗