McKesson S699GXRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10612479214528), received between Jan 12, 2018 and Jun 25, 2024 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE LACERATION REPAIR, THE TWO SUTURE AND NEEDLE GOT SEPARATED MAKING THE PRODUCT UNUSABLE. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19606739 ↗
• MalfunctionJun 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE LACERATION REPAIR, THE TWO SUTURE AND NEEDLE GOT SEPARATED MAKING THE PRODUCT UNUSABLE. ONE OF THE SUTURE, THE PROVIDER WAS GOING THROUGH THE SKIN AND IT CAME OFF AND THE OTHER SUTURE WAS WHEN THE SURGEON WAS TYING THE KNOT AND IT POPPED OFF. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19606513 ↗
• MalfunctionJan 4, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE SNAPPED OFF AT THE END AND BROKE.

  Patient problems: Insufficient Information

  MAUDE report 16098675 ↗
• MalfunctionJan 4, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE SNAPPED OFF AT THE END AND BROKE.

  Patient problems: Insufficient Information

  MAUDE report 16098607 ↗
• MalfunctionDec 19, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING THE FINGER, THE NEEDLE BROKE OFF IN THE PATIENT'S FINGER USING A 4.0 SUTURE TO CLOSE THE WOUND. THE SURGEON HAD TO DIG OUT THE BROKEN NEEDLE AND OPEN ANOTHER NEW SUTURE, AND WHILE SEWING, THE SECOND NEEDLE BROKE OFF. AGAIN, THE SURGEON HAD TO DIG THE BROKEN NEEDLE OUT OF THE PATIENT'S FINGER. USED ANOTHER SUTURE FROM ANOTHER BOX TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16010196 ↗
• MalfunctionJun 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING RIGHT INDEX FINGER LACERATION REPAIR, THE NEEDLE WAS SECURED USING NEEDLE DRIVER AND INTRODUCED TO WOUND EDGE. NEEDLE DRIVER WAS ABLE TO LOOP THE NEEDLE THROUGH WOUND UP TO THE OPPOSITE SIDE, HOWEVER THE BASE OF THE NEEDLE BROKE APPROXIMATELY 2MM FROM NYLON SUTURE. ANOTHER SUTURE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11966091 ↗
• MalfunctionOct 8, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE DEVICE'S NEEDLE COMING APART FROM THE SUTURE STRING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10652341 ↗
• MalfunctionSep 24, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE THREAD OF THE DEVICE BROKE. OPENED ANOTHER SUTURE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9113917 ↗
• InjuryFeb 27, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING EXCISION OF SKIN LESION ON THE PATIENT'S FOREHEAD, THERE WERE 2 REPEATED SUTURE BREAKAGES. ON THE SECOND OCCURRENCE, THE NEEDLE COULD NO LONGER BE LOCATED. THE PATIENT WAS SENT FOR AN X-RAY WITH A MARKER PLACED IN ORDER TO LOCATE THE NEEDLE. PATIENT WAS THEN RETURNED TO THE PROCEDURE ROOM FOR THE REMOVAL OF THE NEEDLE. THERE WAS SERIOUS PATIENT INJURY.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 7299636 ↗
• MalfunctionJan 12, 2018Break; Material Separation

  DURING SURGICAL PROCEDURE PERFORMED TO EXCISE A SKIN LESION FROM PATIENT'S FOREHEAD, THERE WERE REPEATED SUTURE BREAKAGES. THERE WERE TWO OCCURRENCES OF COMPLETE SEPARATIONS OF NEEDLES FROM SUTURES. DURING THE SECOND OCCURRENCE, THE NEEDLE COULD NOT BE LOCATED. THE PATIENT WAS SENT TO X-RAY WITH A MARKER PLACED IN ORDER TO LOCATE THE NEEDLE. PATIENT WAS RETURNED TO THE PROCEDURE ROOM WHERE THE NEEDLE WAS LOCATED AND REMOVED WITHOUT FURTHER INCIDENCE.

  Patient problems: No Code Available

  MAUDE report 7185470 ↗

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