NA 04.233.236SRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982290878), received between Dec 28, 2021 and Oct 27, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Migration” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryOct 27, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT REQUIRED A RE-OPERATION DUE TO MOST DISTAL LOCKING SCREW BACKING OUT IN THE RFNA WITH PEEK INLAY.

  Patient problems: Pain

  MAUDE report 23390155 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO IMPLANT THE DEVICES ON (B)(6) 2024. POSTOPERATIVELY, THE PATIENT EXPERIENCED WOUND DEHISCENCE, WHICH REQUIRED SURGICAL INTERVENTION AT THE FRACTURE SITE. THIS REPORT INVOLVES ONE RFNA / 12MM / 360MM STANDARD BEND / STERILE. THIS IS REPORT 1 OF 10 FOR (B)(4). THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURES ADDITIONAL IMPLANTS RELATED TO THE EVENT.

  Patient problems: Wound Dehiscence

  MAUDE report 19948963 ↗
• InjuryJul 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024 PATIENT WAS BROUGHT INTO SURGERY BY SURGEON FOR A LOOSENING OF DISTAL INTERLOCKING SCREWS IN A SYNTHES RFNA FEMORAL NAIL. THE IMPLANT WAS INITIALLY PLACED BY SURGEON ON (B)(6) 2024 AT THE SAME FACILITY. AT SOME POINT AFTER THAT DATE THE PATIENTS NURSING HOME NOTICED PROMINENT HARDWARE AT THE SKIN. THE PATIENT WAS BROUGHT TO THE HOSPITAL FOR REVISION SURGERY ON (B)(6) 2024 . THERE WAS AN INFECTION. THERE WAS NO SURGICAL DELAY. THIS REPORT INVOLVES ONE (1) RFNA / 12MM / 360MM STANDARD BEND / STERILE. THIS IS REPORT 5 OF 6 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 19806174 ↗
• InjuryNov 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). ADVERSE EVENT TERM: SCREW BACK OUT ASSOCIATED WITH INCREASED DISCOMFORT AND SWELLING. IS THIS A WORSENING OF AN EXISTING EVENT? YES. CREATION DATE: (B)(6) 2023. SITE AWARENESS DATE: 23-10-2023. TYPE OF EVENT: LOCAL/FRACTURE SITE. DEVICE: RFNA. THIS REPORT IS FOR AN RFNA / 12MM / 360MM STANDARD BEND / STERILE. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: Discomfort; Nonunion/Delayed-union Bone Fracture; Pain; Swelling/ Edema

  MAUDE report 18132138 ↗
• InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY ID: DEPUY - (B)(6) SUBJECT ID: (B)(6) ADVERSE EVENT TERM: INTRACTABLE BACK PAIN CREATION DATE: (B)(6) 2023 IS THIS A WORSENING OF AN EXISTING EVENT? NO TYPE OF EVENT: SYSTEMIC IS THE ADVERSE EVENT SERIOUS? YES THIS REPORT IS FOR AN RFNA / 12MM / 360MM STANDARD BEND / STERILE. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 17365569 ↗
• InjuryMay 1, 2023No Apparent Adverse Event; No Apparent Adverse Event

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, A REVISION PROCEDURE WAS PERFORMED TO RE-INSERT A SCREW THAT HAD BACKED OUT OF A RFNA NAIL. X-RAYS HAD SHOWN THAT THE MEDIAL OBLIQUE SCREW BACKED OUT OF THE RFNA NAIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN RFNA / 12MM / 360MM 5 DEGREE BEND / STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16845271 ↗
• InjuryFeb 9, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6), 2021 THE PATIENT UNDERWENT AN INITIAL SURGERY WHERE AN 85MM ANS 5.0MM LOCKING SCREW WAS INSERTED UNDER POWER INTO THE DISTAL MOST SCREW HOLE OF A 12MM X 360MM 5 DEGREE BEND RETROGRADE FEMORAL NAIL ADVANCED IN A LATERAL-TO-MEDIAL FASHION. POSTOPERATIVELY ON (B)(6) 2021 IT WAS DISCOVERED THAT THE SCREW DESCRIBED ABOVE HAD BACKED OUT LATERALLY FROM THE NAIL SIGNIFICANTLY. REVISION SURGERY WAS REQUIRED DUE TO A NON-UNION OF THE FEMUR AND WAS PERFORMED ON (B)(6) 2022 WHEN THE SCREW WAS EXPLANTED AND MORE BLOCKING SCREWS WERE INSERTED. THE PATIENT WILL CONTINUE TO BE FOLLOWED BY THE SURGEONS CLINIC. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) RFNA / 12MM / 360MM 5 DEGREE BEND / STERILE THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 13502117 ↗
• InjuryDec 28, 2021Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A HARDWARE REMOVAL OF NAIL (ADVANCED RETROGRADE FEMORAL NAIL). TWO(2) SCREWS BACKED OUT OF THIS NAIL. THE 60MM SCREW AND 70 MM SCREW WAS REMOVED FROM THE PATIENT. IT WAS UNKNOWN IF THE REMOVAL SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME IS UNKNOWN. THE ORIGINAL IMPLANT DATE WAS ON (B)(6) THIS YEAR, 2021. CONCOMITANT DEVICE REPORTED: UNK, END CAPS: RAFN (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1) .UNK, SCREWS: RAFN (PART#: UNKNOWN; LOT#: UNKNOWN, QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES THREE(3) DEVICES. THIS REPORT IS FOR (1) RFNA / 12MM / 360MM 5 DEGREE BEND / STERILE. THIS REPORT IS 1 OF 3 FOR (B)(4).

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

  MAUDE report 13100189 ↗

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