TFN-ADVANCE 04.038.200SRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886982098771), received between Mar 21, 2019 and Jun 28, 2024 — classified as 8 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (6 reports).

2 other recalls cover devices cleared under the same FDA submission (K160167); 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJun 28, 2024Migration; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT FELL AND THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) FENESTRATED SCREW MIGRATED THROUGH THE PATIENT'S FEMORAL HEAD INTO THE PELVIS. PATIENT WAS REVISED TO A TOTAL HIP. THIS REPORT IS FOR A TFNA FENESTRATED SCREW 100MM - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 19638348 ↗
• MalfunctionSep 12, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED ON (B)(6) 2023, THAT THE SURGEON WAS FIXING A HIP FRACTURE WITH A TFNA NAIL AND A 100 MM TFNA FENESTRATED LAG SCREW. DURING THE PROCEDURE WE COULD NOT GET THE COUPLING SCREW TO THREAD IN TO THE BACK OF THE LAG SCREW SO THEY OPENED ANOTHER INSTRUMENT SET AND THEY TRIED A DIFFERENT CONNECTING SCREW WHICH ALSO DID NOT WORK. THEY THEN OPENED A SECOND 100 MM LAG SCREW AND IT WORKED PERFECTLY SO THE FIRST ONE HAS DEFECTIVE THREADS. THE SURGERY WAS SUCCESSFULLY COMPLETED. PATIENT STATUS/ OUTCOME: SUCCESSFUL. CONCOMITANT DEVICE REPORTED: UNK - NAILS: TFNA ( PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 100MM - STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17730335 ↗
• MalfunctionSep 8, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2023, ONE OF THE TEAM ASSOCIATES HAD REACHED OUT TO SALES REP ABOUT COMPRESSING THE TFNA WITH THE LAG SCREW AFTER A CASE HAD JUST COVERED. THE EMPLOYEE HAD THOUGHT THAT TIGHTEN DOWN THE SET SCREW AND TORQUE DOWN BEFORE COMPRESSING, AND THAT'S WHAT OCCURRED DURING THE PROCEDURE WHEN THE SURGEON ATTEMPTED TO COMPRESS. SALES REP INFORMED THE EMPLOYEE OF THE NEED TO BACK OFF THE SCREW A HALF OF TURN IN ORDER TO COMPRESS THE NAIL FRACTURE BEFORE STATICALLY LOCKING, IF THAT¿S THE CHOICE. IT WAS NOT KNOWN IF ANY ADVERSE EVENTS OCCURRED DURING THE PROCEDURE. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THIS REPORT INVOLVES ONE TFNA FENESTRATED SCREW 100MM - STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17714302 ↗
• MalfunctionAug 21, 2023Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2023 TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) 95MM PATIENT WITH HARD BONE TO FENESTRATED LAG SCREW AND THE DOCTOR DECIDED TO HAPPEN AND WHAT WAS HAPPENED THAT THE FORCE T- HANDLE END OF LAG SCREW INSERTER FRAGMENT TO BONE AND END OF THAT STRIPPED LITTLE BIT ON IT. SO, WHEN LOCKING DOWN THE LAG SCREW WITH NAIL THE SCREW INSERTION HANDLE IT WAS TOGGLE WHICH WAS NORMAL UPON THEN X-RAYS TO END OF THE CASE APPEAR THAT END OF THAT LAG SCREW WAS STRIPPED AND LITTLE BIT BEND AND HAD NO FRAGMENT. THE CASE WAS COMPLETED AND JUST TO CHECK X-RAY COMPLETED, LAG SCREW WAS AGAIN PROBLEM OR NOT BUT THIS WAS LAYERED. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 100MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17585618 ↗
• MalfunctionJun 2, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2023, 100MM TROCHANTERIC FEMORAL NAIL ADVANCED(TFNA) LAG SCREW GOT STUCK IN INSERTION TUBE DURING INSERTION. THE INTERFACE WITH T-HANDLE INSERTER AND LAG SCREW TOGGLES AND DOESN¿T SIT PROPERLY. THE LAG SCREW THREADS CAUGHT THE INSERTER CAUSING THE THREADS TO STRIP AND DIFFICULTY PASSING THROUGH GUIDE TUBE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TEN(10) MIN SURGICAL DELAY. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 100MM - STERILE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17051908 ↗
• InjuryApr 26, 2023Break; Migration; Break; Migration

  THIS IS A LEGAL COMPLAINT IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT BROUGHT TO THE ER WITH THE LEFT HIP PAIN AFTER A FALL. ON (B)(6) 2020, THE PATIENT UNDERWENT CEPHALOMEDULLARY FIXATION OF LEFT PERITROCHANTERIC FEMUR FRACTURE. ON (B)(6) 2020, SHE REPORTS SORENESS AND A POPPING SENSATION WHENEVER SHE FLEXES HER HIP. SORENESS AND PAIN WHENEVER SHE DOES ANY ABDUCTION MOVEMENTS. DEXA SCAN SHOWING OSTEOPOROSIS. ON (B)(6) 2021, CT SCAN OF THE HIP SHOWS A SMALL CRACK IN THE LAG SCREW. THERE IS BONY CALLUS FORMATION OVER THE BROKEN SCREW. ON (B)(6) 2022, SHE HAD DEVELOPED A VERY PROMINENT LAG SCREW FROM HER CEPHALOMEDULLARY NAIL. OF NOTE THE TIP OF THE LAG SCREW HAD BROKEN. ON (B)(6) 2022, THE PATIENT UNDERWENT LEFT FEMUR REMOVAL OF HARDWARE AND LEFT SUBTROCHANTERIC FEMUR DELAYED-UNION REPAIR WITH EXCHANGE OF CEPHALOMEDULLARY NAIL. THIS COMPLAINT INVOLVES ONE (1) DEVICES. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 100MM - STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16818626 ↗
• MalfunctionMar 17, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2023 THAT THE LAG SCREW WHERE A GUIDE WIRE WOULD PASS THROUGH THE LAG SCREW BUT LAG SCREW DIDN¿T GO WHILE CONNECTED TO INSERTION HANDLE. THERE WAS NO PATIENT INVOLVEMENT THIS COMPLAINT INVOLVE ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 100MM - STERILE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16565399 ↗
• InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023 DURING AN UNKNOWN PROCEDURE AFTER INSERTING THE LAG SCREW, IT WAS NOTICED THAT THE PROXIMAL FRAGMENT HAS ROTATED CAUSE SOME MAL REDUCTION. THE SURGEONS DECIDED TO LEAVE IT AND IT WAS ACCEPTED. ADDITIONALLY THE AIMING ARM LOCKING DEVICE FELL OFF DURING SURGERY. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 100MM - STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Physical Asymmetry

  MAUDE report 16491618 ↗
• InjuryFeb 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT HARDWARE REMOVAL OF TFNA NAIL, LAG SCREW AND DISTAL SCREWS. TRANSITIONED/REVISED PATIENT TO A TOTAL HIP ARTHROPLASTY. PATIENT OUTCOME IS UNKNOWN. THIS REPORT INVOLVES (1) TFNA FENESTRATED SCREW 100MM - STERILE. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13515075 ↗
• InjuryOct 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT REMOVAL OF TFNA DUE TO NONUNION IN THE FEMORAL NECK. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 100MM - STERILE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12698689 ↗
• MalfunctionNov 11, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING A TFNA PROCEDURE, THE SURGEON REPORTED BINDING BETWEEN THE DRILL BIT AND THE NAIL WHEN OPENING THE LATERAL CORTEX FOR THE FENESTRATED SCREW. THE SURGEON CONFIRMED THE NAIL DEGREE AND AIMING ARM MATCHED WITH A DROP TEST AND CONDUCTED WITH BOTH GUIDE SLEEVES / TROCARS. CURRENTLY, IT IS SUSPECTED THIS OCCURRED DUE TO PERHAPS TWO THINGS: FIRST, A VERY SLIGHT FLEXION BETWEEN THE AIMING ARM AND THE INSERTION HANDLE WHEN ADJUSTING FOR ANTEVERSION. WITH A TIGHT INCISION THAT ADJUSTMENT COULD PUSH THE DEEP TISSUE AGAINST THE TROCAR, AND THE SMALL FLEX COULD CAUSE MISALIGNMENT. DURING THIS CASE, HOWEVER, HE DID NOT HAVE TO ADJUST MUCH IF AT ALL. SECOND REPEATED FORCEFUL MALLET BLOWS CAN SOMETIMES BACK OUT THE CONNECTING SCREW BETWEEN THE HANDLE/NAIL ENOUGH TO ALLOW FOR MINUTE PLAY BETWEEN THE TWO. SO, WE'RE GETTING SCREW BACKING OUT BUT IT'S OUR SUSPICION, OTHERWISE, WE NEED TO REPORT THIS. NO ONE ELSE WAS HURT. THERE WAS NO TIME LOSS MAYBE A COUPLE OF SECONDS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS FINE. CONCOMITANT DEVICE REPORTED: UNK - IMPACTION INST: HAMMER/MALLET: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN) THI

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10824514 ↗
• InjuryAug 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A PROCEDURE TO HAVE THE TFNA SYSTEM IMPLANTED. DURING THE PROCEDURE, THE SURGEON INTRODUCED THE NAIL, PASSED THE TRACTION SCREW, LOCKED IT AND WHEN THE COMPRESSION WAS MADE, THE FRACTURE IS DISTRACTED. THE SURGEON PERFORMED AUGMENTATION IN WHICH THE CEMENT CAME OUT AND WENT TO THE FOCUS OF THE FRACTURE WITHOUT LEAVING IT. THERE WAS PATIENT CONSEQUENCE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 100MM - STERILE. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10462213 ↗
• InjuryAug 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE, THE SURGEON INTRODUCED THE NAIL, PASSED THE TRACTION SCREW, LOCKED IT AND WHEN THE COMPRESSION WAS MADE, THE FRACTURE IS DIASTATED. THE SURGEON PERFORMED AUGMENTATION IN WHICH THE CEMENT CAME OUT AND WENT TO THE FOCUS OF THE FRACTURE WITHOUT LEAVING IT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS REPORTED AS STABLE. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICES REPORTED: UNKNOWN NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1) . THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 100MM - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10457737 ↗
• InjuryMar 21, 2019Device-Device Incompatibility; Device-Device Incompatibility

  WHEN ATTEMPTING TO SCREW THE AIMING ARM INTO THE INSERTION HANDLE, IT FELT CROSS THREADED. IT DID NOT FEEL SMOOTH GOING INTO THE HOLE THREADS TO CONNECT THE TWO PIECES.

  Patient problems: No Code Available

  MAUDE report 8440782 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160167. One submission often covers many models, so check the product and lot details in each record.

• 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-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