Coated VICRYL J519HRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10705031040892), received between May 13, 2019 and May 2, 2023 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Break” (11 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMay 2, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. THE NEEDLE GOT BROKEN DURING THE CLOSURE OF THE APONEUROSIS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Abscess; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16853108 ↗
• MalfunctionSep 29, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12550193 ↗
• MalfunctionSep 29, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12550191 ↗
• MalfunctionSep 29, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12550188 ↗
• MalfunctionSep 29, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12550187 ↗
• MalfunctionSep 29, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12550186 ↗
• MalfunctionSep 29, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12550184 ↗
• MalfunctionAug 9, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12297330 ↗
• MalfunctionAug 9, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12297314 ↗
• MalfunctionAug 9, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12297304 ↗
• MalfunctionAug 9, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12297286 ↗
• MalfunctionJul 9, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2021 AND THE SUTURE WAS USED FOR KNEE CAPSULE CLOSURE. DURING SURGERY, THE SUTURE BROKE. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12147663 ↗
• MalfunctionJul 9, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2021 AND THE SUTURE WAS USED FOR KNEE CAPSULE CLOSURE. DURING SURGERY, THE SUTURE BROKE. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12147658 ↗
• MalfunctionJul 9, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON 6/15/2021 AND THE SUTURE WAS USED FOR KNEE CAPSULE CLOSURE. DURING SURGERY, THE SUTURE BROKE. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12147655 ↗
• MalfunctionJul 9, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2021 AND THE SUTURE WAS USED FOR KNEE CAPSULE CLOSURE. DURING SURGERY, THE SUTURE BROKE. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12147651 ↗
• MalfunctionJul 9, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2021 AND THE SUTURE WAS USED FOR KNEE CAPSULE CLOSURE. DURING SURGERY, THE SUTURE BROKE. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12147642 ↗
• MalfunctionJul 17, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT SURGERY IN 2019 AND THE SUTURE WAS USED. DURING CLOSING THE JOINT KNEE CAPSULE, THE SUTURE BROKE. THE PROCEDURE WAS NOT DELAYED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WILL BE REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8801135 ↗
• MalfunctionMay 13, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE CAME OFF THE END OF THE SUTURE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8605053 ↗