Arthrex® AR-2167-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867026063), received between Jan 24, 2022 and Sep 19, 2023 — classified as 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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2023Break; Break

  ON 8/24/2023, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS-06015094 THAT AN AR-2167-2 PENETRATOR SUTURE RETRIEVER WAS BROKEN; THE PLIERS HAD A BROKEN TIP. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT AND THE CASE WAS DELAYED FOR FIVE MINUTES. THE CASE WAS COMPLETED USING ANOTHER DEVICE. THIS WAS DISCOVERED DURING A SHOULDER PROCEDURE ON (B)(6) 2023, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17775130 ↗
• MalfunctionJan 24, 2022Break

  ON 10/29/2021, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-2167-2 SUTURE RETRIEVER BROKE. THIS OCCURRED DURING A SHOULDER RCR ON (B)(6) 2021. THE CASE WAS COMPLETED USING A SPARE INSTRUMENT, WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13333609 ↗