ACUFEX 7209494Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010474490), received between Oct 14, 2020 and Oct 28, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2025Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, WHEN THE SURGEON USED THE SUTURE MANIPULATOR TO RETRIEVE THE ANCHOR WIRES, IT BROKE IN HIS HAND. THE DOCTOR MANAGED TO REMOVE THE PIECES THAT FELL ON THE PATIENT. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING THE SAME FAULTY DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23402877 ↗
• MalfunctionJun 24, 2025Break; Difficult to Open or Close; Break; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SUTURE MANIPULATOR WAS DAMAGED AND STOPPED CLOSING COMPLETELY, IT BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22324018 ↗
• MalfunctionFeb 20, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACL ARTHROSCOPY, THE SUTURE MANIPULATOR CLAMP WAS DAMAGED AND BROKEN. NO PIECES FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACKUP DEVICE, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21422729 ↗
• InjuryJan 28, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT, DURING A SHOULDER SURGERY, THE GRIPPER OF THE "SUTURE MANIPULATOR" DID NOT FULLY CLOSED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY THROUGH A CHANGE IN THE SURGICAL TECHNIQUE. NO 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 11246879 ↗
• MalfunctionOct 14, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE SUTURE MANIPULATOR WAS CLOSED AND CAN NOT BE OPENED. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 10675814 ↗