NA 0193-3200Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540678522), received between May 7, 2020 and May 7, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2020Fracture; Fracture

  IT WAS REPORTED: TODAY WE WERE DOING A FEMORAL NAIL ON A (B)(6) YEAR OLD MALE AT (B)(6) THE SURGEON WAS HAVING A DIFFICULT TIME REDUCING THE FEMUR SO WE GRABBED THE ¿F TOOL¿ ((B)(4)) TO HELP WITH REDUCTION. SHE HAD TO APPLY A FAIR AMOUNT OF FORCE TO REDUCE THE FEMUR BACK TOGETHER AND AS A RESULT, ONE OF THE BLACK PIECES THAT CONNECTS TO THE LARGER ROD BROKE RIGHT AROUND THE BASE OF THE THREADS. WE WERE ABLE TO FIND A SUBSTITUTE TOOL AND CONTINUE WITH THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10035134 ↗