NA 04.045.076Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982293015), received between Sep 27, 2021 and Dec 12, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Migration” (5 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2023Migration; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE DISTAL INTERLOCK SCREW BACKED OUT OF AN RFNA STANDARD BEND NAIL. A REVISION PROCEDURE WAS COMPLETED ON AN UNKNOWN DATE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A LOCKING SCREW FOR IM NAIL Ø 5MM/ 76MM/ XL25. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18311605 ↗
• InjuryFeb 21, 2023Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO REPAIR A PERIPROSTHETIC DISTAL FEMUR FRACTURE WITH A RETROGRADE FEMORAL NAIL AND SCREWS ON (B)(6) 2022. PATIENT WAS BROUGHT BACK TO THE OR TO REMOVE TWO DISTAL INTERLOCKING SCREWS THAT HAD BEGUN TO BACK OUT OF THE INTRAMEDULLARY NAIL ON (B)(6) 2023. THE TWO SCREWS WERE REMOVED EASILY AND NO FURTHER INTERVENTION WAS REQUIRED. THERE WAS PATIENT CONSEQUENCES DUE TO PAIN. THIS REPORT IS FOR ONE (1) LOCKING SCREW FOR IM NAIL 5/ 76/ XL25. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 16409416 ↗
• InjurySep 16, 2022Migration; Migration

  IT WAS REPORTED THAT THE DISTAL 5.0MM INTERLOCKING SCREW BACKED OUT ON AN UNKNOWN DATE. ON (B)(6) 2022, THE SURGEON PERFORMED AN IM NAIL FEMUR FIXATION USING THE NEW RFNA SYSTEM. THE PATIENT CAME FOR A RECENT FOLLOW UP VISIT AND EVERYTHING LOOKED TO BE GOING ACCORDING TO PLAN. WITHIN A WEEK OR SO AFTER THE FOLLOW UP VISIT, THE PATIENT CALLED WITH COMPLAINTS OF LATERAL KNEE PAIN. UNDER NEW IMAGING, IT WAS DETERMINED THE DISTAL LATERAL TO MEDIAL INTERLOCKING SCREW WAS BACKED OUT. THIS REPORT INVOLVES ONE LOCKING SCREW FOR IM NAIL Ø 5MM/ 76MM/ XL25 . THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 15441315 ↗
• InjuryMar 17, 2022Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT THE 76MM 5.0 LOCKING SCREW WAS THE MOST DISTAL TRANSVERSE LOCKING SCREW THAT APPEARED TO BE BACKED OUT 3-4CM, PRESSING AGAINST THE SKIN. THE SCREW WAS REMOVED, NO ADDITIONAL IMPLANTS. THERE WERE NO PATIENT CONSEQUENCES. THIS COMPLAINTS INVOLVES ONE (1) DEVICE LOCKING SCREW FOR IM NAIL 5/ 76/ XL25. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13800562 ↗
• InjurySep 27, 2021Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT REMOVAL SURGERY DUE TO THE LOCKING SCREW BACKED OUT OF THE DISTAL HOLE OF THE RFNA AFTER 2 MONTHS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES. CONCOMITANT DEVICE REPORTED: UNK - NAILS: RAFN: (PART# UNKNOWN; LOT# UNKNOWN; QUALITY:1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) LOCKING SCREW FOR IM NAIL 5/ 76/ XL25. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12537337 ↗

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 Adva
• 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