P.F.C. 86-6890Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295217725), received between Jul 11, 2017 and Apr 11, 2019 — classified as 3 malfunctions.

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

• MalfunctionApr 11, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT BOTH STEM TRIALS WOULD NOT STAY ATTACHED TO THE TIBIAL BROACH. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8505559 ↗
• MalfunctionApr 10, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT BOTH STEM TRIALS WOULD NOT STAY ATTACHED TO THE TIBIAL BROACH. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8501089 ↗
• MalfunctionJul 11, 2017Break; Break

  IT WAS REPORTED THAT WHILE TRYING TO REMOVE THE TIBIAL SLEEVE BROACH THE 10MM X 150MM STEM TRIAL SEPARATED OFF THE BROACH. SURGEON SCREWED THE STEM TRIAL EXTRACTOR AND TRIED PULLING OUT BEFORE ATTACHING THE EXTRACTOR AND THE THREADS BROKE OFF INTO THE TRIAL STEM. HAD TO PULL THE STEM TRIAL OUT WITH SOME RONGUERS.

  Patient problems: No Information

  MAUDE report 6701313 ↗