Monosof SN-5699Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10884521079175), received between Apr 19, 2017 and Mar 25, 2026 — classified as 4 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (10 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHILE REMOVING THE NEEDLE AND SUTURE FROM THE RETAINER, THE SUTURE DETACHED FROM THE NEEDLE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24689014 ↗
• MalfunctionJan 24, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, PRIOR TO PATIENT USE, WHEN WITHDRAWING THE SUTURE FROM THE RETAINER AND PREPARING FOR SUTURING, THE NEEDLE DETACHED. THE SAME ISSUE OCCURRED ON THE SECOND SUTURE FROM THE SAME BATCH. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24173442 ↗
• MalfunctionJan 24, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, PRIOR TO PATIENT USE, WHEN WITHDRAWING THE SUTURE FROM THE RETAINER AND PREPARING FOR SUTURING, THE NEEDLE DETACHED. THE SAME ISSUE OCCURRED ON THE SECOND SUTURE FROM THE SAME BATCH. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24173441 ↗
• MalfunctionMay 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, PRIOR TO PATIENT USED, WHEN TRIED TO USE THE SUTURE BY CLAMPING IT WITH THE DEVICE, THE NEEDLE AND SUTURE GOT DETACHED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19323871 ↗
• MalfunctionFeb 28, 2024Break; Break

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE PATIENT CAME IN WITH BLEEDING FROM TEMPORAL ARTERY FROM FACIAL LACERATION, WHEN THE SURGEON ATTEMPTED TO GET HEMOSTATIC CONTROL WITH FIGURE EIGHT STITCH, WHEN THE NEEDLE WAS PLACED, THE NEEDLE SNAPPED OFF IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 18798186 ↗
• MalfunctionAug 21, 2023Material Frayed; Detachment of Device or Device Component; Material Frayed; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE SUTURE WAS FRAYING WHEN PULLED THROUGH THE SKIN AND THE NEEDLE WAS BREAKING OFF OF THE SUTURE.

  Patient problems: Insufficient Information

  MAUDE report 17592369 ↗
• MalfunctionApr 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE EXCISION OF NEVUS BASAL CELL CARCINOMA, THE THREAD DETACHED FROM THE NEEDLE ON THREE SUTURES. NO COMPONENT FELL INTO THE PATIENT'S CAVITY. CONTINUED WITH THE PIECE THAT WAS THERE AND KNOTTED IT TO COMPLETE THE CASE. THREAD CAME OFF DIRECTLY FROM NEEDLE, NEW THREAD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16746346 ↗
• MalfunctionFeb 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING DISTAL RADIUS FRACTURE REPAIR SURGERY, WHILE ON WOUND CLOSURE/SURGICAL INCISION CLOSURE. THE NEEDLE WAS PASSED THROUGH THE TISSUE AND WHEN THE NEEDLE WAS PULLED OUT IT CAME OFF AND THE THREAD WAS LOST SOMEWHERE. A NEW SUTURE FROM THE SAME LOT WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16401774 ↗
• MalfunctionSep 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A KNEE JOINT SURGERY, ON FOUR DEVICES, UPON OPENING, THE NEEDLE SEPARATED TO THE THREAD AS A WHOLE. THE DEVICES WERE NOT USED ON THE PATIENT. TO RESOLVE THE ISSUE, A DEVICE FROM A DIFFERENT LOT NUMBER WERE USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15371598 ↗
• InjuryOct 2, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHILE SUTURING THE WOUND FROM SECOND LESION EXCISED A NEEDLE TIP BROKE OFF WHILE THE NEEDLE FROM THE WOUND. THE NEEDLE TIP COULD NOT BE LOCATED, WOULD BE 1-2MM FRAGMENT. THE WOUND WAS SEARCHED THOROUGHLY AND AS IT BROKE WHILE REMOVING THE NEEDLE AND WAS UNLIKELY THAT THE NEEDLE TIP REMAINED IN THE WOUND. THE PATIENT WAS CAUTIONED ON POTENTIAL FOR RETAINED NEEDLED FRAGMENT AND WAS ENCOURAGED TO TELL IF MORE PAIN WAS FELT THAN EXPECTED. IT WAS STATED THAT THE WOUND WILL BE EXAMINED AFTER A WEEK FOR SUTURE REMOVAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 10618590 ↗
• MalfunctionJan 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING SUTURING ON A SUB TOTAL GASTRECTOMY, WHEN OPENING THE PACKAGE, THE NEEDLE WAS FOUND DISENGAGED FROM THE THREAD FROM THE BEGINNING, AND THE SUTURE WAS NOT USED ON THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 8279335 ↗
• InjuryApr 20, 2017Break; Break

  ACCORDING TO THE REPORTER: DURING CARPEL TUNNEL REPAIR (OPEN) PROCEDURE, THE NEEDLE BROKE. THE SURGEON STATED THAT PATIENT WAS SHOWING ABSCESS POST -OPERATIVELY. HE ALSO STATED THAT THE NEEDLE DID NOT SEEM DURABLE, SHARP, AND SUTURE SITE (CLOSING OF SKIN) WAS INFECTED. MEDICAL OR SURGICAL INTERVENTION WAS NEEDED, SOAK OR ANTIBIOTIC TREATMENT WAS PRESCRIBED PATIENT STATUS: ALIVE WITH INJURY.

  Patient problems: Post Operative Wound Infection

  MAUDE report 6506935 ↗
• InjuryApr 19, 2017Break; Break

  ACCORDING TO THE REPORTER: DURING CARPEL TUNNEL REPAIR (OPEN) PROCEDURE WHILE EMPLOYING CLOSING SKIN, THE NEEDLE AND THREAD BROKE. THE SURGEON STATED THAT THE NEEDLE DID NOT SEEM DURABLE, SHARP, AND SUTURE SITE (CLOSING OF SKIN) WAS INFECTED. MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO TREAT SURGICAL SITE INFECTION. PATIENT STATUS: ALIVE WITH INJURY

  Patient problems: Post Operative Wound Infection

  MAUDE report 6504292 ↗
• InjuryApr 19, 2017Break; Break

  ACCORDING TO THE REPORTER: DURING CARPEL TUNNEL REPAIR (OPEN) PROCEDURE WHILE EMPLOYING SKIN /WOULD CLOSURE, THE NEEDLE AND THREAD BROKE . THE SURGEON STATED THAT THE NEEDLE DID NOT SEEM DURABLE, ROBUST, AND SUTURE SITE (CLOSING OF SKIN) WAS INFECTED. MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO TREAT THE SUTURE SITE INFECTION. PATIENT STATUS: ALIVE WITH INJURY.

  Patient problems: Post Operative Wound Infection

  MAUDE report 6503911 ↗

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