FLEXIBLE REAMER SHAFT 2.0mm 0222-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00848665023688), received between Sep 14, 2021 and Mar 6, 2025 — 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 18, 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.

• MalfunctionMar 6, 2025Break; Break

  ON 02/21/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN 0222-200 FLEXIBLE REAMER SHAFT BROKE. THIS OCCURRED DURING A CASE WHERE THE PIECE WAS RECOVERED AND THE CASE WAS COMPLETED WITH NO ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21537400 ↗
• MalfunctionSep 14, 2021Break; Defective Device; Noise, Audible; Separation Problem

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT THE 0222-200 WAS FOUND DEFECTIVE AND UNUSABLE. NO CASE INVOLVEMENT. ADDITIONAL INFORMATION PROVIDED 8/27/2021: STARTED FLEX REAMER FROM AOS HUMERAL NAIL SET AT 6.5MM THROUGH A 10.5MM ENTRY HOLE DOWN THE HUMERAL CANAL. SURGEON IMMEDIATELY NOTICED A ¿CHATTER¿ SOUND WHICH THEN SIZED UP REAMERS BY .5MM UNTIL THEY REACHED 8. THROUGHOUT UPSIZED REAMING, SURGEON NOTICED THE SAME ¿CHATTER" SOUND. HALFWAY DOWN HUMERAL CANAL, FLEX REAMER BROKE AND REVEALED A FAULTY FLEX REAMER BASE WHICH HAD SEPARATED FROM THE FLEX SHAFT LEAVING AO CONNECT IN DRILL HAND PIECE. THE CASE WAS COMPLETED BY USING AN AOS TIBIA/FEMORAL FLEX REAMERS SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12467672 ↗