NA 04.045.038SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982294418), received between Oct 18, 2022 and Oct 18, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Migration” (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. How this data works · Data updated Oct 13, 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.

• InjuryOct 18, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022 THERE WAS A REVISION OF TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) FOR CONVERSION TO TOTAL HIP DUE TO CUT OUT. THERE WAS NO SURGICAL DELAY, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) LOCKING SCREW FOR IM NAIL Ø 5MM/ 38MM/ XL25/ STERILE. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15620831 ↗

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