Arthrex® AR-9236-04PPRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888867250703), received between Mar 8, 2021 and Mar 18, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Material Fragmentation

  ON 25-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT THE AR-9236-04PP UNIVERS VAULTLOCK GLENOID TRIAL HAD PIECES FRAGMENT DURING A CASE AND WERE RETRIEVED. THIS ISSUE WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24625852 ↗
• MalfunctionJul 28, 2023Break; Break

  ON 06/29/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9236-04PP GLENOID TRIAL BROKE. THIS OCCURRED DURING A CASE, THE TRIAL BROKE WHEN BEING REMOVED FROM THE GLENOID. THE DOCTOR WAS ABLE TO RETRIEVE ALL PIECES FROM THE PATIENT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17414044 ↗
• MalfunctionMar 27, 2023Break; Break

  ON 3/8/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9236-04PP BROKE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023 WITH NO PATIENT HARM.

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

  MAUDE report 16617667 ↗
• MalfunctionFeb 14, 2022Break

  ON (B)(6) 2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9236-04PP BROKE DURING A CASE, PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13529127 ↗
• MalfunctionNov 30, 2021Break

  ON (B)(6) 2021, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT A AR-9236-04PP GLENOID TRIAL BROKE. THIS WAS DISCOVERED DURING A CASE WHEN IT WAS NOTICED THAT THE PEGS ON THE BACK HAD BROKEN-OFF.

  Patient problems: Insufficient Information

  MAUDE report 12897707 ↗
• MalfunctionNov 8, 2021Break

  ON (B)(6) 2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9236-04PP GLENOID TRIAL BROKE DURING AN ECLIPSE TSA PROCEDURE. DURING THE REMOVAL OF THE TRIAL FROM THE GLENOID THE CENTER PEG SNAPPED OFF. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT AND THE CASE WAS COMPLETED SUCCESSFULLY. NO ADVERSE AFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12770657 ↗
• MalfunctionJun 7, 2021Break

  IT WAS REPORTED DURING AN APEX TOTAL SHOULDER, THE CENTRAL PEG OF THE AR-9236-04PP XTRA LARGE VAULTLOCK TRIAL BROKE OFF WHILE INSERTING INTO THE GLENOID. THE REP REPORTED ALL PIECES WERE RETRIEVED AND THERE WAS NO PATIENT HARM. THE TRIAL WAS NOT NEEDED AFTER THE MALFUNCTION, AND THE CASE WAS COMPLETED IN NORMAL FASHION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11946668 ↗
• MalfunctionMay 24, 2021Break

  IT WAS REPORTED ONE OF THE TABS BROKE OFF WHEN IT WAS BEING IMPACTED. THIS WAS DISCOVERED AFTER THAT PART OF THE PROCEDURE WAS COMPLETED. THE TAB WAS RETRIEVED AND THE CASE WAS COMPLETED WITH NO FURTHER ISSUES. THE PATIENT IS FINE TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11871684 ↗
• MalfunctionMay 18, 2021Break

  IT WAS REPORTED THAT THE AR-9236-04PP CENTRAL PEG BROKE OFF UPON REMOVAL OF THE TRIAL.

  Patient problems: Insufficient Information

  MAUDE report 11842510 ↗
• MalfunctionMar 8, 2021Break

  IT WAS REPORTED DURING AN APEX TOTAL SHOULDER REPAIR THE AR-9236-04PP CENTER PEG BROKE WHEN TRYING TO REMOVE. ALL PIECES WERE RETRIEVED WITH NO ISSUES TO CASE. AR-9231-20 WAS NOT WORKING ON BROACH AND VERSION ROD ANGLES WERE OFF. THESE ITEMS WERE REPLACED AND THE CASE WAS COMPLETED AND THE PATIENT IS FINE TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11437148 ↗