NA 2178-63-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295096023), received between May 17, 2018 and Mar 19, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2020Break; Break

  IT WAS REPORTED THAT ONE OF THE TWO SPIKES ON THE MBT REVISION DRILL BUSHING WAS BROKEN OFF DURING CASE. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9856536 ↗
• MalfunctionJul 6, 2018Break; Break

  IT WAS REPORTED THAT 2 FIXATION PINS FROM THE BOTTOM BROKE OFF AFTER REAMING TIBIA. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7666157 ↗
• MalfunctionMay 17, 2018Break; Break

  IT WAS REPORTED THAT THE SPIKE PIECE ON MBT REVISION DRILL BUSHING BROKE OFF, WHEN IT CAME OUT OF STERILE PROCESSING WILL RETURN TO OFFICE AS SOON AS THEY GET REPLACEMENT. DID NOT BREAK DURING SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7521958 ↗