NA 214623Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886705004065), received between Sep 5, 2018 and Apr 5, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2023Material Deformation; Material Deformation

  THIS IS REPORT 4 OF 4 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT DURING AN ARTHROSCOPIC SHOULDER STABILIZATION PROCEDURE ON (B)(6), IT WAS OBSERVED THAT THE TISSUE LIBERATOR BLADE UP DEVICE WAS BENT. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16685699 ↗
• MalfunctionMay 21, 2020Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT DURING AN UNKNOWN SURGERY THE TISSUE LIBERATOR BLADE UP AND THE TISSUE LIBERATOR BLADE DOWN OF THE SHOULDER EQUIPMENT SPLITTED WHILE THE DOCTOR TRIED TO DISSECT THE LABRUM. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. LOT NUMBERS ARE UNKNOWN. THE DEVICES ARE AVAILABLE FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10080546 ↗
• MalfunctionJan 30, 2019Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER SCOPE SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE HANDLE ON THE TISSUE LIBERATOR SEPARATED FROM THE SHAFT. THE DEVICE BROKE STAYED OUTSIDE THE PATIENT AND CONFIRMED THAT NO DEBRIS FELL IN THE PATIENT. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAYS. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8288663 ↗
• MalfunctionSep 5, 2018Break; Break

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE DURING A SHOULDER REPAIR THE CUSTOMER'S TISSUE LIBERATOR BLADE UP BROKE IN HALF WHILE IN THE PATIENT. THE SURGEON REMOVED ALL THE PIECES AND NO X-RAYS WERE DONE. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAYS. ADDITIONAL INFORMATION RECEIVED BY MITEK COMPLAINTS ON (B)(6) 2015: THE SALES REP CONFIRMED THAT THE DEVICE BROKE WHERE THE HANDLE MEETS THE METAL SHAFT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7847997 ↗