NA 04.233.024SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982289094), received between Aug 18, 2023 and Aug 18, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K201346, K233696); 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.

• MalfunctionAug 18, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6)2023, SURGEON INSERTED AN RFNA 10 X 240 RFNA. AFTER INSERTION OF THE NAIL, CANNULATED SCREWS WERE INSERTED. SCREWS WERE SPINNING WHEN INSERTED WITH SCREWDRIVER AND MEASUREMENT WAS LONG. WHEN INSERTING LM SCREW IN RFNA, IT MISSED THROUGH JUST DUE TO WIRE DEFLECTING. SURGEON TOOK OUT WIRE AND STILL MISSED. SO SURGEON USED A LONGER RFNA NAIL AND IT SEEMED TO GO THROUGH. 10 X 240 RFNA WAS NOT BILLED TO PATIENT AND CAN BE SENT BACK. SURGEON WANTED SCREWDRIVERS, DEPTH GAUGE AND DRILL GUIDE REPLACED. THERE WAS 3 MINUTES SURGICAL DELAY. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) RFNA/ 10MM/ 240MM/ STANDARD BEND/ STER THIS IS REPORT 1 OF 3 FOR COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17576953 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201346, K233696. 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