TFN-ADVANCE 04.037.242SRecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10886982097262), received between Dec 1, 2017 and Nov 2, 2023 — classified as 20 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (10 reports).

1 FDA recall record name this device's identifier, 1 still open.

8 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.

Recalls naming this device

1. Feb 1, 2023Class IIOpen, Classified

   TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length

   Z-1248-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 2, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2023, A 4.2 DRILL FOR THE DISTAL INTERLOCK SCREW IN A SHORT TFNA MISSED THE SCREW HOLE AND WENT POSTERIOR TO THE NAIL. THE CORRECT SLEEVES AND DRILL WERE USED. THE INSERTION HANDLE WAS REMOVED BECAUSE THE SURGEON NEEDED A CLEAR X-RAY TO GUIDE THE DRILL THROUGH THE NAIL-FREE HAND SURGERY. THERE IS NO "NAIL HEAD". TFNA (TROCHANTERIC FEMORAL NAIL ADVANCED). PATIENT CONSEQUENCES IN RELATION TO THE REPORTED EVENT WERE ADDED TIME AND MORE X-RAYS. THIS REPORT IS FOR ONE (1) 12/130 DEG TI CANN TFNA 170 - STERILE. THIS IS REPORT 1 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18057209 ↗
• InjuryAug 8, 2023Break; Break

  IT WAS REPORTED THAT SURGEON INFORMED THAT ON (B)(6) 2023 A PATIENT WILL UNDERGO A HIP REVISION PROCEDURE WITH REMOVAL OF A TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA) DUE TO TFNA NAIL BREAKAGE. SURGEON INSERTED THE NAIL TWO MONTHS PRIOR WITH A NEAR PERFECT REDUCTION. NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR ONE (1) 12MM/130 DEG TI CANN TFNA 170MM - STERILE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17481436 ↗
• InjuryAug 2, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, A TFNA WAS BEING REMOVED FROM THE PATIENT SO THAT A HIP REPLACEMENT COULD BE PERFORMED. THE TFNA WAS IMPLANTED APPROXIMATELY 6 MONTHS PRIOR. THE TFNA CONSTRUCT HAD FAILED AND THE NAIL WAS FOUND TO BE BROKEN WHERE THE CEPHALOMEDULLARY SCREW ENTERS THE NAIL. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR A 12MM/130 DEG TI CANN TFNA 170MM ¿ STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17442803 ↗
• MalfunctionJun 7, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING A HIP FRACTURE CASE UTILIZING. THE TFNA SYSTEM, THE TFNA NAIL BECAME DETACHED FROM THE INSERTION HANDLE, WHILE THE RESIDENT SURGEON WAS IMPLANTING. THE NAIL WAS REMOVED USING THE PROPER EXTRACTION DEVICE. THE ATTENDING SURGEON DEEMED THE NAIL ¿DEFECTIVE¿ AND REQUESTED A NEW TFNA NAIL BE OPENED AND UTILIZED. CASE COMPLETED WITHOUT FURTHER COMPLICATIONS. NO SURGICAL DELAY. NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) 12MM/130 DEG TI CANN TFNA 170MM - STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17080951 ↗
• InjuryNov 21, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022, THERE WAS A REMOVAL OF A TFNA NAIL, HELICAL BLADE, AND NAIL SCREW THAT HAD CUT OUT OF THE NAIL. THE PATIENT CAME INTO THE EMERGENCY ROOM DUE TO CUT OUT OF TFNA NAIL/HELICAL BLADE. THE TFNA FENESTRATED HELICAL BLADE EXITED MEDIALLY THROUGH THE TFNA SHORT NAIL AND LODGED IN THE PATIENT¿S PELVIS. AFTER REMOVAL OF THE TFNA COMPONENTS, THE PATIENT¿S FRACTURE WAS REPAIRED AGAIN USING NON-SYNTHES IMPLANTS. THE TFNA NAIL WAS EXAMINED AND THERE WAS EVIDENCE THAT THE IMPLANTING SURGEON THAT HAD FIRST FIXED THE FRACTURE DID NOT ENGAGE THE TFNA NAIL SET SCREW. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 12MM/130 DEG TI CANN TFNA 170MM - STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15836399 ↗
• InjuryJul 22, 2022Break; Break

  IT WAS REPORTED A REVISION SURGERY TOOK PLACE ON (B)(6) 2022 DUE TO A FAILED BROKEN IMPLANT. THE SURGEON WILL BE REMOVING A SYNTHES NAIL AND COVERING TO A TOTAL HIP. ORIGINAL IMPLANT DATE NOT KNOWN. THE HARDWARE WAS SUCCESSFULLY REMOVED. THE NAIL WAS BROKEN AT THE HELICAL BLADE SITE. ALL FRAGMENTS WERE REMOVED. THE PATIENT WAS POSITIVE FOR INFECTION. THIS IS REPORT 1 OF 3 FOR (B)(4). THIS REPORT IS FOR THE TFNA NAIL.

  Patient problems: Post Operative Wound Infection

  MAUDE report 15086267 ↗
• InjuryJun 25, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A FEMORAL NAIL REMOVAL OF TITANIUM CANNULATED PROXIMAL FEMORAL NAILING SYSTEM (TFNA) DUE TO TFNA NAIL AND FENESTRATED LAG SCREW WERE BROKEN. THE NAILS WERE REMOVED, AND A TOTAL HIP WAS IMPLANTED. THE PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. CONCOMITANT DEVICE REPORTED. UNKNOWN DISTAL LOCKING SCREW (PART# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN). UNKNOWN END CAPS (PART# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN). THIS COMPLAINT INVOLVES (2) DEVICES. THIS REPORT IS FOR (1) 12/130 DEG TI CANN TFNA 170 - STERILE. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: Necrosis

  MAUDE report 12071080 ↗
• InjuryJun 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT REMOVAL OF THE PROXIMAL FEMORAL NAILING SYSTEM (TFNA) NAIL, TFNA HELICAL BLADE, TFNA END CAP, AND LOCKING SCREW DUE TO THE FRACTURE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY AND NO FRAGMENTS WERE GENERATED. THIS REPORT IS FOR ONE (1) 12MM/130 DEG TI CANN TFNA 170MM - STERILE. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 11925415 ↗
• MalfunctionApr 9, 2021Device-Device Incompatibility; Device-Device Incompatibility

  THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11642153 ↗
• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, INITIALLY SURGEON HAD A SHORT PROXIMAL FEMORAL NAILING SYSTEM (TFNA) PLACED DUE TO A FEMUR FRACTURE. THE PATIENT RETURNED TO THE HOSPITAL WITH A NEW FRACTURE, DISTAL TO THE IMPLANT. EXCHANGE NAILING WAS DONE WITH A LONG TFNA . PROCEDURE IS COMPLETED SUCCESSFULLY AND THE PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 12MM/130 DEG TI CANN TFNA 170MM - STERILE THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 11519540 ↗
• MalfunctionFeb 24, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN, THE TFN-ADVANCED SYSTEM, SHORT NAILS WAS BROKEN. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 12MM/130 DEG TI CANN TFNA 170MM - STERILE. THIS IS REPORT 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11375121 ↗
• MalfunctionOct 19, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT UNDERWENT A HIP SURGERY. DURING THE SURGERY, WHILE THE SURGEON WAS PUTTING THE DISTAL INTERLOCKING SCREW IN THE PROXIMAL FEMORAL NAILING SYSTEM (TFNA) SHORT NAIL, THE DRILL HIT THE NAIL AND DID NOT PASS. THE SURGEON REMOVED THE HANDLE AND FREE HANDING THE DRILL BIT AND SCREW. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A FIFTEEN (15) MINUTE SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1), UNKNOWN DRILL BIT (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR ONE (1) 12MM/130 DEG TI CANN TFNA 170MM - STERILE. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10698061 ↗
• InjuryOct 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2020, A REVISION SURGERY OCCURRED FOR REMOVAL OF HARDWARE DUE TO NONUNION. THE ORIGINAL DATE OF IMPLANTATION WAS ON (B)(6) 2020. THE PROCEDURE OUTCOME WAS UNKNOWN. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 10677416 ↗
• MalfunctionAug 25, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING A HIP FRACTURE SURGERY WHEN THE SURGEON WENT TO LOCK THE INTERNAL SECTOR FOR PROXIMAL FEMORAL NAILING SYSTEM (TFNA) IMPLANT TO LOCK DOWN THE UNKNOWN LAG SCREW, THE SURGEON COULD NOT GET THE INTERNAL SCREW. IT IS STILL CONNECTED. THEY REMOVED THE INSERTION HANDLE. THE ENTIRE CONSTRUCT WAS REMOVED AND WAS REPLACED WITH ALL NEW IMPLANTS. THERE WAS A SURGICAL DELAY OF ABOUT ONE (1) HOUR TO REMOVE THE IMPLANT. THE OUTCOME WAS SUCCESSFUL. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN INSERTION HANDLE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN TFNA LAG SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 12MM/130 DEG TI CANN TFNA 170MM - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10451649 ↗
• InjuryMar 24, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REMOVAL OF BROKEN TITANIUM CANNULATED PROXIMAL FEMORAL NAILING SYSTEM (TFNA). THE NAIL BROKE AT THE HELICAL BLADE SLOT AND IT WAS DIFFICULT TO REMOVE WHICH REQUIRED EXTRACTION HOOK TO REMOVE THE DISTAL PORTION OF THE NAIL. COMPLETELY REMOVED THE BROKEN DEVICE OR FRAGMENTS. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICES REPORTED: FENESTRATED HELICAL BLADE (PART # 04.038.410, LOT # UNKNOWN, QUANTITY # 1), UNKNOWN LOCKING SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9871711 ↗
• InjuryMar 5, 2020Break; Break

  IT WAS REPORTED ON (B)(6) 2020, A PROXIMAL FEMORAL NAILING SYSTEM (TFNA) SHORT NAIL WITH AN INTERSECTING PROXIMAL FEMORAL NAILING SYSTEM (TFNA) HELICAL BLADE WAS BROKEN DUE TO RE-FRACTURE. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: PROXIMAL FEMORAL NAILING SYSTEM (TFNA) HELICAL BLADE (PART# 04.038.405S, LOT# H365545, QUANTITY# 1) UNKNOWN LOCKING SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1) UNKNOWN END CAP (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) TFNA NAIL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9794434 ↗
• InjuryFeb 10, 2020Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A REVISION DUE TO THE PATIENT'S FEMUR BROKE DISTAL TO A SHORT TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA) NAIL. THE TFNA NAIL , HELICAL BLADE AND DISTAL INTERLOCKING SCREW WERE ORIGINALLY IMPLANTED ON (B)(6) 2019. THE IMPLANTED DEVICES WERE REMOVED AND A LONG TFNA WAS PUT IN ITS PLACE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 9690161 ↗
• InjuryJul 29, 2019Crack; Crack

  FURTHER IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO HIP AND FEMUR PAIN ON (B)(6) 2019.

  Patient problems: No Code Available; Pain

  MAUDE report 8836695 ↗
• InjuryOct 15, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT REVISION AND HARDWARE REMOVAL OF A BROKEN TROCHANTERIC FEMORAL NAILING-ADVANCED SHORT NAIL, A TFNA SCREW AND AN UNKNOWN LOCKING SCREW DUE TO NONUNION AND DELAYED HEALING. THE BROKEN TFNA SHORT NAIL WAS REVISED WITH AN UNKNOWN LONG TFNA. THE SURGEON STATED THE PATIENT WAS DOING WELL. ON AN UNKNOWN DATE, THE PATIENT FELL ON HIS HIP AFTER BEING TRIPPED BY A CAT AND BELIEVED THIS LEAD TO THE IMPLANT FAILURE. THE DEVICES WERE ORIGINALLY IMPLANTED ON (B)(6) 2018. THERE WAS NO DELAY REPORTED DURING THE REVISION SURGERY. THE FRAGMENTS WERE REMOVED EASILY WITH NO ADDITIONAL INTERVENTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, AND PATIENT OUTCOME WAS STABLE. CONCOMITANT DEVICES: TFNA SCREW (PART # 04.038.115S, LOT # H416676, QUANTITY 1); LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN , QUANTITY 1). THIS REPORT IS FOR ONE (1) TFNA NAIL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7966325 ↗
• InjuryOct 15, 2018Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2018, A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE DUE TO A FRACTURE THAT IS NOT HEALING AND A TROCHANTERIC FEMORAL NAILING SYSTEM ADVANCE (TFNA) FEMORAL SHORT NAIL WAS BACKING OUT. A HARDWARE REMOVAL OF A TFNA HELICAL BLADE, TFNA FEMORAL SHORT NAIL STERILE AND AN UNKNOWN LOCKING SCREW WAS REMOVED AND THE TFNA NAIL WAS REPLACED WITH TOTAL HIP FROM A DIFFERENT COMPANY. ORIGINAL IMPLANT DATE IS UNKNOWN. PROCEDURE WAS COMPLETED SUCCESSFULLY, AND PATIENT OUTCOME IS STABLE. CONCOMITANT DEVICE: TFNA FENESTRATED HELICAL BLADE 100MM (PART # 04.038.400, LOT # UNKNOWN, QUANTITY 1); LOCKING SCREW (PART/LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) TFNA NAIL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7966184 ↗
• InjuryAug 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT A REMOVAL OF A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) DUE TO A FRACTURE THAT OCCURRED AT A POINT OF A STRESS RISER BETWEEN THE TFNA NAIL AND A VARIABLE ANGLE (VA) CONDYLAR PLATE. THE TFNA NAIL WAS EASILY REMOVED AND REPLACED WITH A NEW, LONGER TFNA NAIL WHICH EXTENDED BEYOND THE PLATE. AN UNKNOWN QUANTITY OF CABLES WERE ALSO PLACED TO AUGMENT THE CONSTRUCT, AS WELL AS AN UNKNOWN QUANTITY OF SCREWS. NO FRAGMENTS WERE PRODUCED. IT IS NOT KNOWN IF SURGERY WAS DELAYED. PATIENT OUTCOME IS NOT KNOWN. THIS REPORT IS FOR ONE (1) 12MM 130 DEGREE CANNULATED TFNA NAIL THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Not Applicable

  MAUDE report 7782538 ↗
• InjuryMay 17, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA), NAIL, HELICAL BLADE AND 5.0 MM DISTAL LOCKING SCREW IN (B)(6) 2017. PATIENT HAD HEALED. X-RAYS WERE TAKEN PRE-OPERATIVELY ON AN UNKNOWN DATE. PATIENT UNDERWENT HARDWARE REMOVAL ON (B)(6) 2018. DURING REVISION SURGERY IT WAS DISCOVERED THAT THE NAIL WAS BROKEN. THE NAIL HAD BROKEN PRIOR TO REMOVAL. THE NAIL HAD BROKEN JUST PROXIMAL TO THE INSERTION OF THE HELICAL BLADE. THE NAIL, HELICAL BLADE AND 5.0 MM DISTAL LOCKING SCREW WAS EASILY REMOVED. THERE WERE NO ISSUES WITH THE HELICAL BLADE OR THE LOCKING SCREW. PATIENT WAS REVISED TO A TOTAL HIP. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS REPORTED TO BE STABLE. THE EXPLANTED HARDWARE WAS DISCARDED BY THE HOSPITAL. CONCOMITANT DEVICES REPORTED: TFNA HELICAL BLADE 120 MM STERILE (PART # 04.038.320S, LOT # 981500, QUANTITY OF 1), 5.0 MM DISTAL LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY OF 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4),

  Patient problems: Failure of Implant

  MAUDE report 7522000 ↗
• InjuryApr 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A PROCEDURE TO REPAIR AN INTERTROCHANTERIC FRACTURE ON (B)(6) 2018. SURGEON WAS NAILING THE PATIENT¿S FEMUR WHEN THE BONE SPLIT. THE TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) NAIL, BLADE, AND SCREW WERE REMOVED AND REPLACED WITH A LONGER NAIL. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: TFNA HELICAL BLADE 90 MM (04.038.290S, LOT H535024, QUANTITY 1), 5.0 MM LOCKING SCREW W/T25 STARDRIVER 38 MM FOR IM NAIL (04.005.528S, LOT H485066, QUANTITY 1) . THIS REPORT IS FOR ONE (1) 12 MM 130 DEGREE TITANIUM CANNULATED TFNA NAIL 170 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7393293 ↗
• InjuryJan 17, 2018Mechanical Problem; Premature Activation; Mechanical Problem; Premature Activation

  IT WAS REPORTED THAT THE LOCKING MECHANISM INSIDE A 12X170 ADVANCED TROCHANTERIC FIXATION NAIL IS SLIGHTLY ENGAGED AND IT IS PREVENTING THE HELICAL BLADE TO SLIDE IN PROPERLY DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE HIP ON (B)(6) 2017. THE SURGEON TOOK OUT THE BLADE MULTIPLE TIMES AND REPOSITIONED IT AND THIS LED TO A SURGICAL DELAY OF 20 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE HELP OF ANOTHER READILY AVAILABLE SMALLER NAIL. THERE WAS NO HARM TO THE PATIENT. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED TO COMPLETE THE PROCEDURE. CONCOMITANT DEVICE REPORTED: UNKNOWN HELICAL BLADE (UNKNOWN PART AND LOT NUMBER, QUANTITY # 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR A NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7201258 ↗
• InjuryDec 1, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT PATIENT UNDERWENT IMPLANT PROCEDURE ON (B)(6) 2017. PATIENT WAS SCHEDULED TO UNDERGO A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) HARDWARE REMOVAL ON (B)(6) 2017 DUE TO NAIL MIGRATION MEDIALLY AND THE LAG SCREW MIGRATING INTO THE ACETABULUM. AFTER THE REMOVAL SURGERY, THE PATIENT WILL BE REVISED TO A TOTAL HIP ARTHROPLASTY. IT IS UNKNOWN IF THE REMOVAL SURGERY TOOK PLACE ON (B)(6) 2017 AS PLANNED. PATIENT OUTCOME WAS NOT REPORTED. CONCOMITANT DEVICE REPORTED: 5.0 MM TI LOCKING SCREW (PART # 04.005.528S, LOT # H260311, QUANTITY 1). THIS REPORT IS FOR ONE (1) TFNA SCREW 100MM-STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7076145 ↗

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-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
• 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