Monosof SN-5663Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521078253), received between Aug 26, 2019 and Jul 8, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2024Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, WHEN THE SURGEON ASKED THE INSTRUMENTALIST TO TIE SOME KNOTS IN THE THREAD, THE THREAD BROKE IN THE MIDDLE WHILE TYING A KNOT; IT WAS EASILY CUT. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19693962 ↗
• MalfunctionOct 20, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING THE SKIN, A SMALL PART OF THE NEEDLE BROKE. THE SURGEON WAS AWARE, AND THE SURGICAL TEAM DID A SEARCH OF THE WOUND AND FOUND THE BROKEN PART.

  Patient problems: Insufficient Information

  MAUDE report 17980194 ↗
• MalfunctionApr 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE NEEDLE DETACHED FROM THE THREAD, AND THE NEEDLE WAS TEMPORARILY LOST DURING AN OPEN ORTHOPEDIC PROCEDURE. THE NEEDLE INTO THE PATIENT'S CAVITY AND WAS RETRIEVED WITH A NEEDLE DRIVER. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11617370 ↗
• MalfunctionMar 24, 2020Break; Break

  ACCORDING TO THE REPORTER, WHEN TYING THE KNOT USING INTERRUPTED TECHNIQUE DURING AN OPEN SKIN CLOSURE PROCEDURE, IT WAS STATED THAT THE SUTURE BROKE. A NEW SUTURE WAS THE USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9874498 ↗
• MalfunctionAug 26, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING OPEN LAMINECTOMY EPIDURAL RESECTION <(>&<)> DECOMPRESSION PROCEDURE, THE NEEDLE BROKE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8930412 ↗

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