NA 04.045.080Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10886982293039), received between May 26, 2021 and Sep 27, 2024 — classified as 11 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Migration” (13 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2024Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2024, IT WAS NOTIFIED BY A SURGEON THAT A DISTAL LOCKING SCREW OF AN RFNA HAD BACKED OUT FROM THE NAIL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20320483 ↗
• InjuryFeb 7, 2024Migration; Migration

  IT WAS REPORTED ON (B)(6) 2024, REVISION SURGERY OCCURRED DUE TO FEMUR ORIF RETROGRADE SCREW MIGRATION. INITIAL IMPLANT WAS APPROXIMATELY 3 MONTHS PRIOR. PATIENT WAS NOT FULLY UNITED. HARDWARE PROMINENCE CAUSING THE SKIN TO BE TENTED. PATIENT WAS REVISED TO A PLATE. BOTH INITIAL AND REVISION SURGERY HAD BEEN COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE LOCKING SCREW FOR IM NAIL 5/ 80/ XL25 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18662492 ↗
• InjuryMay 31, 2023Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2023, THE SCREW BACKED OUT OF NAIL IN PATIENT'S BONE. THIS REPORT IS FOR ONE (1) LOCKING SCREW FOR IM NAIL Ø 5MM/ 80MM/ XL25. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 17030523 ↗
• MalfunctionMay 23, 2023Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2023, THE RETROGRADE FEMORAL NAILING SYSTEM (RFNA) DISTAL SCREWS WERE BACKED OUT OF PLATE INSIDE PATIENT'S BONE. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) LOCKING SCREW FOR IM NAIL Ø 5MM/ 80MM/ XL25. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16988726 ↗
• MalfunctionMay 23, 2023Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2023, THE RETROGRADE FEMORAL NAILING SYSTEM (RFNA) DISTAL SCREWS WERE BACKED OUT OF PLATE INSIDE PATIENT'S BONE. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) LOCKING SCREW FOR IM NAIL Ø 5MM/ 80MM/ XL25. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16988721 ↗
• MalfunctionMay 23, 2023Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2023, THE RETROGRADE FEMORAL NAILING SYSTEM (RFNA) DISTAL SCREWS WERE BACKED OUT OF PLATE INSIDE PATIENT'S BONE. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) LOCKING SCREW FOR IM NAIL Ø 5MM/ 80MM/ XL25. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16988718 ↗
• MalfunctionMay 23, 2023Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2023, THE RETROGRADE FEMORAL NAILING SYSTEM (RFNA) DISTAL SCREWS WERE BACKED OUT OF PLATE INSIDE PATIENT'S BONE. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) LOCKING SCREW FOR IM NAIL Ø 5MM/ 80MM/ XL25. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16988716 ↗
• MalfunctionDec 12, 2022Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS CONTINUED OBSERVATION OF THE LOOSE SCREW DISTALLY. UNSPECIFIED PATIENT CONSEQUENCE WAS REPORTED, BUT NO MEDICAL INTERVENTION WAS PERFORMED. REPORTED COMORBIDITY ¿ PERIPROSTHETIC. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE LOCKING SCREW FOR IM NAIL Ø 5MM/ 80MM/ XL25. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15960795 ↗
• InjuryDec 12, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022, RFNA DISTAL SCREW BACK OUT OCCURRED. THERE WERE AN UNKNOWN NUMBER OF SCREWS AND LENGTH. REVISION SURGERY TO REMOVE THE HARDWARE WAS PERFORMED DUE TO PAIN, AND A LATERAL PLATE WAS ADDED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE LOCKING SCREW FOR IM NAIL Ø 5MM/ 80MM/ XL25. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 15960597 ↗
• InjuryDec 12, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022 THERE WAS RFNA DISTAL SCREW BACK OUT. REMOVAL OF HARDWARE WAS DONE DUE TO PAIN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE LOCKING SCREW FOR IM NAIL Ø 5MM/ 80MM/ XL25. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 15960564 ↗
• InjuryDec 12, 2022Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO IMPLANT PRODUCTS ON (B)(6) 2022. ON (B)(6) 2022, A REVISION SURGERY AND HARDWARE REMOVAL WAS PERFORMED DUE TO BACKOUT OF A DISTAL RFNA SCREW. THE PATIENT HAD EXPERIENCED PAIN DUE TO THE BACK OUT. THERE WAS AN UNKNOWN NUMBER OF SCREWS INVOLVED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE LOCKING SCREW FOR IM NAIL Ø 5MM/ 80MM/ XL25. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; Pain

  MAUDE report 15960089 ↗
• InjuryMar 29, 2022Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO LOOSENING AND BACKING OUT OF THE SCREW. PATIENT TAKEN TO SURGERY TO REMOVE SCREW. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE LOCKING SCREW FOR IM NAIL 5/ 80/ 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 13940943 ↗
• InjuryMar 10, 2022Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN USA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO LOOSENING AND BACKING OUT OF THE SCREW. SCREW BACKING OUT FROM RETROGRADE NAIL. PATIENT HAD SECOND OPERATION TO REPLACE THE SCREW. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES ONE(1) DEVICE LOCKING SCREW FOR IM NAIL 5/ 80/ XL25. THIS IS REPORT 1 OF 1 FOR COMPLAINT PC-(B)(4).

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

  MAUDE report 13721146 ↗
• InjuryFeb 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON REMOVED THE UNKNOWN DISTAL LOCKING SCREW AND UNKNOWN NUT FOR AN UNKNOWN REASON. THE PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS REPORT IS FOR ONE (1) UNK - SCREWS: NAIL DISTAL LOCKING THIS IS REPORT 1 OF 2 FOR PC-(B)(4).

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

  MAUDE report 13591776 ↗
• InjuryJan 7, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT WAS SEEN IN CLINIC FOR 8 WEEK FOLLOW UP FOR REPAIR OF NON UNION OF DISTAL FEMUR FRACTURE. INITIAL SURGERY DATE WAS (B)(6) 2021, WHERE A DISTAL FEMORAL LOCKING PLATE WAS REMOVED AND A RFNA 5 DEGREE NAIL WAS IMPLANTED. THE MOST DISTAL TRANSVERSE LATERAL TO MEDIAL SCREW IN THE RFNA BACKED OUT AND WAS TENTING THE SKIN. ON (B)(6) 2021 REMOVAL OF HARDWARE WAS COMPLETED TO TAKE OUT THE SCREW THAT BACKED OUT OF THE RFNA NAIL. THE REMAINING HARDWARE WAS INTACT AND LEFT IN PLACE, WITH NO FURTHER MEDICAL INTERVENTION PLANNED AT THIS TIME. THIS REPORT IS FOR ONE (1) LOCKING SCREW FOR IM NAIL Ø 5MM/ 80MM/ XL25. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 13191889 ↗
• InjuryJun 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A REVISION DUE TO LOSS OF FIXATION. WE WERE MADE AWARE OF A REVISION OF IMPLANTS THAT'S SHOULD BEEN IMPLANTED ON (B)(6) 2021. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY REPORTED. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR (1)LOCKING SCREW FOR IM NAIL 5/ 80/ XL25 THIS REPORT IS 6 OF 7 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12021129 ↗
• InjuryMay 26, 2021Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2021, A PATIENT UNDERWENT A SURGERY FOR THE PERIPROSTHETIC DISTAL FEMUR FRACTURE. DURING THE PROCEDURE, A RETROGRADE FEMORAL NAIL ADVANCED WAS PLACED AND 5MM XL25 LOCKING SCREWS WERE INSERTED TO THE NAIL. ON (B)(6) 2021 ONE OF THE DISTAL TRANSVERSE SCREWS BACKED OUT OF THE NAIL REQUIRING REVISION SURGERY WHICH INCLUDED THE REMOVAL OF THE PROMINENT SCREW, INSERTION OF A NEW XL 25 SCREW WITH WASHER AND CONDYLAR NUT ON THE MEDIAL SIDE. SURGERY WENT AS PLANNED AND WITHOUT INCIDENT. THIS REPORT IS FOR ONE (1) LOCKING SCREW FOR IM NAIL Ø 5MM/ 80MM/ 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 11886298 ↗

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-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