TFN-ADVANCE 04.037.160SRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10886982096685), received between Sep 1, 2016 and Feb 16, 2022 — classified as 17 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 16, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PROXIMAL FEMORAL NAILING SYSTEM (TFNA) NAIL WAS BROKEN. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE 11/130 DEG TI CANN TFNA 400/RIGHT - SILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13544430 ↗
• InjuryDec 15, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA) ON AN UNKNOWN DATE IN (B)(6) 2021. TFNA NAIL BROKE POST-OPERATIVELY AT THE JUNCTION OF THE NAIL AND THE LAG SCREW. THE REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2021 WITH REMOVAL OF TFNA AND INSERTION OF TROCHANTERIC FIXATION NAIL (TFN). PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 11MM/130 DEG TI CANN TFNA 400MM/RIGHT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

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

  MAUDE report 13011296 ↗
• InjuryOct 21, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT REMOVAL SURGERY DUE TO A BROKEN TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL. NO FURTHER COMPLICATION TO THE PATIENT AND THE NAIL WAS IMPLANTED SHORTLY AFTER. THE PROCEDURE OUTCOME AND PATIENT'S STATUS ARE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - NAIL HEAD ELEM: TFNA HELICAL BLADE (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1). UNK - SCREWS: LOCKING: TRAUMA (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR (1) 11MM/130 DEG TI CANN TFNA 400MM/RIGHT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12674177 ↗
• InjuryDec 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT WENT ON TO A NON-UNION THAT CAUSED THE IMPLANTS TO FAIL. THE ORIGINAL DATE OF IMPLANTATION WAS ON (B)(6) 2020. ALL IMPLANTS WERE REMOVED SUCCESSFULLY AND REPLACED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS GOOD. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) 11MM/130 DEG TI CANN TFNA 400MM/RIGHT - STERILE. THIS REPORT IS 1 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11012977 ↗
• MalfunctionSep 18, 2020Break; Break

  IT WAS REPORTED ON (B)(6) 2020, A PROXIMAL FEMORAL NAILING SYSTEM (TFNA) NAIL BROKE. THERE WERE FRAGMENTS GENERATED AND ALL BROKEN AND DAMAGED PIECES TO THE DEVICE WERE REMOVED WITHOUT DIFFICULTY OR ADDITIONAL INTERVENTION. THE BROKEN TFNA NAIL WAS REMOVED AND WAS REVISED WITH 4.5 LCP PROXIMAL FEMUR PLATE. THE PATIENT WAS DOING WELL. CONCOMITANT DEVICE REPORTED: UNKNOWN TFNA HELICAL BLADE (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1); UNKNOWN LOCKING SCREW (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 11MM/130 DEG TI CANN TFNA 400MM/RIGHT - STERILE. THIS IS REPORT 1 OF 1 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10554337 ↗
• InjurySep 10, 2020Break; Break

  THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER MW5095765. THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10515676 ↗
• InjuryAug 13, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TFNA NAIL WAS BROKEN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK- HELICAL BLADE (PART # UNKNOWN; LOT # UNKNOWN; QUANTITY: UNKNOWN), UNK - SCREWS: LOCKING (PART # UNKNOWN; LOT # UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) 11MM/130 DEG TI CANN TFNA 400MM/RIGHT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10404200 ↗
• InjuryMar 19, 2020Break; Break

  IT WAS REPORTED THAT (B)(6) 2020, THE PATIENT UNDERWENT A REVISION OF A BROKEN PROXIMAL FEMORAL NAILING SYSTEM (TFNA). FRAGMENTS WERE GENERATED AND WERE REMOVED EASILY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN LAG SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN DISTAL LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 11MM/ 130 DEG TI CANN TFNA 400MM/ RIGHT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9856023 ↗
• InjuryDec 18, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE TFNA LONG BROKEN IN HALF AT TAPER JUNCTION-BELOW THE HELICAL BLADE. PATIENT HAD REVISION SURGERY FOR HARDWARE REMOVAL. PATIENT EXPERIENCING POST-OPERATIVE COMPLICATIONS. CONCOMITANT DEVICES REPORTED: UNKNOWN LOCKING SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN) UNKNOWN NAIL HEAD ELEMENTS: TFNA HELICAL BLADE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; Injury; No Code Available

  MAUDE report 9490461 ↗
• InjuryNov 5, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO NONUNION AND BROKEN TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) NAIL. X-RAYS TAKEN ON AN UNKNOWN DATE SHOWED NON-UNION AND BROKEN NAIL. ORIGINALLY, THE PATIENT WAS IMPLANTED WITH A PROXIMAL FEMORAL NAILING SYSTEM ON AN UNKNOWN DATE. THE IMPLANT WAS REMOVED AND SUBSEQUENT NEW FEMORAL RECON NAIL (FRN) PERFORMANCE NAIL WAS IMPLANTED. PATIENT IS SEEMINGLY FINE, FRACTURE WAS REAMED AND REDUCED. CONCOMITANT DEVICE REPORTED: UNKNOWN TFNA HELICAL BLADE ( PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). UNKNOWN LOCKING SCREW ( PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). UNKNOWN TFNA END CAP ( PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 11MM/130 DEG TI CANN TFNA 400MM/RIGHT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 9282453 ↗
• InjuryOct 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO NON-UNION. THE PATIENT WAS ORIGINALLY IMPLANTED WITH A TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) SYSTEM ON AN UNKNOWN DATE. THE SURGEON REMOVED THE 130 DEGREES RIGHT ANGLE TFNA NAIL AND THE TFNA LAG/ FENESTRATED SCREW. THERE WAS NO SURGICAL DELAY. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH A 95 DEGREE CONDYLAR BLADE PLATE. THE PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) 11MM/130 DEG TI CANN TFNA 400MM/RIGHT - STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 9144995 ↗
• InjurySep 20, 2019Break; Break

  IT WAS REPORTED ON AUGUST 23, 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL OF A TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) LAG SCREW AND NAIL, WHILE A TOTAL HIP PROSTHESIS WAS BEING PERFORMED. INITIALLY, THE PATIENT HAD A HIP FRACTURE FIXED WITH A TFNA NAIL ON (B)(6) 2017, BY ANOTHER SURGEON. THE FRACTURE HEALED BUT THE PATIENT'S LEG WAS SHORT AND HAD TROUBLE WALKING, SO THE SURGEON OPTED TO PERFORM A TOTAL HIP PROCEDURE. UPON REVIEW OF THE X RAYS BEFORE THE START OF THE PROCEDURE ON (B)(6) 2019, IT WAS NOTICED THAT THE TFNA NAIL WAS BROKEN. THE SURGEON REMOVED THE LAG SCREW AND BROKEN TFNA NAIL SUCCESSFULLY WITH AN EXTRACTION HOOK AND REMOVAL INSTRUMENTS. THE PROCEDURE TOOK APPROXIMATELY TWENTY-FIVE TO THIRTY (25-30) MINUTES. THE SURGEON THEN PROCEEDED TO PERFORM THE TOTAL HIP PROCEDURE. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN TFNA LAG SCREW (PART#/LOT# UNKNOWN, QUANTITY 1), UNKNOWN LOCKING SCREWS (PART#/LOT#/QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 11 MM/130 DEG TI CANN TFNA 400 MM/RIGHT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9100470 ↗
• InjuryMay 23, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SURGEON REMOVED THE TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) NAIL-STERILE DUE TO FEMORAL HEAD FELL INTO VARUS AND THE TFNA NAIL BROKE AT THE JUNCTION RIGHT BELOW THE UNKNOWN HELICAL BLADE. AN UNKNOWN NAIL WAS USED INSTEAD. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN HELICAL BLADE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1), UNKNOWN TFNA SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN). THIS REPORT IS FOR ONE (1) 11MM/130 DEG TI CANN TFNA 400MM/RIGHT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 8637424 ↗
• MalfunctionApr 17, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) PROCEDURE, THE NURSE HANDED THE TFNA NAIL TO THE SCRUB TECHNICIAN, THE NAIL WAS ATTACHED TO THE CONNECTING UNKNOWN SCREW AND THE UNKNOWN INSERTION HANDLE. THE SCRUB TECHNICIAN MISTAKENLY USED THE 5MM FLEXIBLE DRIVER TO CONNECT THE TFNA NAIL TO THE INSERTION JIG INSTEAD OF CORRECTLY USING THE 8MM HEX DRIVER WITH A CONNECTING SCREW. THE TFNA NAIL WAS INSERTED. DURING THE HELICAL BLADE INSERTION, A PORTION OF THE TFNA SYSTEM, THE BLADE BECAME LODGED HALFWAY INTO THE NAIL. AFTER MULTIPLE EXTRACTION TECHNIQUES, THE BLADE WAS SUCCESSFULLY REMOVED AND THE NAIL FOLLOWED. AFTER EXAMINING THE IMPLANTS AND SEEING THE DAMAGE, THE DOCTOR ASKED FOR A NEW TFNA NAIL AND TFNA BLADE. THERE WERE 20 MINUTES OF SURGICAL DELAY. PROCEDURE ENDED SUCCESSFULLY. PATIENT OUTCOME WAS SUCCESSFUL. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY 1) UNKNOWN NAIL INSERTION HANDLES (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY 1) UNKNOWN FLEXIBLE DRIVER (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY 1) THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) 11MM/130 DEG TI CANN TFNA 400MM/RIGHT -

  Patient problems: No Patient Involvement

  MAUDE report 8525085 ↗
• InjuryMar 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A REVISION OF OPEN REDUCTION AND INTERNAL FIXATION (ORIF) WITH ANTEGRADE FEMORAL NAIL TO A RIGHT CLOSED COMMINUTED SUBTROCHANTERIC FEMUR FRACTURE. THE PATIENT HAD A NONUNION WHICH RESULTED IN A FAILED IMPLANT (PROXIMAL PORTION OF THE NAIL HAD FRACTURED) AS WELL AS PAIN AND INABILITY TO BEAR WEIGHT. THE PATIENT WAS INSERTED WITH A NEW IMPLANT. IT WAS SECURED WITH A COMPRESSION SCREW AND A LAG SCREW SET IN STATIC POSITION. TWO DISTAL INTERLOCKING SCREWS WERE ALSO PLACED INTO LOCKING POSITION. THE SURGEON REMOVED THE PROXIMAL PORTION OF THE NAIL WHICH HAD FRACTURED. THEN USED THE CROSS STARTING DEVICE TO REMOVE THE HELICAL BLADE THROUGH A SEPARATE INCISION, RECANNULATED THE PATIENTS REMAINING PORTIONS OF THE NAIL DISTALLY, REMOVED THE DISTAL INTERLOCKING SCREW, AND THEN USED A HOOK TO BALL TIP GUIDEWIRE TO HOOK ON TO THE DISTAL PORTION OF THE NAIL AND THEN MALLET IT OUT. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICES REPORTED: TFNA HELICAL BLADE (PART 04.038.310S, LOT H383442, QUANTITY 1); UNKNOWN INTERLOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1); 2.5MM REAMING ROD WITH BALL

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 8466767 ↗
• InjuryAug 1, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL REMOVAL ON (B)(6) 2018, DUE TO A BROKEN NAIL AND TO REDUCE THE NON-UNION. ORIGINALLY, THE TFNA NAIL WAS IMPLANTED ON OCTOBER 2017 TO TREAT A PATHOLOGIC FRACTURE AND AFTER SEVEN MONTHS, THE PATIENT HAD A NON-UNION. THE SURGEONS REMOVED THE BROKEN NAIL TO REDUCE THE NON-UNION INTO A BETTER POSITION AND REINSERTED A COMPETITOR¿S INTERTROCHANTERIC ANTEGRADE NAIL. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO PATIENT OUTCOME REPORTED. CONCOMITANT DEVICES REPORTED: TFNA HELICAL BLADE (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1); DISTAL LOCKING SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 11MM 130 DEGREE TFNA NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Not Applicable

  MAUDE report 7740644 ↗
• InjuryMay 1, 2018Break; Break

  IT WAS REPORTED PATIENT WAS IMPLANTED WITH THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL, A TFNA HELICAL BLADE, AND A 5.0MM LOCKING SCREW ON (B)(6) 2017. A NON-UNION WAS DISCOVERED ON UNKNOWN DATE. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE SURGEON REMOVED ALL HARDWARE. DURING THE REVISION SURGERY, IT WAS NOTED THAT THE TFNA NAIL WAS BROKEN IN HALF, MAKING REMOVAL DIFFICULT. THE HELICAL BLADE AND LOCKING SCREW WERE REMOVED INTACT. PATIENT WAS THEN REVISED TO A DYNAMIC HIP SCREW (DHS). SURGERY WAS COMPLETED WITH NO DELAY. PATIENT REPORTED IN GOOD CONDITION. CONCOMITANT DEVICES REPORTED: TFNA HELICAL BLADE 100MM (PART 04.038.300S, LOT H286485, QUANTITY 1); 5.0MM LOCKING SCREW 40MM FOR IM NAILS (04.005.530, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 11MM 130 DEGREE CANNULATED TFNA NAIL 400MM RIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7478159 ↗
• InjuryMar 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD TO UNDERGO A REVISION ORIF SURGERY ON (B)(6) 2018 DUE TO NON-UNION. INITIALLY THE PATIENT HAD AN ORIF OF SUBTROCHANTERIC FEMUR FRACTURE WHICH WAS FIXED WITH A SYNTHES TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) SCREW 95MM, 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM FOR IM NAILS AND 11MM/130 DEG TI CANN TFNA 400MM/RIGHT - STERILE ON AN UNKNOWN DATE. DURING THE REVISION SURGERY ONE (1) TFNA SCREW 95MM, ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM FOR IM NAILS AND ONE (1) 11MM/130 DEG TI CANN TFNA 400MM/RIGHT - STERILE WERE ALL REMOVED SUCCESSFULLY AND WERE NOT BROKEN. THE PATIENT WAS IMPLANTED WITH A SYNTHES DYNAMIC HIP SCREW SYSTEM (DHS) PLATE, LARGE SCREW AND CORTEX SCREWS TO ADDRESS THE NON-UNION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY DELAY. THE PATIENT WAS STABLE AFTER THE SURGERY. THIS REPORT IS FOR ONE (1) 11MM 130 DEGREE CANNULATED TFNA 400MM. (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7363662 ↗
• MalfunctionDec 5, 2017Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT DURING AN INTRAMEDULLARY (IM) NAILING OF A TROCHANTERIC FRACTURE OF A HIP USING A TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA) ON (B)(6) 2017, A METAL FRAGMENT WAS SEEN ON THE X-RAY IMAGE AFTER DRILLING, BUT BEFORE HELICAL BLADE INSERTION. DRILLING FOR THE HELICAL BLADE PLACEMENT WAS SMOOTH AND THE SURGEON EXPERIENCED NO ISSUES AND DID NOT HAVE ANY RESISTANCE. TO THE SURGEON¿S KNOWLEDGE HE DID NOT HIT THE NAIL WITH THE DRILL BIT DURING DRILLING. AFTER HE REMOVED THE DRILL BIT AND BEFORE HELICAL BLADE PLACEMENT AN INTRAOPERATIVE X-RAY WAS TAKEN WHICH REVEALED A METAL FRAGMENT. THE SURGEON WAS NOT SURE WHERE IT CAME FROM. THE X-RAY IMAGE WAS NOT SAVED AND IS NOT AVAILABLE FOR REVIEW. THE SURGEON DID NOT ATTEMPT TO REMOVE THE FRAGMENT, AS IT WAS NOT A CONCERN FOR PATIENT¿S HARM. THE SURGEON DID INSPECT THE DRILL BIT AND THERE WAS NO VISIBLE DAMAGE NOTED TO THE DRILL BIT. AFTER THE HELICAL BLADE INSERTION, THE NAIL SET SCREW WAS ABLE TO BE TURNED A QUARTER OF A TURN TO LOCK THE HELICAL BLADE IN PLACE AND AGAIN THIS WAS PERFORMED WITHOUT INCIDENT. THERE WAS A LATER X-RAY TAKEN BUT DUE TO THE ANGLE OF THE IMAGE THE FRAGMENT IS NOT VISIBLE. PROCEDURE COMPLETED SUCCESSFU

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7082488 ↗
• InjurySep 1, 2016Fracture; Fracture

  SIX WEEKS POST A INTRAMEDULLARY MAILING FOR A RIGHT SUBTROCHANTERIC FEMUR FRACTURE PATIENT FELT A SUDDEN PAIN IN RIGHT HIP WHILE WALKING. UPON EXAMINATION HE WAS NOTED TO HAVE FAILURE OF HIS HARDWARE PROXIMALLY WITH THE NAIL APPEARING TO HAVE BROKEN WHERE THE HELICAL BLADE PASSES THROUGH IT.

  Patient problems: Pain

  MAUDE report 5956296 ↗

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-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-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-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