Monosof SN-664Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521079755), received between Feb 6, 2020 and Jun 28, 2023 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE POPPED OFF A NYLON SUTURE WHILE IN THE DEPTH OF THE WOUND. THE SURGEON HAD TO FISH THE NEEDLE OUT IN THE THIGH. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17216833 ↗
• MalfunctionSep 8, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING SUTURE FOR TRAUMA PROCEDURE, WHEN THE PACKET WAS OPENED FOR USE AND IT WAS HELD BY THE NEEDLE HOLDER, THE THREAD HAS SLIPPED OUT. TOTAL OF FOUR SUTURES HAD THE SAME ISSUE BUT NOT USED ON THE PATIENT. A NEW SUTURE FROM THE SAME BATCH WAS USED WITHOUT AN ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15382709 ↗
• MalfunctionAug 5, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING A KNEE SCOPE PROCEDURE, ON SKIN CLOSURE, THE 12 SUTURE STRANDS BROKE. THE PRODUCT WAS DISCARDED AND ANOTHER WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10371245 ↗
• MalfunctionAug 5, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING A KNEE SCOPE PROCEDURE, ON SKIN CLOSURE, THE 12 SUTURE STRANDS BROKE. THE PRODUCT WAS DISCARDED AND ANOTHER WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10370425 ↗
• MalfunctionMar 4, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE DEVICE'S NEEDLE WAS BROKEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9786668 ↗
• MalfunctionFeb 6, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING BILATERAL BREAST REDUCTION, WHILE BEING APPLIED ON A DRAINAGE STITCH FOR TUBING, THE NEEDLE TIP BROKE OFF AFTER PASSING THROUGH THE TUBING, AND COMING IN CONTACT WITH THE GRASPER. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9676346 ↗

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