Arthrex® AR-9231-10SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867137905), received between Jan 15, 2019 and Jan 15, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 15, 2019Fracture; Unstable

  IT WAS REPORTED DURING A TOTAL SHOULDER REPLACEMENT PROCEDURE, THE SURGEON FRACTURED THE CALCAR WHILE BROACHING WITH A SIZE 10 BROACH. WHEN THE SURGEON IMPLANTED THE AR-9100-10S, UNIVERS APEX HUMERAL STEM IT WAS ROTATIONALLY UNSTABLE, AND THE SURGEON HAD TO UPSIZE TO A SIZE 11 STEM. THE CASE PROCEEDED AND WAS COMPLETED WITHOUT FURTHER ISSUE. THE REP STATED THAT THE BONE QUALITY WAS POOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED ON 12/26/2018: THE REP CONFIRMED THAT AR-9231-10S, UNIVERS APEX HUMERAL BROACH SIZE 10 WAS THE BROACH USED DURING THE PROCEDURE. THE LOT NUMBER OF THE BROACH IS UNKNOWN. THE REP STATED THAT DEVICES WERE FROM A LOANER SET OF INSTRUMENTS AND WERE ALREADY RETURNED TO ARTHREX.

  Patient problems: Bone Fracture(s)

  MAUDE report 8247785 ↗