NA 04.045.036SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982294401), received between Oct 20, 2023 and Mar 18, 2024 — classified as 1 injury, 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, 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 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.

• MalfunctionMar 18, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE SURGEON WAS TREATED THIS PATIENT WITH FRNA GT NAIL. WHILE IMPLANTING THE FEMORAL NAIL A 3.2X400 WIRE MISSED THE HOLE THROUGH THE NAIL. THE WIRE WAS HITTING THE NAIL AT AN INCORRECT ANGLE AND UNDER XRAY IMAGING SEE THE TRAJECTORY WASN¿T THE SAME AS THE TRACER TRAJECTORY. THIS STEP IN THE SURGICAL TECHNIQUE WAS REPEATED SEVERAL TIMES TO SEE WHY THIS STEP WASN¿T WORKING. THIS CREATED AN ISSUE BECAUSE THE SECOND RECON SCREW WASN'T ABLE TO BE IMPLANTED AS IT WOULDN¿T FIT THROUGH THE NAIL. THERE WASN¿T A DELAY IN SURGERY CAUSE BY THIS EVENT. THE FRNA IMPLANT HAS TWO DIFFERENT PROXIMAL LOCKING OPTIONS. "RECON LOCKING¿ AND THE OTHER ¿STANDARD LOCKING¿. SINCE RECON LOCKING WASN¿T WORKING THE SURGEON WAS ABLE TO PREFORM ¿STANDARD LOCKING¿ . THE SURGERY WAS COMPLETED SUCCESSFULLY. NO ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT. THIS REPORT IS FOR ONE (1) LCKNG SCR FOR IM NL 5/ 36/ XL25/ SILE THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18921839 ↗
• InjuryOct 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, A BROKEN TNA NEEDED REMOVING AND RE-NAILING. THE NAIL HAD BROKEN AT THE DISTAL END. THE NAIL WAS ORIGINALLY IMPLANTED ON (B)(6) 2023, AND WAS REMOVED ON (B)(6) 2023 AND RE-NAILED WITH A 10X360MM TNA. ALL PREVIOUS NAIL ITEMS WERE REMOVED. THE REVISION PROCEDURE WAS PERFORMED BECAUSE OF THE BROKEN IMPLANT, THE FRACTURE HAD NOT HEALED. THE PATIENT HAD SIGNIFICANT DISTAL BONE LOSS AND A MASQUELET PROCEDURE WAS COMPLETED. THE PATIENT HAD BORNE WEIGHT AFTER BONE GRAFT HAD BEEN INSERTED, AND THIS IS WHEN THE NAIL BROKE. REAMINGS SENT OFF DURING THE CASE CAME BACK POSITIVE FOR INFECTION. THE REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT IS PROGRESSING WELL. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A LOCKING SCREW FOR IM NAIL Ø 5MM/ 36MM/ XL25/ STERILE. THIS IS REPORT 2 OF 7 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 17975192 ↗

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 A
• 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