NA 04.233.242SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982290908), received between Apr 22, 2021 and Nov 14, 2024 — classified as 4 injuries, 1 malfunction.

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

• MalfunctionNov 14, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN INTRAMEDULLARY NAILING OF A FEMUR ON (B)(6) 2024, THE PATIENT WAS SUPINE ON A FLAT TOP BED AND THE OPERATIVE LEG WAS ON A FOAM BUMP TO ELEVATE THE LEG. STANDARD INCISION AND GUIDE WIRE WAS USED TO FIND THE ENTRY POINT IN THE DISTAL FEMUR. ONCE THE ENTRY POINT WAS FOUND THE SURGEON USED THE 11.2MM OPENING REAMER AND A 2.5MM BALL TIP GUIDE WIRE WAS PLACED IN THE OPERATIVE CANAL. INTRAMEDULLARY CANAL WAS REAMED IN STANDARD FASHION WITH SYNTHES FLEXIBLE REAMERS AND THE BALL TIP WAS MEASURED FOR LENGTH. SURGEON REAMED TO A 13.5MM REAMER AND A 12 X 420 RFNA NAIL WAS CHOSEN. NAIL WAS ATTACHED TO THE INSERTION HANDLE WITH CONNECTING SCREW. NAIL WAS INSERTED INTO FEMUR AND A MALLET WAS UTILIZED TO DRIVE NAIL INTO THE CANAL. AFTER NAIL WAS ROUGHLY 75% INSERTED, AN X-RAY WAS UTILIZED TO CHECK FRACTURE SITE. SURGEON WAS NOT HAPPY WITH REDUCTION AND ATTEMPTED TO REMOVE THE RETROGRADE NAIL. UPON BACKSLAPPING THE NAIL, THE CONNECTING SCREW/DRIVING CAP BECAME LOSE AND SURGEON RETIGHTENED THE CONNECTING SCREW WITH THE 11MM WRENCH. NAIL WAS REMOVED AND FRACTURE WAS MANUALLY REDUCED AND THE NAIL WAS RE-INSERTED IN THE FEMUR. UPON IMPACTING THE DRIVING CAP ON REINSERTION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20682684 ↗
• InjuryJul 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6)2022 AFTER A MECHANICAL FALL FROM STANDING, IMAGING SHOWED RIGHT DISTAL FEMUR FRACTURE AND LEFT PROXIMAL HUMERUS FRACTURE. ON (B)(6)2022 THE PATIENT UNDERWENT IMN OF RIGHT FEMUR. ORIF OF LEFT HUMERUS FRACTURE ON (B)(6)2022. HE WAS DISCHARGED FOR ACUTE REHAB ON JUNE 01, 2022. ON (B)(6)2023 THE PATIENT WAS ADMITTED FOR RIGHT FEMUR NONUNION REVISION, WITH WORSENING RIGHT THIGH PAIN AND IMPAIRED MOBILITY. THE PATIENT WAS FOR ANTIBIOTIC MANAGEMENT OF RIGHT FEMORAL OSTEOMYELITIS.

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

  MAUDE report 17343776 ↗
• InjuryJul 29, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE NAIL BROKE JUST ABOVE THE JUNCTURE WHERE MEDIAL/LATERAL OBLIQUE SCREW HEADS SIT IN DISTAL ASPECT OF NAIL. IT IS UNKNOWN WHEN THE ISSUE WAS OBSERVED. PATIENT CONSEQUENCES ARE UNKNOWN. THIS REPORT IS FOR ONE (1) RFNA/ 12MM/ 420MM/ STANDARD BEND/ STER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15129110 ↗
• 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) RFNA / 12 / 420 5 DEG BEND / STERILE. THIS REPORT IS 1 OF 7 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12021110 ↗
• InjuryApr 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE RIGHT FEMUR ON (B)(6) 2021, THE MORE STANDARD START POINT FOR A NEW RETROGRADE FEMORAL NAIL (RFN) CAUSED A MAL REDUCTION OF FEMUR FRACTURE AS THE NAIL PASSED THE FRACTURE SITE; CHANGED TO ANTEGRADE FEMORAL NAIL AND THE PROBLEM WENT AWAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A TEN (10) MINUTE DELAY. THIS REPORT IS FOR A RFNA NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Physical Asymmetry

  MAUDE report 11706681 ↗

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