TFN-ADVANCE 04.037.142SRecalls & reported problems
Synthes GmbH · 11MM/130 DEG TI CANN TFNA 170MM - STERILE · Class 2 · Implant
All models of TFN-ADVANCE (195)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Synthes TFNA titanium cannulated nail, an intramedullary rod used to fix hip fractures. The 44 reports mostly describe the nail or its parts breaking during or after surgery, bolts that would not connect or release from the aiming arm so the nail could not be removed, and the nail migrating or cutting out of the bone, sometimes leaving the bone unhealed and needing a second operation. Reports mention 29 injuries and no deaths. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 44
- Deaths reported
- 0
- Injuries reported
- 29
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10886982096548), received between Jan 16, 2018 and Oct 22, 2025 — classified as 29 injuries, 15 malfunctions.
The most frequently reported specific device problem is “Break” (12 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem12
- Break12
- Device-Device Incompatibility10
- Migration6
- Device Contaminated During Manufacture or Shipping1
- Device Difficult to Maintain1
- Device Handling Problem1
- Improper or Incorrect Procedure or Method1
Patient problems
- No Code Available8
- No Clinical Signs, Symptoms or Conditions7
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- No Consequences Or Impact To Patient4
- Pain4
- Bone Fracture(s)3
- Insufficient Information3
- Nonunion/Delayed-union Bone Fracture3
Recent adverse event reports
The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 22, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED ON (B)(6) 2025 THAT THE CONNECTING BOLT BELIEVED TO BE COLD WELDED ON THE NAIL AND WAS UNABLE TO REMOVE THE NAIL FROM THE AIMING ARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23358201 ↗MalfunctionSep 18, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE TFNA WOULD NOT CONNECT TO THE AIMING ARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23084486 ↗InjuryMay 30, 2025Migration; Migration
IT WAS REPORTED THAT THE PATIENT HAS A SHORT TFNA NAIL THAT FAILED POSTOPERATIVELY. THE NAIL HAD STARTED TO COLLAPSE. PATIENT EXPERIENCED NONUNION, AND UNKNOWN ADDITIONAL INTERVENTION WAS REQUIRED.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 22117050 ↗InjuryApr 23, 2025Migration; Migration
IT WAS REPORTED THAT TFNA CUT OUT AND PATIENT WAS REVISED TO THA.
Patient problems: Insufficient Information
MAUDE report 21892496 ↗InjuryOct 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE THERE HAS BEEN A SURGICAL SITE INFECTION AT THE HOSPITAL INVOLVING DEPUY SYNTHES DEVICES THAT WERE INVOLVED IN A HIP NAILING WITH NO FURTHER INFORMATION PROVIDED AT THIS TIME.
Patient problems: Unspecified Infection
MAUDE report 20485235 ↗InjuryMar 7, 2024Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE TFNA IMPLANT IN A PATIENT IS BROKEN . IT HAD TO BE REMOVED AND REPLACED. IT IS UNKNOWN WHEN THE ISSUE WAS DISCOVERED. PROCEDURE AND PATIENT WAS REVISED TO LONG TFNA. THIS REPORT INVOLVES (1) 11MM/130 DEG TI CANN TFNA 170MM - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 18859883 ↗InjuryDec 21, 2023Migration; Migration
IT WAS REPORTED THAT ON (B)(6) 2023, A HARDWARE REMOVAL PROCEDURE FOR A HIP NAIL WAS PERFORMED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN 11MM/130 DEG TI CANN TFNA 170MM ¿ STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 18378367 ↗MalfunctionAug 8, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT PRIOR TO A PROCEDURE ON (B)(6) 2023, THE CIRCULATING NURSE OPENED THE PACKAGING OF THE NAIL IN QUESTION AND FOUND A STRING-LIKE ARTIFACT INSIDE. THE SURGEON AND SALES REP WERE NOTIFIED, AND A NEW NAIL WAS OPENED FOR USE IN THE PROCEDURE. THERE WAS NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN 11MM/130 DEG TI CANN TFNA 170MM ¿ STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17479621 ↗InjuryFeb 7, 2023Break; Break
IT WAS REPORTED THAT A FOLLOW-UP X-RAY REVEALED A BROKEN BLADE AND TFNA NAIL. SURGERY TO IMPLANT THE DEVICES OCCURRED ON (B)(6) 2022. SURGERY WENT WELL AND PATIENT WAS DOING FINE, THEN SHOWED UP WITH A BROKEN LAG SCREW APPROXIMATELY IN (B)(6). PATIENT DID REPORT A FALL. PAIN CAME ON SUDDENLY AND PATIENT FELT LIKE SHE BROKE HER HIP AGAIN. X-RAYS REVEALED LAG SCREW BROKE. REVISION SURGERY OCCURRED ON (B)(6) 2023 WITH A TOTAL HIP ARTHROPLASTY. THE PROCEDURE WENT WELL AND ALL IMPLANTS WERE RECOVERED.
Patient problems: Failure of Implant; Pain
MAUDE report 16311080 ↗InjuryJun 3, 2022Break; Break
IT WAS REPORTED A PATIENT PRESENTED WITH HIP PAIN. RADIOGRAPHS WERE TAKEN ON AN UNKNOWN DATE WHERE IT WAS OBSERVED THAT A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL HAD BROKEN. THE NAIL HAD BROKEN APPROXIMATELY, TO THE POINT WHERE THE HELICAL BLADE PASSES THROUGH THE NAIL. REVISION SURGERY WAS COMPLETED ON A UNKNOWN DATE IN (B)(6) 2022 WHERE ALL HARDWARE WAS REMOVED AND THE PATIENT WAS REVISED TO A HEMIARTHROPLASTY OF THE LEFT HIP. NO FRAGMENTS WERE RETAINED, ALL PIECES WERE REMOVED. THE TFNA WAS ORIGINALLY IMPLANTED ON AN UNKNOWN DATE IN (B)(6) 2022. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR A TFNA NAIL.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 14597214 ↗InjuryMay 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2022 A REVISION SURGERY OCCURRED FOR REMOVAL TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) CONSTRUCT. PATIENT WAS REVISED TO TOTAL HIP ARTHROPLASTY. NO SURGICAL DELAY. PROCEDURE COMPLETED SUCCESSFULLY. ORIGINAL IMPLANT DATE UNKNOWN. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT IS FOR A TFNA NAIL.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 14464270 ↗InjuryMar 29, 2022Migration; Migration
IT WAS REPORTED THAT ON (B)(6) 2022, THE TFNA HARDWARE WAS REMOVED DUE TO THE IMPLANT FAILING. THE IMPLANT HAD CUT THROUGH AND HAD CREATED AN ULCER ON THE PATIENT¿S LATERAL SIDE. THE IMPLANT WAS INTACT AND NO FRAGMENTS WERE CREATED. THE PATIENT WAS REVISED WITH A TOTAL HIP ARTHROPLASTY (THA). THIS REPORT INVOLVES ONE (1) 9MM/130 DEG TI CANN TFNA 235MM/LEFT - STERILE. THIS IS REPORT 2 OF 3 FOR (B)(4).
Patient problems: Ulcer
MAUDE report 13940100 ↗InjuryMar 9, 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 SURGEON REMOVED ONE (1) TFNA SHORT NAIL, ONE (1) TFNA SCREW, AND ONE (1) 5.0 TITANIUM LOCKING SCREW WITH T25 STARDRIVE RECESS. THE PATIENT WAS INFECTED AND THE HARDWARE HAD TO BE REMOVED. EVERYTHING WAS REMOVED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) 11MM/130 DEG TI CANN TFNA 170MM - STERILE. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).
Patient problems: Unspecified Infection
MAUDE report 13713903 ↗InjuryFeb 11, 2022Migration; Migration
IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT REMOVAL SURGERY OF THE TFNA IMPLANTS IN QUESTION. AFTER THE IMPLANTS WERE REMOVED, IT WAS FOUND THAT THE UNKNOWN LAG SCREW WAS NOT LOCKED DURING IMPLANTATION AND THIS ALLOWED THE SCREW TO MIGRATE. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) 11MM/130 DEG TI CANN TFNA 170MM - STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 13516906 ↗InjuryJul 20, 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 REVISION SURGERY BECAUSE WHILE AT A FACILITY WHILE TRANSFERRING BEDS, THE PATIENT WAS DROPPED, RESULTING IN ANOTHER FRACTURE. 11MM/130 DEG TI CANN PROXIMAL FEMORAL NAILING SYSTEM (TFNA), TFNA FENESTRATED SCREW, AND 5.0MM TI LOCKING SCREW WERE REMOVED. THEY WERE NOT BROKEN; THEY WERE IN PLACE. THE TFNA WAS REMOVED AND EXCHANGED FOR A LONGER NAIL. THERE WAS NO INFECTION OR BROKEN IMPLANTS. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1)11/130 DEG TI CANN TFNA 170 - STERILE. THIS REPORT IS 1 OF 3 FOR (B)(4).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12198745 ↗MalfunctionApr 20, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2021, AFTER PLACING LAG SCREW FOR TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA), THE SURGEON ATTEMPTED TO LOCK LAG SCREW IN FOR ROTATIONAL STABILITY USING THE FLEXIBLE HEX DRIVER AND WAS UNABLE TO LOCK IT DOWN. SURGEON REMOVED NAIL AND LAG SCREW AND USED A NEW NAIL. THE SURGERY WAS DELAYED FOR TEN (10) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 11MM/130 DEG TI CANN TFNA 170MM - STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11697284 ↗InjuryApr 15, 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 A HARDWARE REMOVAL OF THE TROCHANTERIC FIXATION NAIL ADVANCED FROM THE PATIENT'S RIGHT HIP. BASED ON XRAYS IT WAS DETERMINED THE HELICAL BLADE WAS CUTTING THROUGH THE FEMORAL HEAD. THE PATIENT'S INTERTROCHANTERIC FRACTURE WAS HEALED. THE ORIGINAL IMPLANT WAS ON (B)(6) 2020. THE HARDWARE REMOVAL WAS SUCCESSFULLY COMPLETED WITHOUT DELAY. NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) 11/130 DEG TI CANN TFNA 170 - STERILE. THIS REPORT IS 1 OF 3 FOR (B)(4).
Patient problems: Bone Fracture(s)
MAUDE report 11675654 ↗MalfunctionApr 8, 2021Migration; Migration
IT WAS REPORTED THAT ON (B)(4) 2021, THE PATIENT UNDERWENT A REVISION OF TROCHANTERIC FIXATION NAIL ADVANCED (TFNA ) CONVERSION TO TOTAL HIP. TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) WAS REMOVED DUE TO CUT OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) 11/130 DEG TI CANN TFNA 170 - STERILE. THIS IS REPORT 2 OF 3 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11633926 ↗InjuryApr 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED ON (B)(6) 2021, PATIENT UNDERWENT REMOVAL OF PROXIMAL FEMORAL NAILING SYSTEM (TFNA) NAIL, TFNA HELICAL BLADE AND UNKNOWN LOCKING SCREW FOR TOTAL HIP REPLACEMENT. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) TFNA FENESTRATED HELICAL BLADE 95MM. THIS REPORT IS 2 OF 3 (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11616687 ↗MalfunctionFeb 3, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE IN 2021, THE HELICAL BLADE WAS NOT ADVANCING COMPLETELY THROUGH THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) SHORT NAIL 170MM AND WAS NOT ABLE TO BE EXTRACTED EASILY. HARDWARE WAS ABLE TO BE COMPLETELY REMOVED AND NEW HARDWARE WAS IMPLANTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A 11MM/130 DEGREE TITANIUM (TI) CANN TFNA NAIL. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11274747 ↗InjuryMay 1, 2020Break; Break
IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REMOVAL/REVISION OF A BROKEN PROXIMAL FEMORAL NAILING SYSTEM (TFNA). THE PATIENT PRESENTED WITH FOLLOW UP X-RAYS THAT SHOWED THE PROXIMAL FEMORAL NAILING SYSTEM (TFNA) TITANIUM SCREW BACKED UP AND THE FEMORAL HEAD ROTATED. DURING REVISION, IT WAS FOUND THAT THE LOCKING GATE WAS BROKEN INSIDE THE PROXIMAL FEMORAL NAILING SYSTEM (TFNA) SHORT NAIL BROKE. THERE WERE FRAGMENTS GENERATED FROM THE BROKEN DEVICE BUT EVERYTHING WAS REMOVED WITHOUT A PROBLEM. THE PROCEDURE OUTCOME IS UNKNOWN. THE PATIENT'S OUTCOME WAS A STABLE REVISION. CONCOMITANT DEVICE REPORTED: UNKNOWN LOCKING SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1); UNKNOWN END CAP: TFNA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS ONE (1) 11MM/130 DEG TI CANN TFNA 170MM - STERILE. THIS REPORT IS 2 OF 2 FOR (B)(4).
Patient problems: No Code Available
MAUDE report 10018218 ↗InjuryApr 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2020, PATIENT UNDERWENT REMOVAL OF ONE (1) TITANIUM CANNULATED PROXIMAL FEMORAL NAILING SYSTEM (TFNA), ONE (1) TITANIUM LOCKING SCREW, ONE (1) TFNA HELICAL BLADE AND ONE (1) TFNA END CAP BECAUSE THE FEMUR BROKE BELOW WHERE THESE IMPLANTS SAT. IMPLANTS WERE ORIGINALLY IMPLANTED ON (B)(6) 2020. SHE WAS INITIALLY SEEN FOR AN INTERTROCHANTERIC HIP FRACTURE. ALL IMPLANTS ARE SUCCESSFULLY REMOVED AND WERE REVISED TO A LONG TFNA AND WERE ALSO AUGMENTED FIXATION WITH A TRAUMA CEMENT. THE PATIENT OUTCOME WAS SUCCESSFUL WITH NO CONCERNS. CONCOMITANT DEVICES REPORTED: 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM FOR IM NAILS (PART NUMBER 04.005.524, LOT UNKNOWN, QUANTITY 1), TFNA HELICAL BLADE 90MM ( PART NUMBER 04.038.290, LOT UNKNOWN, QUANTITY 1), END CAPS: TFNA ( UNKNOWN PART NUMBER, UNKNOWN LOT, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 11MM/130 DEG TI CANN TFNA 170MM ¿ STERILE. THIS IS REPORT 1 OF 4 FOR (B)(4).
Patient problems: Bone Fracture(s); No Code Available
MAUDE report 9953379 ↗InjuryMar 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT UNDERWENT REMOVAL OF A SHORT TROCHANTERIC FEMORAL NAIL (TFNA) ON (B)(6) 2020. THE PATIENT SUSTAINED A DISTAL THIRD FEMUR FRACTURE. ALL IMPLANTS WERE SUCCESSFULLY EXPLANTED WITHOUT ISSUE AND THE PATIENT WAS REVISED WITH A STRYKER NAIL. NO PATIENT CONSEQUENCES REPORTED. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS IS 1 OF 4 FOR REPORT (B)(4).
Patient problems: Bone Fracture(s)
MAUDE report 9824597 ↗MalfunctionJan 13, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE RIGHT FEMUR ON (B)(6) 2019, THE LOCKING MECHANISM OF A TROCHANTERIC FEMORAL NAILING SYSTEM ADVANCED (TFNA) NAIL WOULD NOT MOVE AT ALL WHEN THE SURGEON WENT TO ENGAGE IT. THE ISSUE HAPPENED AFTER THE NAIL AND SAME HELICAL BLADE (95MM) WAS INSERTED. THE NAIL WAS THEN REMOVED AND TESTED, AND IT STILL WOULDN'T MOVE. THUS, ANOTHER NAIL WAS OPENED. THERE WAS A SURGICAL DELAY OF 20 MINUTES. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICES REPORTED: UNKNOWN TFNA HELICAL BLADE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1), UNKNOWN SCREWDRIVER SHAFT( PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1), UNKNOWN TORQUE LIMITING ATTACHMENT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1), UNKNOWN T-HANDLE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN), UNKNOWN INSERTION HANDLE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9582819 ↗InjurySep 13, 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 REMOVAL OF TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) DUE TO A NON-UNION OF THE INTERTROCHANTERIC FEMUR FRACTURE. THE SURGEON SUCCESSFULLY REMOVED THE HARDWARE AND REPLACED THE DEVICE TO A DYNAMIC CONDYLAR SCREW (DCS) AND 95 DEG DCS PLATE 8 HOLE WITH AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) PROCEDURE OF RIGHT FEMUR. PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 1 OF 3 FOR (B)(4).
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 9034638 ↗
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, ClassifiedTFNA 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, ClassifiedTFNA 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, ClassifiedTFN-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, ClassifiedTFN-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, ClassifiedTFN-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 · TerminatedSynthes 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 · TerminatedHelical 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 · TerminatedTFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
- Z-1352-2015 · Feb 24, 2015 · TerminatedSynthes 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
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- TRIGEN 71674067Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES201 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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