Arthrex® AR-9545Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867141636), received between Jan 3, 2023 and Nov 29, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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.

• MalfunctionNov 29, 2023Break; Break

  ON 11/2/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9545 UNIVERS REVERS REDUCTION HELPER HAD A PIECE SNAP OFF. THE CASE WAS COMPLETED USING A DIFFERENT PRODUCT. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION RECEIVED ON 11/7/2023: THE AR-9545 UNIVERS REVERS REDUCTION HELPER HAD A PIECE SNAP OFF INSIDE THE PATIENT. ALL FRAGMENTS WERE RETRIEVED. THERE WAS NO REPORTED DELAY IN THE CASE. THE CASE CONTINUED AND THE AR-9545 UNIVERS REVERS REDUCTION HELPER WAS NO LONGER NEEDED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A RTSA PROCEDURE ON 11/1/2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18229177 ↗
• MalfunctionJul 13, 2023Break; Break

  ON 06/14/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9545 REDUCTION HELPER PLASTIC SHOEHORN BROKE OFF. THIS WAS DISCOVERED DURING A CASE, DEVICE BROKE DURING USE. ALL FRAGMENTS REMOVED

  Patient problems: Insufficient Information

  MAUDE report 17315917 ↗
• MalfunctionMay 4, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9545 GLENOSPHERE REDUCTION TOOL BROKE. THIS OCCURRED DURING A CASE ON (B)(6) 2023, A BACKUP WAS USED TO COMPLETE THE CASE. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION WAS PROVIDED ON (B)(6) 2023, IT WAS REPORTED THAT THIS EVENT OCCURRED DURING A TSA CASE. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16870904 ↗
• MalfunctionJan 3, 2023Break

  ON 12/16/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-9545 GLENOSPHERE REDUCTION TOOL BROKE. THIS OCCURRED DURING A CASE IN THE MIDDLE OF TRAILING AN ECLIPSE HEAD SIZE, THE SURGEON WANTED TO DISLOCATE THE SHOULDER AND REMOVE THE TRIAL, WHEN THE RETRACTOR SNAPPED. THE BROKEN PIECE WAS RETRIEVED AND SET ASIDE, ANOTHER RETRACTOR WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16087491 ↗