NA 72202868Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885554000245), received between Apr 11, 2019 and May 24, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 24, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE USING A NEEDLE FOR MENISCAL STITCHER, IT BECAME CROOKED AND WHEN TRYING TO FIX IT, THE TIP BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14483548 ↗
• InjurySep 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW "FUNCTIONAL OUTCOME OF ARTHROSCOPIC REPAIR OF BUCKET HANDLE AND LONGITUDINAL MEDIAL MENISCAL TEARS IN A MILITARY POPULATION BY INSIDE OUT AND OUTSIDE IN TECHNIQUE: A PROSPECTIVE OBSERVATIONAL STUDY", AFTER USING A MENISCAL STITCHER SET SMITH&NEPHEW DEVICE, 4 PATIENTS EXPERIENCED SUPERFICIAL SURGICAL SITE INFECTION, IT WAS TREATED WITH ANTIBIOTICS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 12465650 ↗
• MalfunctionApr 11, 2019Break

  IT WAS REPORTED THAT THE STITCHER NEEDLE BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8503545 ↗