NA 011020Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010022967), received between Feb 5, 2019 and Feb 27, 2019 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2019Difficult to Open or Close; Material Twisted/Bent; Mechanical Jam

  IT WAS REPORTED THAT DURING KNEE ARTHROSCOPY, DEVICE FRONT HANDLE PIECE WAS BENT IN BACK POSITION THEREFORE IT DID NOT COME FORWARD, IT WAS STUCK IN A LOCKED POSITION AND WILL NOT OPEN UP, THIS HAPPENED WHILE A SURGEON WAS TRYING TO RETRIEVE A LOOSE BODY IN A PATIENT, SHAFT LOOKED WARPED. PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE. THERE WAS NO SIGNIFICANT DELAY AND NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8376399 ↗
• MalfunctionFeb 5, 2019Break; Entrapment of Device

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THE PINCH BROKE INSIDE THE PATIENT'S KNEE. THEN THEY TRIED SEVERAL TIMES TO REMOVE THE PIECE BUT DID NOT SUCCEED. A CHECK WAS DONE BY X-RAYS (INTRAOPERATIVE). THIS HAS LEAD TO THE OPENING OF THE KNEE, AN INCREASE OF THE WITHERS TIME, 15 MINUTES OF OPERATIVE ARTHOSCOPIC GESTURE FOR 1H10 MINUTES OF OPENING TIME AND ANTIBIOPROPHYLAXY. IT IS UNKNOWN IF A BACK UP DEVICE WAS AVAILABLE. A DELAY GREATER THAN 2 HOURS WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8307737 ↗