NA 04.045.095Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982293411), received between Mar 2, 2023 and Mar 2, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (2 reports).

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

• InjuryMar 2, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PATIENT HAD 2 DISTAL SCREWS IMPLANTED THAT WERE TOO LONG IN INITIAL SURGERY. PATIENT WAS COMPLAINING ABOUT PAIN AFTER INITIAL SURGERY. SURGEON REMOVED THE SCREWS DURING THIS SURGERY (SURGERY #2) THAT WERE INCORRECT IN LENGTH, AND REPLACED THEM WITH SHORTER LENGTH SCREWS. THERE WAS A PATIENT OUTCOME OR CONSEQUENCE. THE PATIENT WAS COMPLAINING OF PAIN. THERE WAS OTHER MEDICAL INTERVENTION. ADDITIONAL SURGERY TO REMOVE THE SCREWS THAT WERE TOO LONG AND IMPLANT APPROPRIATE-LENGTH SCREWS. THIS REPORT IS FOR ONE (1) LOCKING SCREW FOR IM NAIL 5/ 95/ XL25. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 16467381 ↗
• InjuryMar 2, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PATIENT HAD 2 DISTAL SCREWS IMPLANTED THAT WERE TOO LONG IN INITIAL SURGERY. PATIENT WAS COMPLAINING ABOUT PAIN AFTER INITIAL SURGERY. SURGEON REMOVED THE SCREWS DURING THIS SURGERY (SURGERY #2) THAT WERE INCORRECT IN LENGTH, AND REPLACED THEM WITH SHORTER LENGTH SCREWS. THERE WAS A PATIENT OUTCOME OR CONSEQUENCE. THE PATIENT WAS COMPLAINING OF PAIN. THERE WAS OTHER MEDICAL INTERVENTION. ADDITIONAL SURGERY TO REMOVE THE SCREWS THAT WERE TOO LONG AND IMPLANT APPROPRIATE-LENGTH SCREWS. THIS REPORT IS FOR ONE (1) LOCKING SCREW FOR IM NAIL 5/ 95/ XL25 THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 16467359 ↗

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