Monosof SN-764Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521080188), received between Feb 5, 2018 and Jan 5, 2022 — classified as 1 injury, 3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 5, 2022Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER DURING A TETHERED CORD RELEASE ON AN OPEN PROCEDURE, THE DEVICE BROKE AND THE SURGEON EXTENDED THE OR TIME OF 45 MINUTES OR MORE DUE TO SEVERAL NEEDLES BROKEN. ONLY 2 OUT OF 30 SUTURE NEEDLES WORKED. TO RESOLVE THE ISSUE MORE SUTURES ARE USED. THE PATIENT IS CURRENTLY STILL IN HOSPITAL.

  Patient problems: Impaired Healing

  MAUDE report 13168385 ↗
• MalfunctionOct 17, 2019Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE THREAD BROKE. THE SUTURE WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9203256 ↗
• MalfunctionMay 17, 2018Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING A SKIN CLOSURE PROCEDURE, WHEN CLOSING THE TISSUE, THE PHYSICIAN WAS PULLING CLOSE THE SUTURE THROUGH THE WOUND, THE NEEDLE BROKE IN HALF AND FELL INTO THE PATIENT CAVITY. BOTH PIECES OF THE NEEDLE WERE RETRIEVED IMMEDIATELY. THEY GOT ANOTHER SUTURE FROM THE SAME PACKAGE TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7522648 ↗
• MalfunctionFeb 5, 2018Break; Break

  ACCORDING TO THE REPORTER, WHEN UTILIZING THE MATTRESS SUTURING TECHNIQUE WHILE CLOSING AN OPEN RADICAL RESECTION OF BACK MELANOMA, THE NEEDLE BROKE WHEN PASSING THROUGH A THICK TISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7242234 ↗

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-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
• 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