NA 04.045.332SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982294944), received between Mar 26, 2026 and Mar 26, 2026 — classified as 1 malfunction.

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

• MalfunctionMar 26, 2026Difficult to Advance

  IT WAS REPORTED THAT ON MARCH 9, 2026, THE PATIENT UNDERWENT ORIF WITH TNA FOR TIBIAL SHAFT FRACTURES. FOR DISTAL LOCKING, THE DRILLING FOR THE SECOND HOLE FROM THE DISTAL END OF THE NAIL WAS PERFORMED BY FREE HAND FROM THE ML DIRECTION. WHEN INSERTING THE SCREW IN QUESTION TO THE HOLE, IT WAS DIFFICULT TO ADVANCE BEYOND THE NAIL INLAY. ALTHOUGH IT TOOK TIME DUE TO THE DIFFICULTY, THE INSERTION WAS EVENTUALLY COMPLETED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN A 30-MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24699327 ↗

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