NA 72202588Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010652430), received between Mar 20, 2020 and May 17, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 17, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TIP OF THE XL SUTURE CUTTER FELL INTO THE PATIENT'S BODY, THE PIECES REMAINED IN THE PATIENT AND WERE NOT REMOVED. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A NON-SIGNIFICANT DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14421522 ↗
• MalfunctionMar 20, 2020Contamination; Contamination

  IT WAS REPORTED THAT DURING A HIP PROCEDURE WHEN THE SUTURE CUTTER CUTS IT LEAVES BLACK DUST. NO DELAY AND A BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. 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: Foreign Body In Patient

  MAUDE report 9862719 ↗