NA 03.043.025Recalls & reported problems

Summary

The FDA's MAUDE database contains 142 adverse event reports that list this exact device (DI 10886982297242), received between Feb 17, 2022 and Sep 28, 2026 — classified as 142 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (133 reports).

2 other recalls cover devices cleared under the same FDA submission (K201336); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 142 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Device-Device Incompatibility

  It was reported that the connecting screw was found at sterilisation to have Guide Wire with Stop, Ø 3.2 mm was stuck inside. There was no patient harm or surgical delay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918544 ↗
• MalfunctionJun 9, 2026Device-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN DATE, DURING THE PROCEDURE, THE DRILL BIT HIT THE TIBIAL NAIL TWICE WHEN DRILLING TWO DIFFERENT HOLES. AT THE END OF THE PROCEDURE THE CONNECTING SCREW WOULD NOT COME OFF. THERE WAS 20 MINUTES OF DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25445090 ↗
• MalfunctionJun 9, 2026Device-Device Incompatibility; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT DURING ROUTINE MEDICAL DEVICE REPROCESSING, STAFF NOTICED THE THREADS WERE STRIPPED AND THE CANNULATED CONNECTING SCREW WAS BENT OUT OF SHAPE AND COULD NOT SLIDE INTO THE INSERTION HANDLE. THEY ALSO NOTICED THE BLACK DEPTH GAUGE WIRE WAS LOOSE UNABLE TO ACCURATELY MEASURE SCREW LENGTH. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25444963 ↗
• MalfunctionMay 19, 2026Device-Device Incompatibility; Illegible Information

  IT WAS REPORTED THAT CONNECSCR CANN LONG AND EXTRACTSCR F/TIB+FEM NAILS WERE ASSOCIATED WITH POST-OPERATIVE DEVICE ISSUES. TWO CONNECTING SCREWS BECAME UNUSABLE AS THEY DID NOT ATTACH PROPERLY TO THE T HANDLE SCREWDRIVER, AND ONE EXTRACTION SCREW WOULD NOT HOLD INTO THE NAIL BEING REMOVED DUE TO AN ISSUE WITH THE THREADS. THERE WAS NO IMPACT OR CONSEQUENCE TO THE PATIENT, AND NO PATIENT INVOLVEMENT OR OBSERVABLE CLINICAL SYMPTOMS WERE IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25217301 ↗
• MalfunctionMay 19, 2026Device-Device Incompatibility; Illegible Information

  IT WAS REPORTED THAT CONNECSCR CANN LONG AND EXTRACTSCR F/TIB+FEM NAILS WERE ASSOCIATED WITH POST-OPERATIVE DEVICE ISSUES. TWO CONNECTING SCREWS BECAME UNUSABLE AS THEY DID NOT ATTACH PROPERLY TO THE T HANDLE SCREWDRIVER, AND ONE EXTRACTION SCREW WOULD NOT HOLD INTO THE NAIL BEING REMOVED DUE TO AN ISSUE WITH THE THREADS. THERE WAS NO IMPACT OR CONSEQUENCE TO THE PATIENT, AND NO PATIENT INVOLVEMENT OR OBSERVABLE CLINICAL SYMPTOMS WERE IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25217201 ↗
• MalfunctionMar 30, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THERE HAVE BEEN SEVERAL ISSUES WITH CONNECTING SCREWS NOT ALLOWING THE SURGEONS TO DO PROXIMAL SCREWS WITH A DRILL BIT. THEY HAVE DISPOSED OF THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24713494 ↗
• MalfunctionMar 24, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE WITH TIBIAL NAIL ADVANCED (TNA). AFTER INSERTION OF THE NAIL USING A SUPRAPATELLAR APPROACH AND INSTRUMENTATION, WHICH REQUIRED SOME HAMMERING USING THE DRIVING CAP, AND WHILE ATTEMPTING TO REMOVE THE THE NAIL HANDLE BY UNLOCKING THE NAIL CONNECTING SCREW, IT WAS VERY HARD TO UNLOCK, VERY HEAVY MOVING, AND REQUIRED LOT OF OVER-TORQUE, MAKING A LOUD SQUEAKING NOISE BECAUSE OF THE FRICTION. NO FRAGMENTS WERE GENERATED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24680352 ↗
• MalfunctionFeb 20, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON WAS UNABLE TO LOCK THE NAIL PROXIMALLY USING THE AIMING ARM; TARGETED TOO POSTERIOR TO THE MOST DISTAL HOLE PROXIMALLY. THE DOCTOR HAD TO LOCK FREE HAND. THE CASE WAS USING THE TNA SYSTEM SUPRAPATELLAR APPROACH. THERE WAS A FORTY-FIVE MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24400386 ↗
• MalfunctionFeb 6, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT CONNECSCR CANN LONG WAS INVOLVED IN AN INTRAOPERATIVE EVENT DURING AN ORTHOPEDIC PROCEDURE. THE REPORTED FAILURE WAS THE INABILITY TO LOCK THE NAIL PROXIMALLY USING THE AIMING ARM DURING THREE SEPARATE CASES WITH THE NEW TNA SYSTEM SUPRAPATELLAR APPROACH, RESULTING IN SURGERIES THAT LASTED AT LEAST 45 MINUTES LONGER THAN ANTICIPATED. ALL CASES REQUIRED SURGEONS TO LOCK FREE HAND DUE TO TARGETING TOO POSTERIOR TO THE MOST DISTAL HOLE PROXIMALLY. THE PATIENT CONSEQUENCE WAS EXTENDED TIME ON THE OPERATING TABLE, WITH NO ADDITIONAL CLINICAL SYMPTOMS OR COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277795 ↗
• MalfunctionFeb 6, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT CONNECSCR CANN LONG WAS INVOLVED IN AN EVENT DURING AN ORTHOPEDIC PROCEDURE. THE REPORTED FAILURE WAS AN INABILITY TO LOCK THE NAIL PROXIMALLY USING THE AIMING ARM, RESULTING IN ALL CASES TARGETING TOO POSTERIOR TO THE MOST DISTAL HOLE. SURGEONS HAD TO LOCK FREE HAND, WHICH LED TO A SURGERY DELAY OF APPROXIMATELY 45 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, AND NO FRAGMENTS WERE GENERATED. THE PATIENT CONSEQUENCE WAS A LONGER TIME ON THE TABLE, WITH NO ADDITIONAL CLINICAL OUTCOME OR INTERVENTION DESCRIBED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277738 ↗
• MalfunctionFeb 3, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE, THE LONG CONNECTION SCREW WAS UNABLE TO BE REMOVED AT THE END OF SURGERY AS THE HEX BALL SCREWDRIVER WOULD NOT CONNECT. THEY HAD TO USE A SWAB WITH SCREWDRIVER TO PROVIDE ENOUGH TRACTION FOR IT TO BE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246821 ↗
• MalfunctionJan 27, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT TIBIA NAIL ADVANCED SYSTEM AIMING ARM MISSING HOLES IN NAIL DESPITE USING PROPER TECHNIQUE WITH NEW CONNECTION BOLT. THE SURGICAL TEAM RESOLVED THE ISSUE BY FREEHANDING THE HOLES IN THE AIMING ARM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192629 ↗
• MalfunctionJan 22, 2026Device-Device Incompatibility

  IT WAS REPORTED DURING AN ADVANCED TIBIAL NAIL PROCEDURE, THE PROXIMAL DRILL GUIDE JIG FAILED THE ALIGNMENT FOR THE PROXIMAL SCREWS. THE TABLE ALIGNMENT TEST WAS SUCCESSFULLY DONE PRIOR TO INSERTING THE NAIL IN THE PATIENT. THE ISSUE CAUSED A SLIGHT SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24145038 ↗
• MalfunctionDec 23, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED DURING A TFN PROCEDURE, THE CLAMPING PIECE FOR SCREWS 5.0, DOES NOT SECURE THE SCREW. THE ISSUE WAS SOLVED BY USING ANOTHER SCREWDRIVER. THERE WAS ALSO AN ISSUE DISASSEMBLING THE CONNECTION SCREW THAT ATTACHES THE NAIL TO THE ARM. THERE WAS NO NEED TO REMOVE THE NAIL. FINALLY, THE SURGERY WAS COMPLETED SUCCESSFULLY, WITHOUT AFFECTING THE PATIENT AND WITHOUT ALTERATIONS IN THE SURGICAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881256 ↗
• MalfunctionDec 19, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THE SUPRAPATELLAR JIG MIS-TARGETED WHILE IMPLANTING THE ADVANCED TIBIAL NAIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23848638 ↗
• MalfunctionDec 18, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THERE WAS MISTARGETING THROUGH THE JIG WITH THE TNA SYSTEM. PRE-CHECKS WERE UNDERTAKEN AND NO ISSUES WERE FOUND. FOLLOWING INSERTION OF THE NAIL, THE CONNECTION SCREW WAS RE TIGHTENED PRIOR TO DRILLING THROUGH THE JIG. WHEN INSERTING PROXIMAL MEDIAL-LATERAL STATIC SCREW, THE DRILL BIT MADE CONTACT WITH THE NAIL. KNEE WAS PLACED INTO MORE FLEXION AND WITH SLIGHT UPWARD PRESSURE ON THE JIG, THE DRILL BIT WENT THROUGH THE NAIL. CASE CONTINUED AND WAS COMPLETED. OCCURRED WHEN UTILIZING THE SUPRAPATELLAR APPROACH AND WITH THE NEW UPDATED TNA CONNECTION SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23839125 ↗
• MalfunctionDec 17, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT 3 PIECES OF THE TIBIAL NAIL AIMING ARM INSTRUMENTS NEED TO BE REPLACED. THE AIMING ARM WAS NOT ATTACHING OR ALIGNING PROPERLY WITH THE NAIL AND WAS CAUSING THE CONNECTING SCREW TO POTENTIALLY CROSS THREAD AND LEAD TO THE LOCKING ALIGNMENT TO BE OFF AXIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23828372 ↗
• MalfunctionDec 15, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THERE WAS MIS-TARGETING OF THE SUPRAPATELLAR JIG DURING SURGERY TO IMPLANT AN ADVANCED TIBIAL NAIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23804021 ↗
• MalfunctionDec 12, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THERE WERE (2) TWO BACK-TO-BACK INTRAOPERATIVE TIBIA NAIL CASES ON (B)(6) 2025. DURING BOTH CASES, THE SURGEON COMPLAINED THAT THE AIMING ARM WAS EXTREMELY DIFFICULT TO OPERATE, AND THE DRILL THROUGH THE PROXIMAL AIMING ARM/TROCARS HIT THE NAIL IN BOTH CASES. THEY WERE ABLE TO SUCCESSFULLY COMPLETE THE SURGERIES, BUT THESE COMPLICATIONS ADDED EXTRA TIME TO BOTH CASES. THE CONNECTING SCREWS ARE OF CONCERN AS WELL GIVEN THE DRILL BITS HITTING THE NAILS. (B)(4) ARE LINKED; ONE COMPLAINT FOR EACH CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23794141 ↗
• MalfunctionDec 12, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THERE WERE (2) TWO BACK TO BACK INTRAOPERATIVE TIBIA NAIL CASES ON (B)(6)2025. DURING BOTH CASES, THE SURGEON COMPLAINED THAT THE AIMING ARM WAS EXTREMELY DIFFICULT TO OPERATE, AND THE DRILL THROUGH THE PROXIMAL AIMING ARM/TROCARS HIT THE NAIL IN BOTH CASES. THEY WERE ABLE TO SUCCESSFULLY COMPLETE THE SURGERIES, BUT THESE COMPLICATIONS ADDED EXTRA TIME TO BOTH CASES. THE CONNECTING SCREWS ARE OF CONCERN AS WELL GIVEN THE DRILL BITS HITTING THE NAILS. (B)(4) AND (B)(4) ARE LINKED; ONE COMPLAINT FOR EACH CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23794108 ↗
• MalfunctionDec 12, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THERE WERE (2) TWO BACK-TO-BACK INTRAOPERATIVE TIBIA NAIL CASES ON (B)(6) 2025. DURING BOTH CASES, THE SURGEON COMPLAINED THAT THE AIMING ARM WAS EXTREMELY DIFFICULT TO OPERATE, AND THE DRILL THROUGH THE PROXIMAL AIMING ARM/TROCARS HIT THE NAIL IN BOTH CASES. THEY WERE ABLE TO SUCCESSFULLY COMPLETE THE SURGERIES, BUT THESE COMPLICATIONS ADDED EXTRA TIME TO BOTH CASES. THE CONNECTING SCREWS ARE OF CONCERN AS WELL GIVEN THE DRILL BITS HITTING THE NAILS. (B)(4) ARE LINKED; ONE COMPLAINT FOR EACH CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23794096 ↗
• MalfunctionDec 12, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THERE WERE (2) TWO BACK-TO-BACK INTRAOPERATIVE TIBIA NAIL CASES ON (B)(6) 2025. DURING BOTH CASES, THE SURGEON COMPLAINED THAT THE AIMING ARM WAS EXTREMELY DIFFICULT TO OPERATE, AND THE DRILL THROUGH THE PROXIMAL AIMING ARM/TROCARS HIT THE NAIL IN BOTH CASES. THEY WERE ABLE TO SUCCESSFULLY COMPLETE THE SURGERIES, BUT THESE COMPLICATIONS ADDED EXTRA TIME TO BOTH CASES. THE CONNECTING SCREWS ARE OF CONCERN AS WELL GIVEN THE DRILL BITS HITTING THE NAILS. (B)(4) ARE LINKED; ONE COMPLAINT FOR EACH CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23794090 ↗
• MalfunctionDec 12, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THERE WERE (2) TWO BACK-TO-BACK INTRAOPERATIVE TIBIA NAIL CASES ON (B)(6) 2025. DURING BOTH CASES, THE SURGEON COMPLAINED THAT THE AIMING ARM WAS EXTREMELY DIFFICULT TO OPERATE, AND THE DRILL THROUGH THE PROXIMAL AIMING ARM/TROCARS HIT THE NAIL IN BOTH CASES. THEY WERE ABLE TO SUCCESSFULLY COMPLETE THE SURGERIES, BUT THESE COMPLICATIONS ADDED EXTRA TIME TO BOTH CASES. THE CONNECTING SCREWS ARE OF CONCERN AS WELL GIVEN THE DRILL BITS HITTING THE NAILS. (B)(4) AND (B)(4) ARE LINKED; ONE COMPLAINT FOR EACH CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23792577 ↗
• MalfunctionDec 12, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THERE WERE (2) TWO BACK-TO-BACK INTRAOPERATIVE TIBIA NAIL CASES ON (B)(6) 2025. DURING BOTH CASES, THE SURGEON COMPLAINED THAT THE AIMING ARM WAS EXTREMELY DIFFICULT TO OPERATE, AND THE DRILL THROUGH THE PROXIMAL AIMING ARM/TROCARS HIT THE NAIL IN BOTH CASES. THEY WERE ABLE TO SUCCESSFULLY COMPLETE THE SURGERIES, BUT THESE COMPLICATIONS ADDED EXTRA TIME TO BOTH CASES. THE CONNECTING SCREWS ARE OF CONCERN AS WELL GIVEN THE DRILL BITS HITTING THE NAILS. (B)(4) ARE LINKED; ONE COMPLAINT FOR EACH CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23792526 ↗
• MalfunctionDec 12, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THERE WERE (2) TWO BACK-TO-BACK INTRAOPERATIVE TIBIA NAIL CASES ON (B)(6) 2025. DURING BOTH CASES, THE SURGEON COMPLAINED THAT THE AIMING ARM WAS EXTREMELY DIFFICULT TO OPERATE, AND THE DRILL THROUGH THE PROXIMAL AIMING ARM/TROCARS HIT THE NAIL IN BOTH CASES. THEY WERE ABLE TO SUCCESSFULLY COMPLETE THE SURGERIES, BUT THESE COMPLICATIONS ADDED EXTRA TIME TO BOTH CASES. THE CONNECTING SCREWS ARE OF CONCERN AS WELL GIVEN THE DRILL BITS HITTING THE NAILS. (B)(4) ARE LINKED; ONE COMPLAINT FOR EACH CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23792443 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201336. 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 Adva
• 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 Adva