TFN-ADVANCE 04.037.031SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982095893), received between Jun 1, 2018 and Jun 8, 2020 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Disassembly” (2 reports).

9 other recalls cover devices cleared under the same FDA submission (K131548, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 2020Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING A HIP SURGERY WHILE DOING PROXIMAL FEMORAL NAILING SYSTEM (TFNA) ON A MIDSHAFT FEMUR FRACTURE, THE FRACTURE WAS REDUCED, REAMED AND IMPLANTED USING A TFNA NAIL. AFTER GETTING THE TFNA NAIL DOWN THE CANAL, THE TRIPLE SLEEVE WAS USED TO INSERT THE UNKNOWN LAG SCREW. THE SURGEON PROCEEDED WITH THE STEPS AND INSERTED THE UNKNOWN LAG SCREW. THE SURGEON WAS UNSUCCESSFUL IN LOCKING THE SET SCREW. IT WAS FOUND THAT THE NAIL DISCONNECTED FROM THE UNKNOWN AIMING ARM AND THE UNKNOWN LAG SCREW MISSED THE HOLE IN THE NAIL. THE SURGEON PROCEEDED TO EXTRACT THE NAIL AND WAS SUCCESSFUL IN REMOVING IT WITH THE EXTRACTION HOOK. THE SURGEON OPENED A NEW NAIL AND PROPERLY ASSEMBLED IT ONTO THE AIMING ARM BEFORE IMPLANTING THE NEW NAIL AND UNKNOWN LAG SCREW AND PROCEEDING WITH THE REST OF THE CASE. THERE WAS A ONE HUNDRED TWENTY (120) MINUTE SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR (1) 10MM/125 DEG TI CANN TFNA 400MM/LEFT ¿ STERILE. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: Injury; No Code Available

  MAUDE report 10129285 ↗
• MalfunctionJun 1, 2018Disassembly; Disassembly

  IT WAS REPORTED THAT ON (B)(6) 2018, A PATIENT UNDERWENT A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) PROCEDURE. DURING THE SURGERY, THE SURGEON TRIED TO TAKE OFF THE PERCUTANEOUS RADIOLUCENT INSERTION HANDLE AFTER HAVING PLACED AND LOCKED DOWN THE TFNA FEMORAL NAIL, TITANIUM ALLOY AND LAG SCREW. HOWEVER, THE CONNECTING SCREW FOR INSERTION HANDLE WOULD NOT RELEASE FROM THE NAIL. THE PATIENT¿S LEG WAS ABDUCTED AND THE CONNECTING SCREW COULD NOT BE REMOVED. THE SURGEON THEN REMOVED THE INSTRUMENTATION AND IMPLANTS. A NEW SECOND NAIL OF THE SAME PART AND DIFFERENT SIZED LAG SCREW WERE INSERTED, AND ANOTHER NEW SECOND CONNECTING SCREW AND INSERTION HANDLE WERE USED. THE SAME ISSUE OCCURRED. THE CONNECTING SCREW BECAME STUCK TO THE NAIL WHILE TAKING OFF THE SECOND INSERTION HANDLE. THE SURGEON WAS ABLE TO DISENGAGE THE CONNECTING SCREW FROM THE NAIL. THE SECOND NAIL AND LAG SCREW REMAINED IMPLANTED IN THE PATIENT. IT WAS NOTED THAT THE NAIL WAS NOT FITTING ON PROPERLY, AND THAT THE TIPS OF BOTH INSERTION HANDLES HAD BECOME BENT OR TORQUED. IT WAS ALSO NOTED THAT THE SCREW INSERTER BENT AT THE HANDLE AND THE HELICAL BLADE/SCREW COUPLING SCREW BENT AT THE TIP OF THE THREADS. THERE WAS AN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7561504 ↗
• MalfunctionJun 1, 2018Disassembly; Disassembly

  IT WAS REPORTED THAT ON (B)(6) 2018, A PATIENT UNDERWENT A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) PROCEDURE. DURING THE SURGERY, THE SURGEON TRIED TO TAKE OFF THE PERCUTANEOUS RADIOLUCENT INSERTION HANDLE AFTER HAVING PLACED AND LOCKED DOWN THE TFNA FEMORAL NAIL, TITANIUM ALLOY AND LAG SCREW. HOWEVER, THE CONNECTING SCREW FOR INSERTION HANDLE WOULD NOT RELEASE FROM THE NAIL. THE PATIENT¿S LEG WAS ABDUCTED AND THE CONNECTING SCREW COULD NOT BE REMOVED. THE SURGEON THEN REMOVED THE INSTRUMENTATION AND IMPLANTS. A NEW SECOND NAIL OF THE SAME PART AND DIFFERENT SIZED LAG SCREW WERE INSERTED, AND ANOTHER NEW SECOND CONNECTING SCREW AND INSERTION HANDLE WERE USED. THE SAME ISSUE OCCURRED. THE CONNECTING SCREW BECAME STUCK TO THE NAIL WHILE TAKING OFF THE SECOND INSERTION HANDLE. THE SURGEON WAS ABLE TO DISENGAGE THE CONNECTING SCREW FROM THE NAIL. THE SECOND NAIL AND LAG SCREW REMAINED IMPLANTED IN THE PATIENT. IT WAS NOTED THAT THE NAIL WAS NOT FITTING ON PROPERLY, AND THAT THE TIPS OF BOTH INSERTION HANDLES HAD BECOME BENT OR TORQUED. IT WAS ALSO NOTED THAT THE SCREW INSERTER BENT AT THE HANDLE AND THE HELICAL BLADE/SCREW COUPLING SCREW BENT AT THE TIP OF THE THREADS. THERE WAS AN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7561233 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131548, K160167. 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