NA 04.045.034Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982292742), received between Jul 22, 2022 and Oct 11, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionOct 11, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT HAD A BROKEN IMPLANT FAILURE. A NON-UNION OCCURRED AFTER 8 MONTHS WITH TFNA. THE NAIL WAS REPORTED TO HAVE BROKEN AT THE JUNCTURE OF THE HELICAL BLADE. THE REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A LOCKING SCREW FOR IM NAIL Ø 5MM/ 34MM/ XL25. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17914766 ↗
• InjuryJul 22, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022, A PATIENT SUSTAINED AN OPEN DISTAL FEMUR FRACTURE FROM A GUNSHOT WOUND. THE FRACTURE WAS TREATED WITH A RETROGRADE FEMORAL NAIL AND INTERLOCKING SCREWS. ON (B)(6) 2022, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH A SUSPECTED INFECTION. X-RAY IMAGES SHOWED DELAYED UNION AND THE MIGRATION OF ONE OBLIQUE DISTAL INTERLOCKING SCREW. ON (B)(6) 2022, PATIENT WAS BROUGHT TO THE OPERATING ROOM FOR IRRIGATION AND DEBRIDEMENT AND REMOVAL OF MIGRATED SCREW. THE SCREW LOW PROF LCKNG SCR 5.0 / L 64 / XL25 WAS REMOVED AND REPLACED WITH SCREW LOCKING SCREW FOR IM NAIL 5/ 90/ XL25. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A LOCKING SCREW FOR IM NAIL Ø 5MM/ 34MM/ XL25. THIS IS REPORT 4 OF 7 FOR (B)(4).

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

  MAUDE report 15089476 ↗

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