Arthrex® AR-9401-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867060302), received between Jul 14, 2021 and May 25, 2024 — classified as 1 injury, 2 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 18, 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.

• MalfunctionMay 25, 2024Break; Break

  ON 03/22/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT ONE OF THE AR-9401-11 RESECTION GUIDES VERSION RODS SNAPPED OFF WITHIN THE GUIDE AND IT CANNOT BE FISHED OUT. THIS OCCURRED DURING AN UNKNOWN TIME, WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19398290 ↗
• MalfunctionMay 24, 2024Break; Break

  ON 04/24/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AN AR-9401-11 RESECTION GUIDE PIN BROKE AND THE THREAD STAYED INSIDE THE GUIDE. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: Insufficient Information

  MAUDE report 19392048 ↗
• InjuryJul 14, 2021Difficult to Remove; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PIN GOT STUCK WITHIN THE AR-9401-11 GUIDE. THE REP PRIED AND PULLED TRYING TO REMOVE THE PIN, BUT NO AVAIL. THE SURGEON FINISHED THE CASE BY DOING A FREE HAND CUT.

  Patient problems: Foreign Body In Patient

  MAUDE report 12165218 ↗