NA 214622Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886705004058), received between Nov 26, 2018 and Sep 19, 2025 — classified as 7 malfunctions.

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

• MalfunctionSep 19, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE ARTHRO TISSLIB ATRAUMATIC DN DEVICE WAS BROKEN. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23095578 ↗
• MalfunctionNov 4, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN JAPAN THAT DURING ARTHROSCOPIC ROTATOR CUFF REPAIR TEAR SURGERY ON SHOULDER JOINT PROCEDURE ON AN UNKNOWN DATE, THE ARTHRO TISSLIB ATRAUMATIC DN DEVICE HANDLE AND THE BASE OF THE SHAFT BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A THIRTY MINUTE DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20599530 ↗
• MalfunctionApr 23, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING A LABRAL REPAIR PROCEDURE THE ARTHRO TISSLIB ATRAUMATIC DN DEVICE WAS BROKEN AND SHAFT WAS BENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19163865 ↗
• MalfunctionApr 5, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN JAPAN THAT DURING ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON AN UNKNOWN DATE, THE ARTHRO TISSLIB ATRAUMATIC DN DEVICE BROKE. IT WAS REPORTED THAT THE X-RAY SHOWED THERE WERE NO BROKEN PIECES IN THE BODY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19053494 ↗
• MalfunctionNov 13, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER SCOPE PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE TISSUE LIBERATOR ATRAUMATIC DOWN DEVICE SNAPPED IN TWO. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15786194 ↗
• MalfunctionSep 4, 2019Break; Break

  DEVICE REPORT FROM SYNTHES MITEK REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ARTHROSCOPIC STABILISATION / LATARJET PROCEDURE; DAMAGED INSTRUMENT, FROM CONSIGNMENT INSTABILITY TRAY. DURING THE PROCEDURE, WHILST MOBILISING TISSUE AROUND THE PATIENT'S GLENOID, THE SHAFT OF THE LIBERATOR BROKE OFF THE HANDLE. THE SEPARATION OF THE 2 PIECES OCCURRED OUTSIDE OF THE PATIENT'S BODY, SO NO FRAGMENTS (NO FRAGMENTS ACTUALLY PRODUCED, AS BREAK WAS CLEAN) WERE ABLE TO ENTER THE WOUND. ACTION TAKEN: SOURCE ALTERNATE INSTRUMENT FROM 2ND TRAY. 3 MINUTE DELAY TO THE PROCEDURE. NO AE TO PATIENT. PATIENT OUTCOME POST SURGERY: STABLE SHOULDER JOINT. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8962923 ↗
• MalfunctionNov 26, 2018Break; Break

  THE SALES REPRESENTATIVE REPORTED THAT THE CUSTOMER¿S TISSUE LIBERATOR ATRAUMATIC-DOWN BROKE IN HALF DURING THE PROCEDURE; IT WAS NOTED THE DEVICE WAS NOT IN THE PATIENT AT THE TIME. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE, WITH NO DELAY AND NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8102573 ↗