NA 03.233.004Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982288240), received between Aug 22, 2024 and Aug 21, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (9 reports).

2 other recalls cover devices cleared under the same FDA submission (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. 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.

• MalfunctionAug 21, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THE INSTRUMENT CAN NO LONGER BE GUIDED THROUGH THE INSERTION HANDLE TO LOCK THE NAIL. EVENT WAS NOTED AS PRE-OP, DURING PRODUCT/SYSTEM INSTRUCTION. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22860696 ↗
• MalfunctionNov 19, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN RFNA PROCEDURE WHILE ENTRY REAMING, THE SLEEVE BENT FROM PRESSURE OF THE SLEEVE AND DULL NESS OF THE REAMER. WHILE INSERTING THE LAW, OBLIQUE SCREWS MISSED THE NAILS. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20723288 ↗
• MalfunctionAug 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING A PROFESSIONAL EDUCATION EVENT (LOWER LIMB MASTERS COURSE) WITH HUMAN ANATOMIC SPECIMENS IN BANGKOK, THERE WAS SOME DIFFICULTY WHEN ASSEMBLING THE RFNA CONNECTION BOLT INTO THE RFNA INSERTION HANDLE. THIS DIFFICULTY WAS ENCOUNTERED ON THREE OF THE 20 WORKSHOP TABLES. THE TECHNICIAN IN THE LAB WAS ABLE TO ASSEMBLE THE PARTS AFTER 10 MINUTES, WHICH REQUIRED SOME FORCE. THERE WAS NO PATIENT HARM. THIS REPORT INVOLVES ONE NAIL ASSEMBLY INSTRUMENT. THIS IS REPORT 5 OF 10 FOR (B)(4). THIS REPORT IS RELATED T(B)(4), WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20037878 ↗
• MalfunctionAug 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON JUNE 16, 2024, DURING A PROFESSIONAL EDUCATION EVENT (LOWER LIMB MASTERS COURSE) WITH HUMAN ANATOMIC SPECIMENS IN BANGKOK, THERE WAS SOME DIFFICULTY WHEN ASSEMBLING THE RFNA CONNECTION BOLT INTO THE RFNA INSERTION HANDLE. THIS DIFFICULTY WAS ENCOUNTERED ON THREE OF THE 20 WORKSHOP TABLES. THE TECHNICIAN IN THE LAB WAS ABLE TO ASSEMBLE THE PARTS AFTER 10 MINUTES, WHICH REQUIRED SOME FORCE. THERE WAS NO PATIENT HARM. THIS REPORT INVOLVES ONE NAIL ASSEMBLY INSTRUMENT. THIS IS REPORT 6 OF 10 FOR (B)(4). THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20037312 ↗
• MalfunctionAug 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON JUNE 16, 2024, DURING A PROFESSIONAL EDUCATION EVENT (LOWER LIMB MASTERS COURSE) WITH HUMAN ANATOMIC SPECIMENS IN BANGKOK, THERE WAS SOME DIFFICULTY WHEN ASSEMBLING THE RFNA CONNECTION BOLT INTO THE RFNA INSERTION HANDLE. THIS DIFFICULTY WAS ENCOUNTERED ON THREE OF THE 20 WORKSHOP TABLES. THE TECHNICIAN IN THE LAB WAS ABLE TO ASSEMBLE THE PARTS AFTER 10 MINUTES, WHICH REQUIRED SOME FORCE. THERE WAS NO PATIENT HARM. THIS REPORT INVOLVES ONE NAIL ASSEMBLY INSTRUMENT. THIS IS REPORT 8 OF 10 FOR (B)(4). THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20037191 ↗
• MalfunctionAug 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON JUNE 16, 2024, DURING A PROFESSIONAL EDUCATION EVENT (LOWER LIMB MASTERS COURSE) WITH HUMAN ANATOMIC SPECIMENS IN BANGKOK, THERE WAS SOME DIFFICULTY WHEN ASSEMBLING THE RFNA CONNECTION BOLT INTO THE RFNA INSERTION HANDLE. THIS DIFFICULTY WAS ENCOUNTERED ON THREE OF THE 20 WORKSHOP TABLES. THE TECHNICIAN IN THE LAB WAS ABLE TO ASSEMBLE THE PARTS AFTER 10 MINUTES, WHICH REQUIRED SOME FORCE. THERE WAS NO PATIENT HARM. THIS REPORT INVOLVES ONE NAIL ASSEMBLY INSTRUMENT. THIS IS REPORT 7 OF 10 FOR (B)(4). THIS REPORT IS RELATED TO (B)(4) AND (B)(4), WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20036151 ↗
• MalfunctionAug 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING A PROFESSIONAL EDUCATION EVENT (LOWER LIMB MASTERS COURSE) WITH HUMAN ANATOMIC SPECIMENS IN BANGKOK, THERE WAS SOME DIFFICULTY WHEN ASSEMBLING THE RFNA CONNECTION BOLT INTO THE RFNA INSERTION HANDLE. THIS DIFFICULTY WAS ENCOUNTERED ON THREE OF THE 20 WORKSHOP TABLES. THE TECHNICIAN IN THE LAB WAS ABLE TO ASSEMBLE THE PARTS AFTER 10 MINUTES, WHICH REQUIRED SOME FORCE. THERE WAS NO PATIENT HARM. THIS REPORT INVOLVES ONE NAIL ASSEMBLY INSTRUMENT. THIS IS REPORT 9 OF 10 FOR (B)(4). THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20034985 ↗
• MalfunctionAug 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING A PROFESSIONAL EDUCATION EVENT (LOWER LIMB MASTERS COURSE) WITH HUMAN ANATOMIC SPECIMENS IN BANGKOK, THERE WAS SOME DIFFICULTY WHEN ASSEMBLING THE RFNA CONNECTION BOLT INTO THE RFNA INSERTION HANDLE. THIS DIFFICULTY WAS ENCOUNTERED ON THREE OF THE 20 WORKSHOP TABLES. THE TECHNICIAN IN THE LAB WAS ABLE TO ASSEMBLE THE PARTS AFTER 10 MINUTES, WHICH REQUIRED SOME FORCE. THERE WAS NO PATIENT HARM. THIS REPORT INVOLVES ONE NAIL ASSEMBLY INSTRUMENT. THIS IS REPORT 10 OF 10 FOR (B)(4(. THIS REPORT IS RELATED TO , (B)(4) WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20034207 ↗
• MalfunctionAug 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING AN APAC PROFESSIONAL EDUCATION EVENT (LOWER LIMB MASTERS COURSE) WITH HUMAN ANATOMIC SPECIMENS THERE WAS SOME DIFFICULTY ENCOUNTERED WHEN ASSEMBLING THE RFNA CONNECTION BOLT INTO THE RFNA INSERTION HANDLE. THIS CHALLENGE WAS ENCOUNTERED ON THREE (3) OF THE 20 WORKSHOP TABLES. TECHNICIAN IN THE LAB AT THE TIME WAS ABLE TO ASSEMBLE THE PARTS AFTER 10 MINUTES WHICH REQUIRED SOME FORCE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) NAIL ASSEMBLY INSTRUMENT. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS PRODUCT COMPLAINT IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20032496 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under 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 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