Monosof SN-5698GRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521079151), received between Aug 4, 2017 and May 12, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE SUTURING OF LEFT RING FINGER, AFTER THE SURGEON WAS ABLE TO PLACE THE 1ST SUTURE AND TIED OFF, AND WHILE THE SURGEON WAS PLACING THE 2ND SUTURE, THE CURVED TIP OF THE NEEDLE BROKE OFF IN PATIENT LACERATION. THE OTHER HALF WAS ATTACHED TO THE SUTURE THREAD. THIS IRRIGATED AND EXPLORED A BLOODLESS FIELD, THAT WAS UNABLE TO RETRIEVE. THE PATIENT HAD TO GO TO EMERGENCY ROOM FOR X-RAY AND REMOVAL.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 14381749 ↗
• MalfunctionJan 3, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING WOUND CLOSURE AFTER DENTAL TOOTH EXTRACTION, WHEN THE REPORTED SUTURE WAS USED TO KNOT THE THREAD, ALL OF THE THREAD BROKE. THE SURGEON OPENED A NEW BOX OF SUTURE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13142782 ↗
• MalfunctionAug 4, 2017Break; Break

  ACCORDING TO THE REPORTER, THE SUTURES BROKE TWICE DURING THE PROCEDURE. NO PATIENT INJURY NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6769519 ↗

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