S2 1735-1140SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613153293354), received between Apr 8, 2019 and Apr 8, 2019 — classified as 1 injury.

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. 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.

• InjuryApr 8, 2019Break; Fracture; Fracture

  HOSPITAL REPORTED THE FOLLOWING EVENT: PATIENT ARRIVED IN THE EMERGENCY ROOM FOR A FEMUR NAIL THAT HAD BEEN PLACED EARLIER IN (B)(6) 2017 AND WHICH BROKE WHILE AT HOME. FEMORAL NAIL BROKEN IN HALF, CLEAN. PATIENT HAD FEVER UP TO 39°C TWICE DURING THE PROCEDURE. SURGICAL RESUMPTION BY EXTERNAL FIXATOR.

  Patient problems: Failure of Implant; Fever

  MAUDE report 8492732 ↗