NA 72202589Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 03596010652447), received between May 7, 2020 and Feb 23, 2024 — classified as 3 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (8 reports).

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2024Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT THE SUTURE CUTTER HAD A LOCKED PIECE AND IT WAS NOT WORKING PROPERLY. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18771368 ↗
• MalfunctionFeb 23, 2024Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE SUTURE CUTTER WAS NOT WORKING PROPERLY. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. PER THE PRELIMINARY RESULTS OF THE INVESTIGATION, THE VISUAL INSPECTION SHOWS THE DISTAL END OF THE CUTTING SHAFT IS FRACTURED AWAY FROM THE PROXIMAL END THAT IS ATTACHED TO THE HANDPIECE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18771365 ↗
• MalfunctionFeb 16, 2024Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT DURING SET UP, THE SUTURE CUTTER WAS FOUND TO BE LOCKED. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. THERE WAS NO PATIENT INVOLVEMENT. PER THE PRELIMINARY RESULTS OF THE INVESTIGATION, THE VISUAL INSPECTION SHOWED THE DISTAL END OF THE CUTTING SHAFT IS FRACTURED AWAY FROM THE PROXIMAL END THAT IS ATTACHED TO THE HANDPIECE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18721595 ↗
• InjuryAug 9, 2021Corroded; Mechanical Jam; Corroded; Mechanical Jam

  IT WAS REPORTED THAT, THE HEAD POSITION OF THE SUTURE CUTTER, DOES NOT PASS THROUGH THE WIRE. IT IS UNKNOWN WHEN THE ISSUE WAS FOUND. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO DELAY AND NO PATIENT INJURIES WERE REPORTED. PRELIMINARY RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT HAD RUST AND DEBRIS WHICH MAKES IT A REPORTABLE EVENT SINCE INDICATES THE DEVICE WAS USED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12297904 ↗
• MalfunctionMay 20, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION, THE SUTURE CUTTER GOT STUCK. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11859579 ↗
• InjuryApr 14, 2021Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SUTURE CUTTER WAS DULL. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE. NO DELAY AND NO PATIENT COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11667340 ↗
• MalfunctionJan 7, 2021Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE SUTURE CUTTERS WAS BLUNT AND IT WAS NOT WORKING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY CHANGING THE SURGICAL TECHNIQUE. NO DELAYS NOR FURTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11135278 ↗
• MalfunctionJan 7, 2021Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE SUTURE CUTTERS WAS BLUNT AND IT WAS NOT WORKING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY CHANGING THE SURGICAL TECHNIQUE. NO DELAYS NOR FURTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11135273 ↗
• MalfunctionJan 7, 2021Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE SUTURE CUTTERS WAS BLUNT AND IT WAS NOT WORKING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY CHANGING THE SURGICAL TECHNIQUE. NO DELAYS NOR FURTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11135233 ↗
• MalfunctionJan 7, 2021Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE SUTURE CUTTERS WAS BLUNT AND IT WAS NOT WORKING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY CHANGING THE SURGICAL TECHNIQUE. NO DELAYS NOR FURTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11135219 ↗
• MalfunctionJan 7, 2021Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE SUTURE CUTTERS WAS BLUNT AND IT WAS NOT WORKING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY CHANGING THE SURGICAL TECHNIQUE. NO DELAYS NOR FURTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11135206 ↗
• InjuryDec 23, 2020Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE SUTURE CUTTER'S PLASTIC PIECE BROKE OFF WHEN THEY TESTED THE SUTURE CUTTER. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A COMPETITOR DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11070329 ↗
• MalfunctionAug 24, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT DURING CHECKING BEFORE USING THE DEVICE, THE SUTURE CUTTER HAD BEEN DULL AND POOR OF SHARPNESS. NO DELAY AND IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10446062 ↗
• MalfunctionJul 8, 2020Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING A CL RECONSTRUCTION SURGERY THE SUTURE CUTTER DID NOT CUT THE SUTURE. NO PATIENT INJURIES OR SIGNIFICANT DELAY WAS REPORTED. SURGERY WAS COMPLETED USING A SMITH AND NEPHEW BACK-UP DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10244444 ↗
• MalfunctionMay 7, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT DURING SURGERY THE SUTURE CUTTER WAS DULL AND POOR OF SHARPNESS. NO DELAY AND THERE WAS NO BACK UP AVAILABLE. ALTHOUGH NO BACKUP DEVICE IS REPORTED, THERE IS NO INFORMATION THAT REASONABLY SUGGESTS A PROCEDURE CANCELLATION, CHANGE IN SURGICAL TECHNIQUE NOR USE OF COMPETITOR DEVICE OCCURRED. NO PATIENT INJURY WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10037158 ↗