Monosof SN-669Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521079861), received between May 7, 2020 and May 1, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (6 reports).

2 other recalls cover devices cleared under the same FDA submission (K900531); they may or may not involve this specific model.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2026Break

  IT WAS REPORTED THAT DURING UMBILICAL CATHETERIZATION, THE THREAD BROKE WHEN TIGHTENING THE KNOT DURING THE PROCEDURE. NO EXTRA FORCE WAS USED WHEN TYING. IT WAS FURTHER REPORTED THAT THIS ISSUE OCCURRED ON A TOTAL OF THREE DEVICES. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THE PATIENT WAS REPORTED ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25061913 ↗
• MalfunctionMay 1, 2026Break

  IT WAS REPORTED THAT DURING UMBILICAL CATHETERIZATION, THE THREAD BROKE WHEN TIGHTENING THE KNOT DURING THE PROCEDURE. NO EXTRA FORCE WAS USED WHEN TYING. IT WAS FURTHER REPORTED THAT THIS ISSUE OCCURRED ON A TOTAL OF THREE DEVICES. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THE PATIENT WAS REPORTED ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25061907 ↗
• MalfunctionMay 1, 2026Break

  IT WAS REPORTED THAT DURING UMBILICAL CATHETERIZATION, THE THREAD BROKE WHEN TIGHTENING THE KNOT DURING THE PROCEDURE. NO EXTRA FORCE WAS USED WHEN TYING. IT WAS FURTHER REPORTED THAT THIS ISSUE OCCURRED ON A TOTAL OF THREE DEVICES. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THE PATIENT WAS REPORTED ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25061850 ↗
• MalfunctionJul 3, 2023Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN LAPAROTOMY, WHILE CLOSING THE SKIN, TWO SUTURE THREADS BROKE EASILY AND THE SURGEON WAS UNABLE TO PUT ANY FORCE ON IT. IN ADDITION, THE THREADS WERE NOT BLACK, THESE ARE MORE LIKE UNDYED OR BROWN. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THE SURGERY WAS EXTENDED FOR LESS THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17250055 ↗
• MalfunctionMar 8, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, DURING CLOSURE, THE SUTURE BROKE MULTIPLE TIMES DURING THE CASE. THE SURGEON USED A NEW SUTURE AND WAS ABLE TO FINISH THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13691406 ↗
• MalfunctionJul 16, 2021Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN LAPAROTOMY, WHILE CLOSING THE SKIN, THE DEVICE THREAD BROKE EASILY AND THE SURGEON WAS UNABLE TO PUT ANY FORCE ON IT. IN ADDITION THE THREAD IS NOT BLACK, IT IS MORE LIKE UNDYED OR BROWN. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THE SURGERY WAS EXTENDED FOR LESS THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12182090 ↗
• MalfunctionMay 7, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY PROCEDURE, THE PACKET WAS OPENED AND THE NEEDLE DETACHED FROM THE THREAD. ANOTHER SUTURE WAS USED TO COMPLETE THE PROCEDURE. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE DEVICE WAS NOT USED ON THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10032608 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K900531. One submission often covers many models, so check the product and lot details in each record.

• Z-1173-2023 · Dec 2, 2022 · Open, Classified
  Monofilament Nylon Suture (McKesson Branded) and Coated Braided Silk Suture (McKesson Branded) (1) S661GX 5-0 NYLON 18 DS18 (2)S683GX 4-0 SILK 18 DS18 (3) S683GX
• Z-1174-2023 · Dec 2, 2022 · Open, Classified
  Monosof Monofilament Nylon sutures: Product Description CN-724 MONOSOF* 1 BLK 100CM GS25 X36 CN-791 MONOSOF* 2-0 BLK 100CM GCC90X36 CN-791-12 MONOSOF* 2-0 BLK 10