Maxon SMM-5033Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10884523004601), received between Jun 29, 2018 and Dec 18, 2025 — classified as 1 injury, 32 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (27 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING WOUND CLOSURE, WHEN THE SCRUB NURSE GRASPED AND REMOVED THE NEEDLE FROM THE RETAINER, THE NEEDLE ATTACHMENT POINT AND THE THREAD BECAME DETACHED. THE PRODUCT WAS NOT USED ON A PATIENT. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23836180 ↗
• MalfunctionJul 11, 2025Break; Difficult to Open or Remove Packaging Material; Break; Difficult to Open or Remove Packaging Material

  ACCORDING TO THE REPORTER, DURING AN OBSTETRIC AND GYNECOLOGICAL PROCEDURE, DURING SUTURING OF THE DERMAL, WHEN THE FIRST SUTURE WAS BEING REMOVED FROM THE PACKAGING, THE CATCH WAS FELT AT THE THREAD, AND WHEN IT WAS TRIED TO BE TAKEN OUT, IT GOT BROKEN, AND THE THREAD WOULD NOT COME OUT EVEN WHEN PULLED. WHEN THE SECOND SUTURE WAS TAKEN OUT OF THE PACKAGING AND AN ATTEMPT WAS MADE TO STRAIGHTEN THE THREAD IN THE SURGICAL FIELD, THE THREAD DETACHED FROM THE SWAGE. WHEN USING THE THIRD SUTURE, WHEN TRYING TO REMOVE IT, IT WAS HARD, AND THE SUTURE GOT BROKEN. A FOURTH SUTURE WAS OPENED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22480553 ↗
• MalfunctionJul 11, 2025Break; Difficult to Open or Remove Packaging Material; Break; Difficult to Open or Remove Packaging Material

  ACCORDING TO THE REPORTER, DURING AN OBSTETRIC AND GYNECOLOGICAL PROCEDURE, DURING SUTURING OF THE DERMAL, WHEN THE FIRST SUTURE WAS BEING REMOVED FROM THE PACKAGING, THE CATCH WAS FELT AT THE THREAD, AND WHEN IT WAS TRIED TO BE TAKEN OUT, IT GOT BROKEN, AND THE THREAD WOULD NOT COME OUT EVEN WHEN PULLED. WHEN THE SECOND SUTURE WAS TAKEN OUT OF THE PACKAGING AND AN ATTEMPT WAS MADE TO STRAIGHTEN THE THREAD IN THE SURGICAL FIELD, THE THREAD DETACHED FROM THE SWAGE. WHEN USING THE THIRD SUTURE, WHEN TRYING TO REMOVE IT, IT WAS HARD, AND THE SUTURE GOT BROKEN. A FOURTH SUTURE WAS OPENED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22480537 ↗
• MalfunctionJul 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN THE FIRST SUTURE WAS BEING REMOVED FROM THE PACKAGING, THE THREAD WOULD NOT COME OUT EVEN WHEN PULLED. THE SAME ISSUE OCCURRED ON THE SECOND SUTURE. WHEN THE THIRD SUTURE WAS TRYING TO STRAIGHTEN THE THREAD, THE THREAD CAME OUT OF THE NEEDLE. A FOURTH SUTURE WAS OPENED AND USED TO RESOLVE THE ISSUE.

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

  MAUDE report 22468655 ↗
• MalfunctionNov 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHEN THE PACKET WAS OPENED, THE NEEDLE AND THREAD WERE FOUND TO BE SEPARATED. ANOTHER SUTURE WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20743657 ↗
• MalfunctionOct 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A ROBOT ASSISTED LAPAROSCOPIC STOMACH RESECTION PROCEDURE, WHILE PREPARING AND BEFORE USING FOR WOUND CLOSURE AND DERMAL SUTURE, AFTER THE USER OPENED THE ALUMINUM PACKAGE, WHILE WITHDRAWING THE DEVICE FROM THE RETAINER, THE NEEDLE AND THREAD WERE NOT ATTACHED, THUS IT COULD NOT BE USED. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20391502 ↗
• MalfunctionJan 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING COLECTOMY PROCEDURE, WHEN THE CIRCULATING NURSE HANDED THE PRODUCT TO THE SCRUB NURSE AND THE ALUMINUM PACK WAS OPENED, IT WAS FOUND THAT THE NEEDLE AND THREAD WERE DETACHED WHILE IN THE RETAINER OR HOLDER. THE DEVICE COULD NOT BE USED. A NEW PRODUCT WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18561132 ↗
• MalfunctionJan 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, AFTER OPENING THE ALUMINUM PACK, THE NEEDLE AND SUTURE BECAME DETACHED DURING THE DERMAL SUTURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18552358 ↗
• MalfunctionJul 31, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE SUTURE EASILY SLIPS OFF THE NEEDLE. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17430151 ↗
• MalfunctionJul 31, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE EASILY CAME OFF FROM THE NEEDLE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17429292 ↗
• MalfunctionJul 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHEN THE PACKAGE WAS OPENED, THE NEEDLE AND THREAD WERE NOT CONNECTED. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17339410 ↗
• MalfunctionJun 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE ROBOT ASSISTED HEPATECTOMY, WHEN THE ALUMINUM PACK WAS OPENED BY THE SCRUB NURSE TO USE THE PRODUCT FOR CLOSURE (DERMAL SUTURING), THE SUTURE HAD CAME OFF FROM THE SUTURE PART. THE DEFECTIVE PRODUCT WAS NOT USED AND A NEW PRODUCT WAS OPENED AND USED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17080434 ↗
• MalfunctionNov 30, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHEN THE PACKAGE WAS OPENED, THE NEEDLE AND THREAD HAD ALREADY COME OFF. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15888216 ↗
• MalfunctionOct 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, BEFORE USING THE DEVICE ON THE PATIENT, THE NEEDLE AND THREAD HAD CAME OFF WHEN THE USER ATTEMPTED TO USED IT AFTER OPENING THE PACKAGE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15659513 ↗
• MalfunctionApr 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN ABDOMINAL CAESAROTOMY, THE THREAD CAME OFF THE NEEDLE WHEN THE PACKET WAS OPENED. USE OF REPLACEMENT PRODUCT WAS DONE TO RESOLVE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14074388 ↗
• MalfunctionDec 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHILE SUTURING THE SKIN, THE THREAD AND THE NEEDLE CAME OFF AT THE SWAGE. NEW SUTURE FROM THE SAME PRODUCT WAS USED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 12910193 ↗
• MalfunctionNov 7, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN THE DEVICE TOOK OUT FROM THE PACKAGE PRIOR TO HYSTEROTOMY, THE NEEDLE DETACHED AS A WHOLE FROM THE SUTURE THREAD. A NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12756194 ↗
• MalfunctionSep 22, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC COLECTOMY, WHILE USING THE SUTURE FOR DERMIS CLOSURE, THE THREAD BROKE. A NEW PACKET WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12517159 ↗
• MalfunctionSep 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN ABDOMINAL SURGERY, AT THE TIMING FOR STARTING DERMAL SUTURING, THE 2 NEEDLES DETACHED FROM THE THREAD AS A WHOLE FROM THE SWAGE AND WERE NOT USED. A NEW PRODUCT WAS UTILIZED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12499908 ↗
• InjuryAug 10, 2021Break; Break

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE NEEDLE BROKE FROM THE THREE SUTURES WHEN DOING ANASTOMOSIS WITH AN ARTIFICIAL BLOOD VESSEL. ALSO WHILE DOING SUBCUTANEOUS SUTURING USING TWO SUTURES FROM ANOTHER PRODUCT MODEL, THE THREADS BROKE.

  Patient problems: Insufficient Information; Unspecified Tissue Injury

  MAUDE report 12301811 ↗
• MalfunctionAug 10, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING GYNECOLOGY/OBSTETRICS PROCEDURE, THE DEVICE THREAD BROKE WHILE THE SURGEON WAS TYING KNOT, IT HAPPENED ON 2 DEVICES. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 12300623 ↗
• MalfunctionJul 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING OBSTETRIC OPERATION CLOSURE, BOTH SUTURES WERE DISENGAGED WHEN THE NEEDLE WAS TAKEN OUT FROM THE PACKAGE. THE SAME ISSUE WAS ENCOUNTERED ON ANOTHER THE SAME PRODUCT LOT SO A REPLACEMENT DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12189897 ↗
• MalfunctionJul 8, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDICITIS SURGERY, WHEN THE USER TRIED DERMAL SUTURING, UPON OPENING OF THE FIRST PACKET, IT WAS FOUND THAT THE NEEDLE AND THREAD WERE DETACHED. IT WAS ALSO NOTED THAT THE THREAD HAD ALREADY BROKEN WHEN IT WAS OPENED ON THE OTHER 8 DEVICES ON INSPECTION. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12134991 ↗
• MalfunctionDec 13, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO A SIGMOIDECTOMY PROCEDURE, THE DEVICE'S THREAD DISENGAGED FROM THE NEEDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 9467052 ↗
• MalfunctionDec 10, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING ILEOCECAL RESECTION, WHEN THE PACK WAS OPENED IN ORDER TO USE THE PRODUCT THE THREAD WAS FOUND TO HAVE DISENGAGED FROM THE NEEDLE, A NEW PRODUCT WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9443945 ↗

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: