S2 1725-0933SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540396136), received between Jul 16, 2018 and Jul 16, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 18, 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.

• InjuryJul 16, 2018Material Twisted/Bent

  THE PHARMACIST AT THE HOSPITAL REPORTED THE FOLLOWING EVENT: "THE NAIL WAS INSTALLED DUE TO A LONG SPIRAL FRACTURE OF THE RIGHT LEG. AFTER A X-RAY CHECK UP DURING THE INTERVENTION, THE SURGEON NOTICED THAT THE NAIL WAS BENTED AND REPLACED IT RIGHT AWAY BY AN NAIL OF 10MM INSTEAD OF 9MM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7691483 ↗