NA 04.045.040TSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982302670), received between Aug 29, 2025 and Jun 18, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K201336, K201346); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2026Insufficient Device Problem Information

  IN THE PATIENT, A PROXIMAL FEMORAL NAIL WAS IMPLANTED AT THE (B)(6) 2025, WHICH WAS BROKEN IN THE COURSE AND THEN TODAY, AT THE (B)(6) 2026, WAS REMOVED AND REPLACED BY A TOTAL HIP ENDOPROSTHESIS. IT IS OBVIOUSLY A MATTER OF MATERIAL FATIGUE DUE TO TOO WEAK A NAIL DIAMETER. THE DEVICE WAS IDENTIFIED AS STRIPPED DURING MANUFACTURERS INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25548598 ↗
• InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE INITIAL TIBIA NAIL SURGERY WITH INSERTION OF 9MM DIAMETER NAIL. THIS BECAME A NONUNION WITH TIBIA NAIL EXCHANGE TO 11MM DIAMETER.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 22921889 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201336, K201346. One submission often covers many models, so check the product and lot details in each record.

• Z-0228-2026 · Sep 26, 2025 · Open, Classified
  LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Adva
• Z-0229-2026 · Sep 26, 2025 · Open, Classified
  LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Adva