MODULAR FLEXIBLE REAMER HEAD, Ø15.5mm 0234-155Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00848665000986), received between Feb 10, 2026 and Feb 10, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 18, 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.

• MalfunctionFeb 10, 2026Break

  ON 17-JAN-2026, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT A 0234-155 15.5 MM MODULAR FLEXIBLE REAMER HEAD BROKE DURING THE INTRAMEDULLARY REAMING OF A FEMORAL SHAFT. THE HIP NAIL PROCEDURE WAS COMPLETED SUCCESSFULLY; HOWEVER, THE BROKEN PIECE WAS NOT RETRIEVED FROM THE PATIENT. IT WAS REPORTED THAT THERE WAS NO OTHER PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 04-FEB-2026. THE REP ADVISED THAT THERE WERE TWO SMALL FRAGMENTS CREATED IN ADDITION TO THE LARGER REMAINING PORTION OF THE REAMER THAT WAS RETRIEVED, AND THOSE TWO FRAGMENTS REMAINED IN THE PATIENT. THE REP STATED THAT NO ATTEMPT WAS MADE TO RETRIEVE THE FRAGMENTS, AS THEY WERE MIDSHAFT AND DEEMED IMPOSSIBLE TO RETRIEVE. THERE WAS NO DELAY ENCOUNTERED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24308866 ↗