NA 04.233.036SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982289148), received between Jul 22, 2022 and Nov 5, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). POST MARKET STUDIES: CLINICAL ADVERSE EVENT RECEIVED FOR NON-UNION. DATE OF IMPLANT: ON (B)(6) 2022, DATE OF REVISION: ON (B)(6) 2023, DEVICE LOCATION: LEFT. TREATMENT/IMPACT: SURGICAL INTERVENTION AT THE FRACTURE SITE.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 23479044 ↗
• InjuryJul 24, 2023Break; Break

  HOLD FOR KR 7/25. IT WAS REPORTED THAT ON (B)(6) 2023, PATIENT WAS TREATED WITH A 10X360MM RFNA FOR A FRACTURE ABOVE A 4.5 VA-LCP CURVED CONDYLAR PLATE FROM A PREVIOUS SURGERY APPROXIMATELY SIX MONTHS AGO. PATIENT SHOWED SIGNS OF HEALING MEDIALLY WHEN PATIENT HEARD A POP. THE NAIL BROKE AT THE FRACTURE ZONE. AFFECTED HARDWARE WAS REMOVED AND THE PATIENT WAS REVISED TO A LARGER DIAMETER RFNA WITH BONE GRAFT OBTAINED FROM RIA2. NON-UNION RESULTING IN BROKEN NAIL WHICH WAS REMOVED ON (B)(6) 2023. SURGEON REMOVED BROKEN HARDWARE AND REVISED WITH BONE GRAFTING. THERE WAS PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) RFNA / 10MM / 360MM STANDARD BEND / STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17380659 ↗
• InjuryJun 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY ID: DEPUY - DST202103 SUBJECT ID: 00164-028 ADVERSE EVENT TERM: NONUNION IS THIS A WORSENING OF AN EXISTING EVENT? NO SITE AWARENESS DATE: (B)(6) 2023 TYPE OF EVENT: LOCAL/FRACTURE SITE SIDE: LEFT IS THE ADVERSE EVENT SERIOUS? YES SEVERITY: MODERATE THIS REPORT IS FOR A RFNA / 10MM / 360MM STANDARD BEND / STERILE. THIS IS REPORT 1 OF 10 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17212961 ↗
• InjuryMay 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE WITH LEFT RETROGRADE FEMORAL NAIL ADVANCED (RFNA) TO TREAT DISTAL FEMUR FRACTURE. POSTOPERATIVELY PATIENT EXPERIENCED CLOSED FRACTURE OF LEFT FEMUR WITH NONUNION, PAIN, WOUND INFECTION WHICH RESULTED IN MEDICAL OR SURGICAL INTERVENTION. PATIENT OUTCOME IS REPORTED AS RECOVERED/RESOLVED. POST MARKET STUDIES SUBJECT ID: (B)(4). THIS REPORT IS FOR ONE (1) RFNA / 10MM / 360MM 5 DEGREE BEND / STERILE. THIS IS REPORT 1 OF 8 FOR COMPLAINT: (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain; Post Operative Wound Infection

  MAUDE report 16987144 ↗
• InjuryApr 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023 THAT THE PATIENT EXPERIENCED PAIN, NONUNION, AND WOUND INFECTION. THE WOUND INFECTION REQUIRED SURGICAL INTERVENTION. THE ADVERSE EVENT HAS BEEN REPORTED FOR SUBJECT (B)(6) FOR THE DST202103 STUDY: THE ADVERSE EVENT TERM: ACUTE LEFT ANKLE PAIN & ACUTE KNEE PAIN. SITE AWARENESS DATE: (B)(6) 2023. START DATE: (B)(6) 2023. TYPE OF EVENT: LOCAL/FRACTURE SITE. DEVICE: RFNA . THIS REPORT IS FOR ONE (1) RFNA/ 10MM/ 360MM/ STANDARD BEND/ STER THIS IS REPORT 1 OF 9 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain; Post Operative Wound Infection

  MAUDE report 16791640 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ADVERSE EVENT HAS BEEN REPORTED ON AN UNKNOWN DATE IN THE DATABASE FOR CRFS FOR THE CLINICAL STUDY DST202103 SUBJECT 0073-019. ADVERSE EVENT: NONUNION, START DATE: (B)(6) 2023, TYPE OF EVENT: LOCAL/FRACTURE SITE, CREATION DATE: (B)(6) 2023, SEVERITY: MODERATE. THIS REPORT IS FOR ONE (1) RFNA / 10MM / 360MM 5 DEGREE BEND / STERILE. THIS IS REPORT 1 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16584732 ↗
• 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 OR 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 RFNA / 10MM / 360MM 5 DEGREE BEND / STERILE. THIS IS REPORT 2 OF 7 FOR PC-001151536.

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

  MAUDE report 15089377 ↗

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-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
• 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