Maxon SMM-5536Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10884523004755), received between May 4, 2017 and Sep 29, 2026 — classified as 1 injury, 46 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (37 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 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938062 ↗
• MalfunctionSep 29, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934562 ↗
• MalfunctionFeb 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE NEEDLE WAS DETACHED WHEN IT WAS BEING PULLED OUT FROM THE RETAINER AND PREPARING FOR SUTURING BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21322991 ↗
• MalfunctionDec 6, 2024Component Missing; Component Missing

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THERE WAS NO NEEDLE INSIDE THE PACKAGING. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20866349 ↗
• MalfunctionJul 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, ON TWO DEVICES, THE NEEDLE DETACHED FROM THE SUTURE AFTER REMOVING FROM THE RETAINER. ANOTHER SUTURE FROM A DIFFERENT BOX WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19792614 ↗
• MalfunctionJul 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHILE REMOVING FROM THE RETAINER PRIOR TO USE, THE NEEDLES OF TWO SUTURES DISCONNECTED P REMATURELY. ANOTHER SUTURE FROM A DIFFERENT BOX WAS USED WITHOUT ISSUES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19720471 ↗
• MalfunctionJul 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHILE REMOVING FROM THE RETAINER PRIOR TO USE, THE NEEDLES OF TWO SUTURES DISCONNECTED P REMATURELY. ANOTHER SUTURE FROM A DIFFERENT BOX WAS USED WITHOUT ISSUES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19715919 ↗
• MalfunctionJul 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, ON TWO DEVICES, THE NEEDLE DETACHED FROM THE SUTURE AFTER REMOVING FROM THE RETAINER. ANOTHER SUTURE FROM A DIFFERENT BOX WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19710433 ↗
• MalfunctionJun 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A ADNEXAL RESECTION (SALPINGO-OOPHORECTOMY), WHEN SUTURING THE SUBCUTANEOUS DERMIS, THE THREAD AND NEEDLE CAME OFF AFTER PIERCING THE TISSUE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19510723 ↗
• MalfunctionDec 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHEN THE PACKAGE WAS OPENED, THE NEEDLE WAS DETACHED FROM THE SUTURE IMMEDIATELY AFTER OPENING. IT WAS NOTED THAT ANOTHER SUTURE WAS USED SUCCESSFULLY. ANOTHER SUTURE WAS USED TO RESOLVE THE DEVICE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18251657 ↗
• MalfunctionOct 13, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC THORACOSCOPIC PULMONARY RESECTION, AT WOUND CLOSURE OR SURGICAL INCISION CLOSURE, AT THE START OF SUTURING VIA THE CONTINUOUS DERMAL SUTURE TECHNIQUE, THE THREAD BROKE. A NEW PACKAGE WAS OPENED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17932514 ↗
• MalfunctionJul 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THORACOSCOPIC LOBECTOMY, WHEN DEVICE WAS UNPACKED AND USER TRIED TO TAKE THE NEEDLE OUT, THE NEEDLE CAME OFF. ANOTHER PACKAGE WAS USED TO CONTINUE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17406842 ↗
• MalfunctionJul 10, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER,DURING A VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS), AT THE TIME OF WOUND CLOSURE WITH DERMAL SUTURE, THE NEEDLE COME OFF. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17291839 ↗
• MalfunctionApr 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC UTERINE EXTRACTION, WHEN THE SUTURE WAS TAKEN OUT FROM THE PACKAGE, THE SUTURE BROKE AND ONLY THE NEEDLE REMAINED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16744260 ↗
• MalfunctionMar 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, DURING CLOSING A SURGICAL INCISION, IMMEDIATELY AFTER OPENING THE PACKAGING FOR WOUND CLOSURE, IT WAS SEEN THAT THE SUTURE CAME OUT FROM THE NEEDLE. ANOTHER DEVICE FROM THE SAME LOT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 16529323 ↗
• MalfunctionMar 10, 2023Break; Break

  ACCORDING TO THE REPORTER, THE THREE NEEDLE WAS BREAKING.

  Patient problems: Insufficient Information

  MAUDE report 16526859 ↗
• InjuryMar 8, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GYNECOLOGICAL PROCEDURE, AFTER FASCIAL SUTURING, AT THE TIME OF SUBCUTANEOUS SUTURING OF THE UMBILICAL REGION, THE NEEDLE WAS PARTIALLY BURIED UNDERNEATH THE SKIN. THE LOCATION WAS CONFIRMED BY ABDOMINAL X-RAY, MACROSCOPICALLY REMOVED WITH FORCEPS, DEFICIT, CLOSE AFTER CHECKING THAT THERE ARE NO MISSING PIECE AND RESIDUALS. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 16503295 ↗
• MalfunctionDec 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY TO A LAPAROTOMY, WHILE PREPARING, AN ATTEMPT WAS MADE TO USE THE DEVICE BUT WHEN THE PACKET WAS OPENED, THE NEEDLE AND SUTURE WERE DISCONNECTED. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15955977 ↗
• MalfunctionNov 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PARTIAL RESECTION WITH ROBOT SUPPORT, WHILE SUTURING OF THE TROCAR WOUND, THE SUTURE OPERATIONS WERE PERFORMED WITHOUT ANY PROBLEMS WITH SEVERAL NEEDLES, BUT WHILE AT FINAL DERMAL SUTURE LIGATION IN THE FINAL STAGE, THE NEEDLE BROKE, AND THE SUTURE CAME OFF. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15747383 ↗
• MalfunctionNov 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, UPON OPENING, THE NEEDLE AND THREAD DISCONNECTED. ANOTHER SUTURE FROM THE SAME LOT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15735695 ↗
• MalfunctionAug 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE NEEDLE AND THREAD DISENGAGED WHEN THE PACKET WAS OPENED AND WHEN THE SUTURE WAS ATTEMPTED TO BE TAKEN OUT.

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

  MAUDE report 15163807 ↗
• MalfunctionJul 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, BEFORE SUTURING, THE NEEDLE AND THREAD BROKE WHEN THE NEEDLE WAS BEING HELD AND PULLED OUT WITH THE NEEDLE HOLDER.

  Patient problems: Insufficient Information

  MAUDE report 15033699 ↗
• MalfunctionJun 9, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE NEEDLE AND THREAD WERE FOUND TO BE DISENGAGED WHEN THE PACKAGE WAS OPENED. TO RESOLVE THE ISSUE, A NEW SUTURE WITHOUT ISSUE WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14649100 ↗
• MalfunctionMay 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE NEEDLE CAME OFF THE TWO SUTURES.

  Patient problems: Insufficient Information

  MAUDE report 14282277 ↗
• MalfunctionNov 16, 2021Component Missing; Component Missing

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A CVATS (COMPLETE VIDEO-ASSISTED THORACOSCOPIC SURGERY), WHEN THE NURSE WAS PREPARING THE THREAD, AND WHEN TRIED TO BE TAKEN OUT, THERE WAS NO NEEDLE AND THREAD INCLUDED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12819170 ↗

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: