NA 04.233.134SRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982290656), received between Feb 17, 2023 and Apr 30, 2025 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K201346, K233696); 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2025Migration; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DISTAL LOCKING BOLT IN A DEPUY SYNTHES RFNA NAIL HAD UNTHREADED ITSELF FROM THE NAIL POSTOPERATIVELY, REQUIRING A REVISION SURGERY TO REPLACE THE SCREW. PATIENT HAD INFLAMMATION OF THE LATERAL KNEE AND REVISION SURGERY WAS REQUIRED. IT WAS FURTHER REPORTED THAT THERE WAS ALLEGATION AGAINST THE POLYMER INLAY OF THE RFNA NAIL WHICH HAS APPEARED MORE SUSCEPTIBLE TO SCREW BACK OUT THAN OTHER NAILS. THIS COMPLAINT (B)(4) IS RELATED TO (B)(4) WHICH CAPTURES REVISION SURGERY FROM (B)(6) 2025 WHICH FAILED AGAIN AS THE SCREW, WASHER, AND LOCKING NUT HAVE BECOME LOOSE AND BEGUN TO BACK OUT.

  Patient problems: Inflammation

  MAUDE report 21936263 ↗
• MalfunctionDec 18, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS A SURGICAL DELAY ESTIMATED TO BE 10 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 20967775 ↗
• MalfunctionDec 18, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS A SURGICAL DELAY ESTIMATED TO BE 10 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 20967663 ↗
• InjuryJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON REMOVED A RETROGRADE NAIL ON (B)(6) 2024 DUE TO A SUSPECTED INFECTION. THE REVISION WAS COMPLETED SUCCESSFULLY. THE DATE OF INITIAL IMPLANTATION IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE RFNA / 11MM / 340MM STANDARD BEND / STERILE THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 19722544 ↗
• InjuryJul 11, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT THE SURGERY FOR DOUBLE FRACTURE OF THE FEMORAL SUBTROCHANTERIC AND SUPRACONDYLAR WITH RFNA. AFTER THE SURGERY, THE NAIL FRACTURE DAMAGE WAS OBSERVED AT THE TRANSVERSE STOP HOLE DUE TO PSEUDARTHROSIS AT THE PROXIMAL FRACTURE SITE. IT IS POSSIBLE THAT THE PROXIMAL FIXATION WAS INADEQUATE DUE TO THE CRUSHED SUBCONDYLAR AREA. ON (B)(6) 2024, THE NAIL IN QUESTION WAS REMOVED AND REPLACED WITH AN ARTIFICIAL HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE PATIENT STATUS/OUTCOME WAS REPORTED AS STABLE. THIS REPORT IS FOR AN RFNA NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 19719780 ↗
• InjuryJul 17, 2023Break; Break

  IT WAS REPORTED THAT AN RFNA BROKE AFTER A MASQUELET PROCEDURE. REVISION SURGERY OCCURRED ON (B)(6)2023. THE SURGEON STATED THAT HE USES A MASQUELET THAT MIGHT HAVE BEEN OUTSIDE THE INDICATED BOUNDS OF THE PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE RFNA / 11MM / 340MM STANDARD BEND / STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17333453 ↗
• InjuryJun 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SUSTAINED AN INJURY ON (B)(6) 2023. A LEFT SIDE RFNA WAS IMPLANTED ON (B)(6) 2023 FOR TREATMENT. SIX LOCKING SCREWS WERE USED FOR FIXATION. AT THE PATIENT¿S THREE MONTH HEALING/UNION ASSESSMENT ON (B)(6) 2023, IT WAS NOTED THAT UNION HAD NOT YET BEEN ACHIEVED. THIS REPORT INVOLVES ONE RFNA / 11MM / 340MM STANDARD BEND / STERILE. THIS IS REPORT 7 OF 8 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17183517 ↗
• InjuryFeb 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT CRF CASEBOOK FOR SUBJECT: (B)(4). THE CRFS INCLUDE ADVERSE EVENT NONUNION OF RIGHT DISTAL FEMUR AND REVISION DETAILS FORM. ADVERSE EVENT TERM: NONUNION OF RIGHT DISTAL FEMUR. SITE AWARENESS DATE: 25 JAN 2023. START DATE: ON (B)(6) 2023. SIDE: RIGHT. DEVICE: RFNA. RELATIONSHIP TO STUDY DEVICE: NOT RELATED. RELATIONSHIP TO STUDY PROCEDURE: NOT RELATED. THIS REPORT IS FOR A RFNA / 11MM / 340MM 5 DEGREE BEND / STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16436297 ↗
• InjuryFeb 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NEW ADVERSE EVENT REPORTED FOR SUBJECT (B)(4). ADVERSE EVENT TERM: NON UNION. SITE AWARENESS DATE: 24 JANUARY 2023. START DATE: 24 JANUARY 2023. TYPE OF EVENT: LOCAL/FRACTURE SITE. DEVICE: RFNA. SERIOUS: YES. RELATIONSHIP TO STUDY DEVICE: POSSIBLE. RELATIONSHIP TO PRIMARY STUDY PROCEDURE: POSSIBLE. THIS REPORT IS FOR A RFNA/11MM/340MM 5 DEGREE BEND/STERILE. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16400098 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201346, K233696. 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