NA 1806-0050Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540195845), received between Jun 20, 2019 and Jun 20, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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.

• MalfunctionJun 20, 2019Difficult to Remove

  DURING HIP OSTEOSYNTHESIS SURGERY, THE 3 X 285MM KIRSCHENER NAIL REMAINED INSIDE THE FEMORAL CANAL AND IT WAS NOT POSSIBLE TO REMOVE IT, WHICH IS WHY IT REMAINS INSIDE THE PATIENT. ADDITIONAL INFORMATION: PART NUMBER 18060050 IS INSIDE THE PATIENT AND IT IS NOT BROKEN. THE K-WIRE REMAINS INSIDE THE PATIENT'S BONE. THE GAMMA3 TI NAIL WAS IMPLANTED ACCORDING TO THE TECHNIQUE THAT APPEARS IN THE CATALOG AND THE SURGEON ALWAYS PERFORMS BUT THIS WAS THE FIRST TIME THIS PROBLEM HAPPENED. THE EVENT OCCURRED DURING PRIMARY SURGERY WHICH LED TO 40 MINUTES DELAY WITHOUT ANY PATIENT IMPACT. DOCTOR DECIDE TO FINISH THE SURGERY WITH 18060050 INSIDE. DOCTOR TRIED TO REMOVE IT AT THE TIME OF THE SURGERY WITHOUT SUCCESS. BY THE END HE DECIDED TO KEEP IT INSIDE THE BONE AND HE MENTIONED HE BELIEVES IT WOULD AFFECT THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 8716033 ↗