Coated VICRYL J977HRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10705031043794), received between Apr 14, 2020 and May 4, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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. 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, TIP OF SUTURE BROKE OFF AFTER FIRST CLOSING COUNT (#1 VICRYL CTX REF# J977 LOT #: 10C4M8, WRITER WILL SAVE PACKAGE AND GIVE TO CHARGE). X-RAY OF LEFT KNEE WAS TAKEN AND TIP OF SUTURE WAS LOCATED AND REMOVED BY DR. (B)(6)/DR. (B)(6). A SECOND X-RAY WAS THEN SHOT OF LEFT KNEE (AS PER DR. (B)(6) ORDERS) AND READ BY DR. (B)(6). DR. (B)(6) CALLED INTO OPERATING ROOM AND SPOKE WITH RN AND STATED THERE IS NO RETAINED FOREIGN OBJECT IN PT LEFT KNEE. THEREFORE, FINAL COUNT WAS CORRECT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25073738 ↗
• MalfunctionMar 17, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, NEEDLE CAME OFF SUTURE WHILE CLOSING INCISION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24620962 ↗
• MalfunctionAug 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE IS DETACHING PREMATURELY FROM THE NEEDLE WHILE SUTURING. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19939356 ↗
• MalfunctionAug 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE IS DETACHING PREMATURELY FROM THE NEEDLE WHILE SUTURING. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19939355 ↗
• MalfunctionAug 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE IS DETACHING PREMATURELY FROM THE NEEDLE WHILE SUTURING. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19939345 ↗
• MalfunctionFeb 14, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE OFF IN PATIENT. HEALTHCARE PROVIDER FOUND BROKEN PIECE. THE NEEDLE AND SUTURE WERE SAVED FOR RISK MANAGEMENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18704486 ↗
• MalfunctionJan 31, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE BROKE WHILE THE SURGEON WAS TYING. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16272820 ↗
• MalfunctionOct 3, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE. IT IS UNKNOWN IF IT WAS RETRIEVED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15532393 ↗
• MalfunctionSep 22, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE. IT IS UNKNOWN IF IT WAS RETRIEVED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15463263 ↗
• MalfunctionSep 16, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE LEFT TOTAL KNEE ARTHROPLASTY PROCEDURE, THE TIP OF THE NEEDLE CAME OFF. THEY DID AN X-RAY TO SEE IF THE DEVICE WENT INTO THE PATIENT BUT DID NOT SEE ANYTHING. THE TIP OF THE NEEDLE WAS NEVER RETRIEVED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15442757 ↗
• MalfunctionSep 16, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN LEFT TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE LEFT TOTAL KNEE ARTHROPLASTY PROCEDURE, THE TIP OF THE NEEDLE CAME OFF. THE NEEDLE WAS RETRIEVED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15442684 ↗
• MalfunctionMar 10, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN APPLYING TENSION ON THE SUTURE TO APPROXIMATE THE TISSUE, THE NEEDLE WOULD DISLODGE AT THE SWAGE RIGHT WHERE THE SUTURE ATTACHES TO THE NEEDLE. THIS HAPPENED 4 TIMES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13721834 ↗
• MalfunctionMar 10, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN APPLYING TENSION ON THE SUTURE TO APPROXIMATE THE TISSUE, THE NEEDLE WOULD DISLODGE AT THE SWAGE RIGHT WHERE THE SUTURE ATTACHES TO THE NEEDLE. THIS HAPPENED 4 TIMES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13721829 ↗
• MalfunctionMar 10, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN APPLYING TENSION ON THE SUTURE TO APPROXIMATE THE TISSUE, THE NEEDLE WOULD DISLODGE AT THE SWAGE RIGHT WHERE THE SUTURE ATTACHES TO THE NEEDLE. THIS HAPPENED 4 TIMES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13721819 ↗
• MalfunctionMar 10, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN APPLYING TENSION ON THE SUTURE TO APPROXIMATE THE TISSUE, THE NEEDLE WOULD DISLODGE AT THE SWAGE RIGHT WHERE THE SUTURE ATTACHES TO THE NEEDLE. THIS HAPPENED 4 TIMES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13721812 ↗
• MalfunctionNov 10, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF THE SUTURE OR SUTURE BREAKING OFF NEEDLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12788337 ↗
• MalfunctionNov 10, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF THE SUTURE OR SUTURE BREAKING OFF NEEDLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12788326 ↗
• MalfunctionApr 14, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION DELIVERY IN (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE TIP OF THE NEEDLE WAS NOTICED TO BE BROKEN AFTER PICKED UP TO PUT IN NEEDLE BOARD. THE SURGEON WAS INFORMED. THE SURGEON CHECKED THE ABDOMEN, IRRIGATED, COMPLETED THOROUGH SEARCH OF WOUND INCLUDING RAN THROUGH SUTURE HOLES. DRAPES WERE ALSO CHECKED, UNABLE TO LOCATE TIP. DUE TO THE SIZE OF THE TIP, PROVIDER REFUSED XRAY. IT IS UNKNOWN HOW THE CASE WAS COMPLETED, HOWEVER, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 9958114 ↗