NA 390191Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 37613327072625), received between Jan 8, 2019 and Jan 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 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.

• InjuryJan 8, 2019Break; Difficult to Remove

  AT 10:45 IN (B)(6) 2018, THE PATIENT WAS TREATED WITH CLOSED REDUCTION AND KIRSCHNER WIRE INTERNAL FIXATION FOR THE FRACTURE OF THE DISTAL RIGHT FEMUR DUE TO THE FRACTURE OF THE EXTERNAL END OF THE RIGHT FEMUR. WHEN THE DOCTOR GAVE THE PATIENT THE THIRD KIRSCHNER WIRE, THE KIRSCHNER WIRE BROKE AND HALF OF THE KIRSCHNER WIRE BROKE IN THE BONE. AT 11:30, THE DOCTOR CUT THE PATIENT'S SKIN AND PART OF THE CARTILAGE AT THE NEEDLE POINT, SEARCHED FOR THE KIRSCHNER WIRE BROKEN IN THE BONE, AND TOOK IT OUT AND SUTURED THE SKIN. THE OPERATIVE TIME WAS 12:32. THE OPERATION WAS ORIGINALLY A CLOSED REDUCTION OPERATION. BECAUSE THE KIRSCHNER WIRE WAS BROKEN IN THE PATIENT'S BONE, THE OPERATION METHOD HAD TO BE CHANGED TO OPEN REDUCTION.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8228632 ↗