NA 04.043.015SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982297440), received between Jun 21, 2022 and Dec 7, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjuryDec 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM BELGIUM REPORTS AN EVENT AS FOLLOWS: SUBJECT LEU-081 AE1: POSTOPERATIVE ADVERSE EVENT: "FRACTURE-RELATED INFECTION (FRI)" IS THE AE RELATED TO THE TIBIAL FRACTURE AND/OR TREATMENT OF TIBIAL FRACTURE? "YES" IS THE AE RELATED TO THE DEVICE? ¿YES" DPS IMPLANT WAS USED. THIS REPORT IS FOR A TIBIAL NAIL-ADVANCED / 8MM 285MM / STERILE. THIS IS REPORT 1 OF 10 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18282715 ↗
• MalfunctionJun 21, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING A PROCEDURE FOR ORIF WITH A TNA FOR THE FRACTURE OF THE DIAPHYSEAL TIBIA, THE SURGEON INSERTED THE NAIL TO THE OPTIMAL DEPTH TO BEGIN DRILLING FOR A PROXIMAL LOCKING SCREW. THE DRILL BIT INTERFERED WITH THE NAIL HOLE WHILE DRILLING, IN BOTH ML HOLES. AFTER INVESTIGATING, IT WAS DISCOVERED THAT THE INTERFERENCE OCCURRED BEHIND THE HOLE, SO THE SURGEON DRILLED AGAIN WHILE ADJUSTING BY HAND. THE DRILL BIT INTERFERED WITH THE NAIL HOLE, BUT THE SURGEON WAS ABLE TO DRILL AND INSERT SCREWS. WHILE REMOVING THE INSERTION HANDLE, THE CONNECTING SCREW CAME OFF WITH A RASPING SOUND AND THE SURGEON CONCLUDED THAT NAIL DEFLECTION HAD OCCURRED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH LESS THAN A 30 MINUTES DELAY. THIS REPORT IS FOR A TIBIAL NAIL-ADVANCED / 8MM 285MM / STERILE. THIS IS REPORT 1 OF 2 FOR (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14758462 ↗

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 A
• 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 A