Monosof SN-5669Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521078864), received between Mar 16, 2018 and Nov 11, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2025Break; Break

  IT WAS REPORTED THAT DURING USE, THE SUTURE BROKE WHILE SUTURING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23525246 ↗
• MalfunctionDec 15, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING OPEN MASTECTOMY, THE TIP OF THE NEEDLE BROKE OFF WHILE THE SURGEON WAS PULLING THE NEEDLE OUT OF THE SKIN. THE SURGEON WAS ABLE TO COMPLETE THE STITCH AFTER SEARCHING AND LOCATING THE BROKEN NEEDLE TIP WHICH WAS FOUND ON THE FLOOR. THIS RESULTED TO 30 MINUTES EXTENDED SURGICAL TIME, BUT THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13009732 ↗
• MalfunctionDec 29, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING RE WASHOUT AND CLOSURE OF RIGHT LEG WOUND PROCEDURE, THE THREAD DETACHED FROM THE NEEDLE AFTER 1/3 HAD BEEN USED WHILE CLOSING A 15CM WOUND. ANOTHER SUTURE WAS OPENED AND USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11087954 ↗
• MalfunctionApr 3, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING AN OPEN REDUCTION AND INTERNAL FIXATION OF THE ANKLE, WHEN THE TECH HANDED THE SUTURE TO THE SURGEON. AS THEY MOVED TOWARD THE PATIENT TO BEGIN USING THE SUTURE, THE THREAD SEPARATED FROM THE NEEDLE. THEY THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8478504 ↗
• MalfunctionMar 16, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE NEEDLE DETACHED, SAME THING OCCURRED TWO TO THREE TIMES IN ONE CASE. THEY USED ANOTHER DEVICE IN ORDER TO COMPLETE THE CASE. THE PATIENT STATUS WAS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7346585 ↗
• MalfunctionMar 16, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE NEEDLE DETACHED, SAME THING OCCURRED TWO TO THREE TIMES IN ONE CASE. THEY USED ANOTHER DEVICE IN ORDER TO COMPLETE THE CASE. THE PATIENT STATUS WAS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7345333 ↗

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