NA 03.037.014Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10886982070302), received between Feb 4, 2019 and Sep 29, 2026 — classified as 2 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (37 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Break

  It was reported that the stepped ream for TFNA helical blade and screw was used during insertion of a TFNA nail. During preparation for the proximal locking portion of the case, the 10 mm cannulated drill bit was used without incident, after which the 6/9 tapered drill bit fractured at the tip in the femoral neck and was described as crumbling like dust after brief contact in the patient. It was also reported that substantial torque was applied to the insertion handle and aiming arm jig to achieve trajectory and reduction, and that the 3.2 guide wire bent during insertion of the lag screw head element. Additional impacted products were the insert handle, 3.2 mm wire guide sleeve, lock insert for aim arm, 3.2 mm trocar, blade/screw guide sleeve, and 125 degree aiming arm. Fragments were generated, retained in the patient, and additional intervention was required to remove the retained fragments.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937175 ↗
• MalfunctionSep 25, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902645 ↗
• MalfunctionMay 1, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE OUTER DRILL BIT HIT THE NAIL AND METAL SHAVINGS WERE GENERATED. THE INSERTION HANDLE AND OUTER AIMING ARM ARE NOT HOLDING ALIGNMENT CORRECTLY LEADING TO THE DRILL BIT HITTING THE NAIL, AND CAUSING A SURGICAL DELAY. THE ORIGINAL NAIL WAS DISCARDED, A NEW NAIL WAS INSERTED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25058206 ↗
• MalfunctionFeb 17, 2026Material Deformation; Mechanical Jam

  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 24363672 ↗
• MalfunctionFeb 6, 2026Material Deformation; Mechanical Jam

  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 24280603 ↗
• MalfunctionFeb 6, 2026Material Deformation; Mechanical Jam

  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 24280602 ↗
• MalfunctionFeb 6, 2026Material Deformation; Mechanical Jam

  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 24280522 ↗
• MalfunctionNov 14, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS HARD TO SLIDE SLEEVES INTO THE GUIDE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23559820 ↗
• MalfunctionNov 14, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS HARD TO SLIDE SLEEVES INTO THE GUIDE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23559818 ↗
• MalfunctionNov 14, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS HARD TO SLIDE SLEEVES INTO THE GUIDE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23559817 ↗
• MalfunctionSep 30, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025 THE TFNA 125 AIMING ARM BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23183142 ↗
• MalfunctionApr 28, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ANTI ROTATION PINS HIT THE NAIL, THE OPENING REAMER FOR LAG SCREW HIT THE NAIL, AND REAMED PART OF NAIL. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES. ORIGINAL COMPLAINT IN (B)(4) INVOLVES 27 PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919451 ↗
• MalfunctionApr 28, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ANTI ROTATION PINS HIT THE NAIL, THE OPENING REAMER FOR LAG SCREW HIT THE NAIL, AND REAMED PART OF NAIL. SURGEONS WANT ALL PARTS REPLACED FOR ALL PANS, WAS NOT PRESENT IN THE CASE. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919403 ↗
• MalfunctionFeb 24, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT TWO OF THE 125 AIMING ARMS WILL NOT SECURE THE THREADED SLEEVE/BUTTRESS NUT. FOUR AIMING ARMS HAVE DAMAGE/WEAR VISIBLE ON THE CARBON FIBER. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21446874 ↗
• MalfunctionFeb 24, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT TWO OF THE 125 AIMING ARMS WILL NOT SECURE THE THREADED SLEEVE/BUTTRESS NUT. FOUR AIMING ARMS HAVE DAMAGE/WEAR VISIBLE ON THE CARBON FIBER. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21446839 ↗
• MalfunctionNov 26, 2024Use of Device Problem; Device-Device Incompatibility; Use of Device Problem; Device-Device Incompatibility

  ON ONE KIT TFNA IT WAS NOTICED THE FOLLOWING ISSUES: THE RED AND YELLOW MARKINGS ON THE GUIDE SLEEVE AS WELL AS THOSE OF THE IMPACTOR ARE ERASED. THE TWO CONNECTION SCREWS DO NOT FIT WITH THE HEXAGON SCREWDRIVER 8MM. THESE REFERENCES ARE SUPPOSED TO ALLOW GRIPPING. THE PROTECT SLEEVE DOES NOT FIT PROPERLY INTO THE CARBON AIM ARMS AND SLIPPING, WHICH IS ANNOYING DURING THE INTERVENTION. CARBON AIM ARMS ARE INCOMPLETE: THE "RING" VISIBLE IS MISSING. THE LISTING OF THIS INSTRUMENT IS, IN FACT, UNCLEAR. THESE REFERENCES SHOULD INCLUDE THREE ELEMENTS (CARBON VISOR, SCREW AND RING), EACH WITH ITS OWN REFERENCE. ISSUE NOTICED BY THE SALES REP DURING A TRAINING WITH THE USERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20777505 ↗
• MalfunctionNov 6, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO FRAGMENTS GENERATED AND NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20619492 ↗
• MalfunctionSep 30, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE GUIDES AND OR AIMING ARM WEREN'T ALLOWING FOR EASY INSERTION OF BLADE OR SCREW. DOCTOR REQUESTED REPLACEMENT. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A 125 DEG AIMING ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20334539 ↗
• MalfunctionSep 26, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE GUIDES AND OR AIMING ARM WERE "TAUGHT" AND WASN'T ALLOWING FOR EASY INSERTION OF BLADE OR SCREW. THERE WAS NO PATIENT CONSEQUENCES. AND NO ADDITIONAL INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20313153 ↗
• MalfunctionSep 23, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DISTAL LOCKING SCREW MISSED THE NAIL THAT WAS GUIDED THROUGH TROCARS IN THE AIMING ARM. AIMING ARM WAS NOT FULLY TIGHTENING TO INSERTION HANDLE. THERE SEEMED TO BE NO OTHER ISSUES WITH DISTAL LOCKING SCREW, INSERTION HANDLE, TROCAR, OR NAIL. SURGERY WAS COMPLETED SUCCESSFULLY AFTER IMPLANTING THE DISTAL LOCKING SCREW WITHOUT THE AIMING ARM, BUT THE PROCEDURE WAS DELAYED BY 45 MINUTES DUE TO THE REPORTED EVENT. IT WAS REPORTED THAT THE OUTCOME OF THE CASE SEEMED TO BE FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20278723 ↗
• MalfunctionAug 9, 2024Break; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility; Break; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE HAD BEEN ISSUES WITH THE STERILIZATION/ASSEMBLY, AS WELL AS CHIPPING AND CRACKING, MAKING THE ITEMS IMPOSSIBLE TO USE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 125 DEG AIMING ARM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19949250 ↗
• MalfunctionAug 9, 2024Break; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility; Break; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE HAD BEEN ISSUES WITH THE STERILIZATION/ASSEMBLY, AS WELL AS CHIPPING AND CRACKING, MAKING THE ITEMS IMPOSSIBLE TO USE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 125 DEG AIMING ARM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19949248 ↗
• MalfunctionAug 9, 2024Break; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility; Break; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE HAD BEEN ISSUES WITH THE STERILIZATION/ASSEMBLY, AS WELL AS CHIPPING AND CRACKING, MAKING THE ITEMS IMPOSSIBLE TO USE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 125 DEG AIMING ARM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19949236 ↗
• MalfunctionMar 8, 2024Break; Crack; Break; Crack

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE AIMING ARM IS CRACKED AND BROKEN. THIS REPORT IS FOR ONE 125 DEG AIMING ARM FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18870239 ↗
• MalfunctionFeb 9, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DURING THE PROCEDURE, THE SURGEON HIT THE AIMING ARM CAUSING IT TO NOT LINE UP. SURGERY WAS COMPLETED SUCCESSFULLY WITH A 5 MINUTE SURGICAL DELAY. THERE WAS NO ADVERSE PATIENT IMPACT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18675277 ↗

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-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-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-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