NA 214624Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886705004072), received between Jan 23, 2019 and Sep 4, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2024Break; Break

  IT WAS REPORTED FROM COLOMBIA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE ARTHRO TISSLIB BLADE DOWN DEVICE BROKE DURING THE RELEASE INTO THE LABRUM. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20137685 ↗
• MalfunctionApr 5, 2023Material Deformation; Material Deformation

  THIS IS REPORT 3 OF 4 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT DURING AN ARTHROSCOPIC SHOULDER STABILIZATION PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE TISSUE LIBERATOR - BLADE DOWN 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 16685701 ↗
• MalfunctionDec 19, 2022Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CANADA THAT THE TISSUE LIBERATOR BLADE DOWN DEVICE WAS BROKEN. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16005478 ↗
• MalfunctionApr 18, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE AFFILIATE IN COLOMBIA THAT DURING AN UNKNOWN SURGERY (B)(6) 2022, IT WAS OBSERVED THAT THE ARTHRO TISSLIB BLADE DOWN DEVICE HAD A BENT TIP AND ITS DIRECTION OF THE FOLD WAS NOT CORRECT. 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 14135533 ↗
• MalfunctionJul 28, 2020Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A SHOULDER STABILIZATION SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE ARTHRO TISSLIB BLADE DOWN EA DEVICE SNAPPED AT THE HANDLE JUNCTION. THERE WAS NO DELAY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10332394 ↗
• 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 10080581 ↗
• MalfunctionJan 23, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP THAT THE CUSTOMER¿S TISSUE LIBERATOR BROKE AT THE HANDLE AND CORD CUTTER WAS STICKING AND NOT RELEASING WHEN CUTTING DURING A SHOULDER ARTHROSCOPY PROCEDURE. THE CASE WAS COMPLETED USING ANOTHER LIKE DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES OR DELAY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8270613 ↗