NA 2178-63-185Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295096429), received between Apr 10, 2018 and Feb 12, 2019 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2019Break; Break

  IT WAS REPORTED THAT THE INSTRUMENTS ARE BROKEN AND CANNOT BE USED FOR SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8331464 ↗
• MalfunctionMay 24, 2018Connection Problem; Connection Problem

  IT WAS REPORTED THAT WHEN PASSING THE CEMENTED REAMER THROUGH THE BUSHING IT GOT STUCK AND WOULD NOT CONTINUE REAMING. NEED NEW PARTS SENT TO (B)(6) WAREHOUSE.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7542093 ↗
• MalfunctionApr 26, 2018Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE REVISION CHUCK WOULD NOT ATTACH PROPERLY TO THE REAMER. IT WOULD NOT SEAT DOWN CORRECTLY AND WAS NOT ABLE TO BE USED. IT DID NOT DELAY OUR SURGERY SINCE WE HAD ANOTHER REAMER THAT WE COULD USE IN ITS PLACE. IT WAS JUST ONE PIECE SO IT WILL BE RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7464702 ↗
• MalfunctionApr 10, 2018Break; Naturally Worn; Break; Naturally Worn

  DER STATES THAT INSTRUMENTATION BROKE IN SURGERY AND ALL PIECES WERE REMOVED FROM THE PATIENT WITH NO DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7411601 ↗