Tornier Flex MWF500SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03700386976889), received between Mar 13, 2020 and Mar 15, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Degraded” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 15, 2022Degraded; Unraveled Material; Degraded; Unraveled Material

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SCRUB TECH HAD ACCIDENTALLY CONTAMINATED THE SCREWDRIVER USED TO REMOVE THE TRAY FROM THE TRIAL STEM AND THE SURGEON ATTEMPTED TO REMOVE IT WITHOUT THE SCREW BEING FULLY BACKED OUT. THAT CAUSED THE SCREW TO STRIP THROUGH THE SURROUNDING PLASTIC THREADING. THIS CAUSED ALMOST NO DELAY IN THE PROCEDURE AND THE PATIENT DID NOT EXPERIENCE ANY HARM DUE TO THIS INSTANCE. THE SURGERY WAS A REVISION DUE TO AN OUTSIDE TRAUMA THAT THE PATIENT HAD SUFFERED. THE SURROUNDING BONE AROUND THE ORIGINAL IMPLANT WAS FRACTURED TO THE POINT WHERE A REVISION STEM WAS NEEDED TO REPLACE THE ORIGINAL STEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13774997 ↗
• InjuryMar 13, 2020Material Fragmentation; Material Fragmentation

  THE INSTRUMENT BROKE DURING SURGERY. WE HAD TO GET ANOTHER TRAY , HAS A TRAY FOR ANOTHER CASE. 35 MINUTES DELAY TO SURGERY WITH ADDITIONAL ANESTHESIA REQUIRED.

  Patient problems: Awareness During Anesthesia; No Known Impact Or Consequence To Patient

  MAUDE report 9828842 ↗