N/A 96-6885Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295496519), received between Aug 25, 2022 and Aug 25, 2022 — 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. How this data works · Data updated Oct 16, 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.

• MalfunctionAug 25, 2022Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THE SCRUB TECH WAS HAVING A HARD TIME PUTTING THE STEM EXTENSION ON THE TIBIAL SLEEVE BROACH. AFTER LOOKING CLOSER THE SURGEON NOTICED THAT BOTH OF THE TABS WERE BROKE OFF. ANOTHER INSTRUMENT WAS USED TO FINISH THE CASE. WHILE USING THE RACHET SCREWDRIVER THE SURGEON NOTICED THAT THE SHAFT OF THE HANDLE WAS SPINNING INSIDE OF THE SHAFT SO THEY WERE UNABLE TO TIGHTEN THE BOLT IN THE TC3 FEMORAL TRIAL. ANOTHER INSTRUMENT WAS USED TO FINISHED THE CASE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15299278 ↗