NA 72203053Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010653666), received between Mar 15, 2019 and May 22, 2026 — classified as 4 injuries, 5 malfunctions.

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

• MalfunctionMay 22, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF PROCEDURE, THE HANDLE OF THE SUTURE CUTTER BROKE. ALL THE PIECES WERE REMOVED. THE PROCEDURE WAS RESUMED, WITH A SIGNIFICANT DELAY, USING AN ARTHREX COMPETITOR DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25257381 ↗
• InjurySep 7, 2022Crack; Crack

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SUTURE CUTTER METAL CRACKED AT DISTAL END OF TOOL, AS IT WAS UNABLE TO CUT THE SUTURE. THERE WAS A PHYSICAL BREAKAGE PRESENT. THERE WAS NO LOSS OF MATERIAL, BUT THE CUTTER PUSHED THE SUTURE THROUGH THE CRACK IN MATERIAL. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15375570 ↗
• InjuryOct 27, 2021Crack; Crack

  IT WAS REPORTED THAT, DURING A SURGERY, THE FLUSH SUTURE CUTTER LOWER JAW WAS CRACKED SO THE SUTURE COULD NOT BE CUT. NO DELAY WAS REPORTED. IT IS UNKNOWN IF THERE WAS SIGNIFICANT DELAY. IT IS UNKNOWN IF THERE WAS SIGNIFICANT DELAY. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12707895 ↗
• InjuryFeb 22, 2021Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT DURING A SHOULDER LABRAL REPAIR SURGERY, THE FLUSH CUTTER WOULD NOT OPEN AND CLOSE PROPERLY AND A SMALL PART AT THE FRONT END BECAME SEPARATED FROM THE MAIN SHAFT. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP 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 11362046 ↗
• MalfunctionFeb 5, 2021Break; Break

  IT WAS REPORTED THAT THE TIP OF THE FLUSH SUTURE CUTTER WAS SPLIT AND THE SUTURE IS SLIPPING THROUGH. NO CASE WAS INVOLVED. 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 11283830 ↗
• MalfunctionOct 18, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE FLUSH SUTURE CUTTER HAD JAW ISSUES, IT DID NOT OPEN. NO CASE WAS INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10694710 ↗
• InjuryAug 14, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE FLUSH SUTURE CUTTER BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. 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 Information

  MAUDE report 10410800 ↗
• MalfunctionJul 30, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING THE SET UP INSPECTION, THE CUTTING PIECE BROKE OFF OF THE SUTURE CUTTER. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO DELAY AND NO PATIENT INJURIES WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10343863 ↗
• MalfunctionMar 15, 2019Break

  IT WAS REPORTED THAT DURING THE SURGERY, THE DOCTOR PROCEEDED TO CUT A SUTURE AND THE BASE OF THE CUTTER BROKE INSIDE THE PATIENT, ALL THE PIECES WERE REMOVED. THERE WERE NO DELAYS OR PROBLEMS AS THERE WAS ANOTHER CUTTER AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8425090 ↗