NA 214008Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705020195), received between Dec 22, 2020 and May 26, 2021 — 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.

• MalfunctionMay 26, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER SCOPE PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE ARTHROSCOPIC SOFT TISSUE LIBERATOR DEVICE WAS BROKEN. ALL FRAGMENTS WERE RETRIEVED AND ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11886078 ↗
• MalfunctionDec 22, 2020Difficult to Open or Close; Mechanical Jam; Difficult to Open or Close; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE ARTHROSCOPIC SOFT TISSUE LIBERATOR DEVICE REPAIR SPRING WAS STIFF AND IT WAS HARD TO OPEN AND CLOSE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO SURGICAL DELAY OR PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11055205 ↗