NA 03.037.012Recalls & reported problems

Summary

The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 10886982070289), received between Apr 10, 2017 and Sep 29, 2026 — classified as 7 injuries, 68 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (56 reports).

9 other recalls cover devices cleared under the same FDA submission (K131548); 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 25 most recent of 75 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936864 ↗
• MalfunctionSep 29, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931446 ↗
• MalfunctionSep 25, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902675 ↗
• MalfunctionSep 18, 2026Device-Device Incompatibility; Material Twisted/Bent

  It was reported that the insertion handle attachment for TFNA cross threaded and will not catch driving cap. There was no patient harm or surgical delay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819185 ↗
• MalfunctionSep 14, 2026Break; Corroded; Material Twisted/Bent

  It was reported several instruments were found broken, stripped, and rusted. No patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50753784 ↗
• MalfunctionJul 28, 2026Break; Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50059164 ↗
• MalfunctionMay 8, 2026Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2026 THAT TFNA JIG IS HINDERING DRILLS FROM GOING THROUGH THE ROD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25125476 ↗
• MalfunctionMay 8, 2026Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2026 THAT TFNA JIG IS HINDERING DRILLS FROM GOING THROUGH THE ROD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25125458 ↗
• MalfunctionApr 27, 2026Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED THAT DURING INTRAMEDULLARY NAILING OF THE FEMUR, THE TFNA INSERTION HANDLE HAD A LOOSE OUTER HOUSING UNIT FOR THE CONNECTING SCREW. THE DEVICE ROTATED IN FULL CIRCLE AS THE HEX DRIVER WAS USED TO CONNECT THE IMPLANT TO THE CONNECTING SCREW, RESULTING IN THE NAIL/IMPLANT ROTATING ALONG WITH THE CONNECTING SCREW. THIS EVENT CAUSED A FIVE-MINUTE DELAY IN SURGERY, NECESSITATING THE OPENING OF A SECOND INSERTION SET. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25007764 ↗
• MalfunctionFeb 17, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT INSERT-HANDLE, AIM-ARM 125° F/STAT DIST LOCK, BLADE/SCREW GUIDE SLEEVE, DRILLSL YELL, TROCAR YELL, BUTTRESS/COMPR-NUT, SCREW INSERTER, CONNECSCR F/TFNA HELICAL BLADE+SCR, DHS® TRIPLE REAMER, COMPLETE, WITH LONG REAMER, AND FLEX SFT CONNECTOR FOR USE JACOBS CHUCK WERE ASSOCIATED WITH ISSUES INCLUDING IMPROPER POSITIONING OF GUIDE WIRES BY INSERTION HANDLES AND GUIDES, DEFORMATION OF T HANDLES FOR LAG SCREWS MAKING INSERTION DIFFICULT, DAMAGE TO THE DHS REAMER RENDERING IT UNSAFE FOR USE, REAMER ADAPTERS BECOMING JAMMED, AND A BENT RADIOGRAPHIC RULER. THE EVENT OCCURRED PRE-OPERATIVELY AND DID NOT INVOLVE THE PATIENT, NOR DID IT OCCUR DURING STERILE PROCESSING OR FIELD INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24363643 ↗
• MalfunctionFeb 6, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED ON AN UNKNOWN DATE THAT TFNA INSERTION HANDLES AND GUIDES WERE NOT POSITIONING THE GUIDE WIRES CORRECTLY. AIMING ARMS WERE STARTING TO BECOME JAMMED AND WERE BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24280614 ↗
• MalfunctionFeb 6, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED ON AN UNKNOWN DATE THAT TFNA INSERTION HANDLES AND GUIDES WERE NOT POSITIONING THE GUIDE WIRES CORRECTLY. AIMING ARMS WERE STARTING TO BECOME JAMMED AND WERE BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24280606 ↗
• MalfunctionFeb 6, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED ON AN UNKNOWN DATE THAT TFNA INSERTION HANDLES AND GUIDES WERE NOT POSITIONING THE GUIDE WIRES CORRECTLY. AIMING ARMS WERE STARTING TO BECOME JAMMED AND WERE BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24280525 ↗
• MalfunctionFeb 5, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE GUIDE WIRE MISSED THE NAIL HOLE FOR HELICAL BLADE. SURGERY WAS DELAYED FOR FORTY (40) MINUTES DUE TO THE REPORTED EVENT. THE NAIL WAS REMOVED AND REINSERTED USING SECOND SET. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24273312 ↗
• MalfunctionJan 29, 2026Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT A TFNA CONNECTION JIG EXPERIENCED WEAR AND TEAR INTRA-OPERATIVELY, RESULTING IN THE DEVICE NO LONGER CONNECTING AND STAYING ALIGNED. THIS MISALIGNMENT LED TO THE SURGEON MISSING THE BLADE HOLE DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24210182 ↗
• MalfunctionJan 22, 2026Break

  IT WAS REPORTED THAT DURING AN ORTHOPEDIC PROCEDURE, THE INSERT-HANDLE, DEPTH GAUGE F/SCR Ø2+2.4 MEAS-RANGE UP-T, AND COLLINEAR REDUCTION CLAMP SLIDING MECHAN WERE INVOLVED IN A REPORTED EVENT. THE EVENT INVOLVED A DAMAGED HANDLE THAT COULD NOT GUARANTEE STERILITY, A BROKEN DEPTH GAUGE, AND A BROKEN HANDLE OF A CLAMP. THERE WAS NO REPORTED CONSEQUENCE OR IMPACT TO THE PATIENT, AND NO SIGNS, SYMPTOMS, OR PATIENT INVOLVEMENT WERE IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24148629 ↗
• MalfunctionJan 9, 2026Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE TFNA NAIL HANDLE DOES NOT ALLOW FOR CORRECT TIGHTENING OF THE NAIL. THE HANDLE TURNS WITH THE NAIL WHEN TIGHTENING WITH THE CONNECTING BOLT. THIS COULD BE DUE TO WEAR AND TEAR OVER TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24020965 ↗
• MalfunctionDec 3, 2025Break; Break

  IT WAS REPORTED THE INSTRUMENTS ARE BROKEN. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23704797 ↗
• MalfunctionNov 24, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2025 THAT STAFF INFORMED WHILE USING THE TFNA INSTRUMENTATION FOR A HIP FRACTURE, THE PIN MISSED THE NAIL THROUGH THE AIMING JIG. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23639017 ↗
• MalfunctionNov 14, 2025Break; Break

  IT WAS REPORTED THAT THE INSERTION HANDLE BROKE. THE ATTACHMENT POINT FOR THE NAIL CAME LOOSE CAUSING THE NAIL TO SPIN ON THE INSERTION HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556950 ↗
• MalfunctionOct 22, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2025 THAT THE CONNECTING BOLT BELIEVED TO BE COLD WELDED ON THE NAIL AND WAS UNABLE TO REMOVE THE NAIL FROM THE AIMING ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23358454 ↗
• MalfunctionSep 2, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT WHILE CONNECTING THE TFNA INSERTION HANDLE TO TFNA, THE METAL CONNECTION POINT LOOSENED AND ROTATED WITH NAIL WHILE TIGHTENING THE CONNECTION SCREW, THUS MISALIGNING THE AIMING ARM. THIS OCCURRED BEFORE PATIENT WAS IN THE ROOM WHILE ASSEMBLING A 11MM X 170MM TFNA. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22936331 ↗
• MalfunctionAug 4, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, AN ISSUE OCCURRED IN PRE-OP DURING SETUP FOR A TFNA. THE INSERTION ARM AND AIMING ARM FOR THE 300 DEGREE NAIL WERE NOT PROPERLY ALIGNED, WHICH WOULD HAVE RESULTED IN MISPLACEMENT OF LAG SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22703305 ↗
• MalfunctionJul 18, 2025Break; Break

  IT WAS REPORTED THAT THERE WAS A BROKEN TFNA JIG FROM THE HOSPITAL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22541225 ↗
• MalfunctionApr 24, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT A TFNA AIMING ARM APPEARS BENT AND WAS NOT ALIGNING PROPERLY. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21902341 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131548. One submission often covers many models, so check the product and lot details in each record.

• Z-1239-2024 · Jan 24, 2024 · Open, Classified
  TFNA Femoral Nail 9mm, right, 130, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.944S
• Z-1240-2024 · Jan 24, 2024 · Open, Classified
  TFNA Femoral Nail 11mm, right, 130, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.144S
• Z-1248-2023 · Feb 1, 2023 · Open, Classified
  TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures Part Number: 04.037.242S
• Z-1246-2023 · Feb 1, 2023 · Open, Classified
  TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.213S
• Z-1247-2023 · Feb 1, 2023 · Open, Classified
  TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.212S
• Z-0126-2016 · Sep 21, 2015 · Terminated
  Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head element inserter to prevent disengagement during head eleme
• Z-2091-2015 · Jun 10, 2015 · Terminated
  Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent disengagement during head element
• Z-1600-2015 · Apr 9, 2015 · Terminated
  TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
• Z-1352-2015 · Feb 24, 2015 · Terminated
  Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proxima