NA 71366603Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010199942), received between Feb 13, 2019 and Feb 19, 2021 — classified as 3 malfunctions.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE TRIAL IS STRIPPED AND NEEDS TO BE REPLACED. FAILURE WAS NOTICED DURING USE AND THE PROCEDURE WAS COMPLETED USING A SN DEVICE. NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11347214 ↗
• MalfunctionDec 17, 2020Material Separation; Connection Problem; Material Separation; Connection Problem

  IT WAS REPORTED THAT, DURING A THR SURGERY, INSTRUMENTS OUTSIDE PATIENT, THE THREADING OF THE SLEEVE CAME OFF AND AS A RESULT GOT STUCK IN THE UNIPOLAR SHELL TRIAL. NO SURGICAL DELAY OR INJURY TO PATIENT REPORTED DUE THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11032942 ↗
• MalfunctionFeb 13, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE DEVICE BROKE WHILE BEING USED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS A PATIENT IMPACT DUE TO THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8337961 ↗