Arthrex® AR-9532-36Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867241596), received between Apr 5, 2021 and Mar 18, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER PROSTHESES SURGERY THE GUIDE BROKE INTO TWO PIECES OUTSIDE THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITHOUT AN ADDITIONAL DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21632870 ↗
• MalfunctionJul 3, 2024Break; Break

  ON (B)(6)2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA (B)(6) . THAT AN AR-9532-36 UNIVERS REVERS¿ HUMERAL CUP SCREW GUIDE BROKE IN HALF. THIS OCCURRED DURING A CASE. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: Insufficient Information

  MAUDE report 19669600 ↗
• MalfunctionApr 5, 2021Crack

  IT WAS REPORTED THAT THE AR-9532-36 CRACKED DURING A PROCEDURE. NO PATIENT HARM. THIS IS NOW REPORTABLE. DURING RETURNED DEVICE EVALUATION, A REPORTABLE MALFUNCTION WAS DISCOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11613238 ↗