NA 04.043.415SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982298041), received between Dec 21, 2023 and Dec 21, 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 (K201336); 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.

• MalfunctionDec 21, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT ORIF WITH THE TNA NAIL AND THE GUIDE ROD FOR THE TIBIAL DIAPHYSEAL SEGMENT FRACTURE. THE GUIDE ROD WAS INSERTED, AND THEN THE NAIL WAS INSERTED AS PER REAMING AND PROCEDURE. DURING NAIL INSERTION, THERE WAS RESISTANCE IN THE COMMINUTED FRACTURE, SO HAMMERING WAS PERFORMED. WHEN THE GUIDE ROD PASSED THROUGH THE FRACTURE AND WAS INSERTED INTO THE DISTAL FRAGMENT APPROXIMATELY 3 CM, THE SURGEON TRIED TO REMOVE THE GUIDE ROD. HOWEVER, THE ROD WAS STUCK IN THE NAIL TIP AND COULD NOT BE REMOVED. AFTER SEVERAL ATTEMPTS TO PULL THE NAIL BACK AND CHANGE THE DIRECTION OF THE GUIDE ROD, THE GUIDE ROD COULD STILL NOT BE REMOVED. ONCE THE GUIDE ROD WAS REMOVED WITH THE ENTIRE NAIL. IT WAS CONFIRMED THAT THE GUIDE ROD WAS CAUGHT ON THE DISTAL POLYMER INLAY, AND THAT THE POLYMER INLAY WAS SHIFTED ABOUT 1 CM PROXIMALLY. THE SURGEON DETERMINED THAT THE NAIL COULD NOT BE USED FOR THIS PROCEDURE AND USED A NAIL WITH ANOTHER SIZE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THIS REPORT IS FOR A TIBIAL NAIL-ADVANCED / 12MM 285MM / STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18373292 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201336. 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