NA 04.045.078SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982294616), received between Jan 27, 2023 and Jan 27, 2023 — 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. 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 27, 2023Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO IMPLANT A RETROGRADE ADVANCED NAIL WITH REGULAR 5.0 LOCKING SCREW. THEN, APPROXIMATELY TWO WEEKS LATER ON (B)(6) 2023, THE PATIENT WAS RUSHED IN THE ER COMPLAINING ABOUT PAIN. THE MOST DISTAL SCREW OF THE NAIL HAD BACKED OUT, SO THE ANS SCREW WAS TAKEN OUT AND REPLACED WITH A 5.0 LOCKING SCREW. THE SURGEON PUT THE CAP ON THE NAIL TO AVOID ANY TAGGLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE UNK - SCREWS: NAIL DISTAL LOCKING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 16257982 ↗

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-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
• 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