Maxon SMM-5323Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884523004687), received between Nov 8, 2017 and Apr 3, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K990951); 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2026Break

  ACCORDING TO THE REPORTER, THE TWO NEEDLES BROKE.

  Patient problems: Insufficient Information

  MAUDE report 24775561 ↗
• MalfunctionApr 1, 2026Break

  ACCORDING TO THE REPORTER, THE TWO NEEDLES BROKE.

  Patient problems: Insufficient Information

  MAUDE report 24759212 ↗
• MalfunctionNov 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE DETACHED FROM THE THREAD.

  Patient problems: Insufficient Information

  MAUDE report 12805536 ↗
• MalfunctionSep 24, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN INGUINAL HERNIA PROCEDURE, THE DEVICE NEEDLE BROKE FROM THE THREAD. THE SURGEON 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 10579162 ↗
• MalfunctionSep 23, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A BREAST CONSTRUCTION PROCEDURE, WHILE UNPACKING THE SUTURE, THE NEEDLE WAS DETACHED. ANOTHER SUTURE WITH THE SAME LOT NUMBER WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10573881 ↗
• MalfunctionSep 12, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BARIATRIC SURGERY, THE NEEDLE BROKE OFF FROM THE THREAD. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9014678 ↗
• MalfunctionAug 23, 2019Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE THREAD BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8925515 ↗
• MalfunctionFeb 19, 2019Break; Break

  ACCORDING TO THE REPORTER, WHILE CLOSING TRAVERSE ON AN OPEN CORONARY ARTERY BYPASS GRAFTING, THE THREAD BROKE. ANOTHER DEVICE WAS OPENED AND USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8350299 ↗
• MalfunctionNov 8, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, BOTH THE NEEDLE AND THE THREAD BROKE. NO PART OF THE DEVICE FELL INTO THE PATIENT CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7008998 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K990951. One submission often covers many models, so check the product and lot details in each record.

• Z-2542-2017 · May 3, 2017 · Terminated
  Sutures. MAXON: MAXON 4/0 5X18" GREEN CV-24 D-TACH; Item Number: 8886621933; MAXON 5/0 5X18 GR CV-23 D-TACH; Item Number: XX2109; MAXON* 4/0 5X30 GREEN V-20 D*TACH; Item Number: