Skip to content

Tornier Flex MWF621Recalls & reported problems

Tornier · Insert Revision Clamp · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03700386977411), received between Feb 14, 2018 and Feb 14, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Material Distortion” (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 13, 2026.

Most reported problems

Device problems

  • Material Distortion1

Patient problems

  • Patient Problem/Medical Problem1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 14, 2018Material Distortion; Material Distortion

    INSTRUMENT GOT STUCK IN CLOSED POSITION. WHEN THEY REMOVED THE INSTRUMENT IT BENT THE SCREW. ADDITIONAL HALF HOUR TO AN HOUR DELAY IN SURGERY AS THERE WERE ISSUES WITH REMOVING THE STUCK INSTRUMENT FROM THE HEAD. THERE WERE TWO AVAILABLE CASES SO THE SURGEON REMOVED THE WHOLE SYSTEM FROM PATIENT AND USED THE SECOND AVAILABLE CASE.

    Patient problems: Patient Problem/Medical Problem

    MAUDE report 7269439 ↗

Other CLAMP devices

All CLAMP devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.