NA 72203052Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 03596010654182), received between Jul 15, 2019 and Dec 12, 2024 — classified as 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2024Break; Break

  IT WAS REPORTED THAT DURING A DOUBLE ROW SHOULDER CUFF ARTHROSCOPY PROCEDURE, AND ALSO WHEN THE DOCTOR WENT TO CUT THE ANCHOR WIRE THE CLAMP OF THE FLUSH SUTURE CUTTER BROKE. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20914238 ↗
• MalfunctionOct 8, 2024Break; Break

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE SUTURE CUTTER BROKE. IT IS UNKNOWN HOW SURGERY WAS COMPLETED. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20402269 ↗
• MalfunctionNov 9, 2022Break; Break

  IT WAS REPORTED THAT THE SUTURE CUTTER SNAPPED IN HALF. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15762739 ↗
• InjuryOct 26, 2022Crack; Failure to Cut; Crack; Failure to Cut

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, THE FLUSH SUTURE CUTTER HAD THE TIP AT THE BOTTOM CRACKED AND IT WAS NOT CUTTING THE SUTURE THREAD. SURGERY WAS RESUMED, WITHOUT ANY SURGICAL DELAY, WITH THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15676941 ↗
• MalfunctionMay 20, 2022Break; Break

  IT WAS REPORTED THAT THE CUTTING JAW OF THE SUTURE CUTTER BROKE OFF. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14455797 ↗
• MalfunctionApr 12, 2022Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, THE SUTURE CUTTER BROKE, AT THE TIP WHERE THE THREAD ENTERS TO FINISH THE CUT, WHEN CUTTING THE WIRE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14080349 ↗
• InjuryApr 8, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY; WHEN USING THE SUTURE CUTTER, THE DEVICE BROKE, THE FORCEPS OF THE DEVICE DETACHED. THERE WAS NO PIECE LEFT IN THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A S+N BACK-UP DEVICE. THERE WAS NO SURGICAL DELAY OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14058715 ↗
• MalfunctionMay 6, 2021Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC SURGERY, THE "SUTURE CUTTER FLUSH, XL" WAS WITHOUT CUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURIES 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 11786952 ↗
• MalfunctionJan 17, 2021Break; Break

  IT WAS REPORTED THAT THE FLUSH SUTURE CUTTER X WAS BROKEN. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT. IT IS UNKNOWN IF THERE WAS A DELAY OR IF A BACKUP DEVICE WAS AVAILABLE AND HOW THE ISSUE WAS RESOLVED. 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 11183204 ↗
• MalfunctionDec 2, 2020Break; Break

  IT WAS REPORTED THAT THE FLUSH SUTURE CUTTER WAS FOUND TO BE BROKEN. INCIDENT OCCURRED AFTER THE PROCEDURE. NO DELAYS WAS REPORTED AND THE SURGERY WAS COMPLETED WITH THE SAME DEVICE. NOT PATIENT 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 10934645 ↗
• InjurySep 20, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE SUTURE CUTTER BROKE INSIDE THE PATIENT, ALL PIECES WERE REMOVED. THE PROCEDURE WAS COMPLETED WITHOUT 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; No Information

  MAUDE report 10558116 ↗
• MalfunctionAug 11, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SHOULDER ARTHROSCOPY PROCEDURE THE PRODUCT BROKE OUTSIDE THE PATIENT BUT IT DID NOT LOSE ANY PIECE. NO DELAY AND A BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. 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 10393939 ↗
• MalfunctionJul 15, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE, THE DOCTOR WAS USING THE WIRE CUTTER AND BY STRENGTHENING, THE DEVICE BROKE. PIECES WERE NOT REMOVED. THE PROCEDURE WAS COMPLETED WITH A SCALPEL WITH NO DELAY AND PATIENT INJURIES REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8787810 ↗