Switchcut Reamer 4.5 x 9.5mm w/ Nitinol PassersRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10810190013882), received between Oct 19, 2017 and Jan 2, 2018 — 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.

• MalfunctionJan 2, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL SURGERY ON AN UNKNOWN DATE DUE TO OSTEOLYSIS. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO UNKNOWN REASON ON (B)(6) 2016. THE CUTTING WING ON THE REAMER BROKE OFF WHILE REAMING THE FEMORAL TUNNEL. THE REAMER WAS NO LONGER FUNCTIONAL. SURGEON REMOVED THE BROKEN PIECE FROM THE JOINT. NEW REAMER WAS OPENED AND THE SURGERY WAS COMPLETED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7156478 ↗
• MalfunctionOct 19, 2017Break; Break

  SWITCH CUT WAS REAMED ON TO GRADE FROM LATERAL CORTEX OF FEMUR IN TO FEMORAL NOTCH. REVERSED REMER TO RETROGRADE REAMER FEMORAL SOCKET AND THE SWITCH CUT BLADE CAUGHT AT THE TOP OF THE NOTCH AND BROKE OFF * 3 TIMES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6960669 ↗