TFN-ADVANCE 04.038.000SRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10886982098344), received between Jul 17, 2019 and Sep 12, 2025 — classified as 7 injuries, 13 malfunctions.

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

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.

• InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HARDWARE REMOVAL OF RFNA AND WAS REVISED DUE TO NON-UNION.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 23038339 ↗
• MalfunctionMay 30, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ORIF SURGERY FOR TROCHANTERIC FEMORAL FRACTURE VIA THE END CAP. WHEN THE NURSE TRIED TO PASS THE END CAP TO THE SURGEON FOR INSERTING, THE HOOK WAS NOT HOOKED ENOUGH AND FELL ON THE FLOOR. SO, THE END CAP GOT UNSANITARY, THE SURGEON DECIDED TO INSERT AN END CAP(5MM) INSTEAD OF THE END CAP(0MM) IN QUESTION. THE END CAP(5MM) WAS PROTRUDED A LITTLE MORE THAN THE END CAP(0MM) WHICH WAS ORIGINALLY PLANNED TO BE USED, BUT THE INCISION WAS CLOSED BECAUSE THERE WERE NO CLINICAL PROBLEMS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22114790 ↗
• MalfunctionMay 1, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT THE OPEN OSTEOSYNTHESIS FOR TROCHANTERIC FEMORAL FRACTURE WITH THE TFNA. AT THE TIME OF INSERTING THE END CAP, THE SURGEON COMPLAINED THAT THE LOCKING MECHANISM WAS TOO HARD TO TIGHTEN AND WOULDN¿T TURN ITSELF WITH ANY EFFORT. THE INSERTING AND FIXING THE END CAP WAS EVENTUALLY SUCCEEDED, BUT THE SURGEON WAS FEELING THE METALLIC NOISE WHILE TRYING TO MAKE THE LOCKING MECHANISM DOWN OVER AND OVER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30MINS DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942982 ↗
• MalfunctionMar 21, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 07-MARCH-2024, THE PATIENT UNDERWENT AN OSTEOSYNTHESIS FOR A LEFT FEMORAL SUBTROCHANTERIC FRACTURE. DURING END CAP INSERTION, THE END CAP COULD NOT BE INSERTED FULLY, AND THE SURGEON HAD DIFFICULTY WITH INSERTION. THE SURGEON CHANGED THE DIRECTION OF THE SCREWDRIVER AND ATTEMPTED TO INSERT THE END CAP, BUT WAS UNABLE TO. THE SURGEON LOWERED THE LOCKING MECHANISM USING A FLEXIBLE SCREWDRIVER, AND WITH A TORQUE SCREWDRIVER, BUT THE END CAP COULD STILL NOT BE INSERTED FULLY. THE SURGEON DECIDED TO END THE SURGERY WITH THE END CAP AS IS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WAS NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TI END CAP FOR TFNA 0MM EXTN ¿ STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18952704 ↗
• MalfunctionMar 12, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024 THE PATIENT UNDERWENT AN ORIF SURGERY FOR A FEMORAL TROCHANTERIC FRACTURE. DURING THE PROCEDURE, THE END CAPS IN QUESTION COULD NOT BE INSERTED INTO THE NAIL. IT WAS OBSERVED THAT THE THREADS OF THE END CAPS SHOWED NO SIGN OF ENGAGING WITH THE NAIL AT ALL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TI END CAP FOR TFNA 0MM EXTN ¿ STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4)..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18884739 ↗
• MalfunctionJan 2, 2024Off-Label Use; Device-Device Incompatibility; Off-Label Use; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT ORIF SURGERY FOR AN UNKNOWN FRACTURE ON THE FEMUR WITH TFNA. DURING THE PROCEDURE, THE SURGEON HAD DIFFICULTY INSERTING THE ENDCAP IN QUESTION. THEY REPEATEDLY LOOSENED OFF THE SET SCREW AND INSERTED THE END CAP. THE SURGEON CHECKED FOR SOFT TISSUE INTRUSION BUT COULD NOT FIND ANY ISSUES. THE SURGEON WAS ABLE TO RETIGHTEN THE END CAP SO THAT IT WOULD NOT COME OFF. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 30 MINUTES. THE PATIENT OUTCOME WAS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TI END CAP FOR TFNA 0MM EXTN ¿ STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18424977 ↗
• MalfunctionOct 23, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN ORIF SURGERY FOR A FEMORAL TROCHANTERIC FRACTURE. THE SURGEON PASSED A HOOK WIRE THROUGH A SCREWDRIVER T40 AND ATTEMPTED TO INSERT THE END CAP. DURING INSERTION OF THE END CAP, A STRANGE NOISE WAS HEARD, AND THE END CAP BECAME UNABLE TO BE ADVANCED FURTHER FROM THE THREADED PART. THE SURGEON CHECKED THE LOCKING MECHANISM AND ATTEMPTED TO INSERT THE END CAP AGAIN, BUT COULD NOT. THEREFORE, THE SURGEON COMPLETED THE SURGERY WITHOUT THE END CAP. AFTER SURGERY, THE END CAP WAS CHECKED AND DAMAGE WAS FOUND ON THE THREADED PART. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF UNDER 30 MINUTES. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED, NO FRAGMENTS WERE GENERATED. THERE WAS NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A TI END CAP FOR TFNA 0MM EXTN ¿ STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17986882 ↗
• MalfunctionOct 23, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT ORIF SURGERY FOR A FEMORAL TROCHANTERIC FRACTURE WITH END CAP, TFNA SHORT NAIL AND BLADE. EVEN THOUGH THE BLADE WAS FULLY INSERTED, IT WAS ROTATED 90 DEGREES FROM NORMAL AND THE LOCKING MECHANISM DID NOT FUNCTION. THEREFORE, THE END CAP COULD NOT BE TIGHTENED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TI END CAP FOR TFNA 0MM EXTN ¿ STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17985681 ↗
• MalfunctionOct 18, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023. THE PATIENT UNDERWENT AN ORIF SURGERY FOR A FEMORAL TROCHANTERIC FRACTURE. THE SURGEON ATTEMPTED TO INSERT THE END CAP INTO A NAIL THROUGH THE HOOKED WIRE, BUT THE END CAP GOT CAUGHT IN THE THREADED PART AND COULD NOT BE INSERTED. THE SURGEON KEPT TRYING TO INSERT THE END CAP FOR ABOUT 5 MINUTES, BUT THE SURGEON WAS UNABLE TO INSERT IT. IN THE END, THE OPERATION WAS COMPLETED WITHOUT INSERTING THE END CAP. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WAS NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TI END CAP FOR TFNA 0MM EXTN ¿ STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17957727 ↗
• MalfunctionSep 28, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT ORIF SURGERY FOR FEMORAL TROCHANTERIC FRACTURE WITH TFNA END CAPS. THE SURGEON ATTEMPTED TO INSERT AN END CAP (0 MM) BUT WAS UNABLE TO DO SO. THE SURGEON CONFIRMED THAT THERE WAS NO INTERFERING SOFT TISSUE, ETC., AND ATTEMPTED TO INSERT THE END CAP (0 MM) MULTIPLE TIMES BUT WAS STILL UNABLE TO DO SO. THE SURGEON CHANGED TO AN END CAP (5 MM) AND TRIED TO INSERT IT AGAIN, BUT IT WAS STILL IMPOSSIBLE. IT WAS SUSPECTED THAT THERE WAS A PROBLEM WITH THE THREADING ON THE NAIL AND NOT THE END CAPS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES. THE PATIENT OUTCOME WAS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TI END CAP FOR TFNA 0MM EXTN - STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17835330 ↗
• MalfunctionJul 10, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)2023, THE PATIENT UNDERWENT AN UNKNOWN SURGERY FOR A TROCHANTERIC FRACTURE WITH TFNA IMPLANTS. DURING THE PROCEDURE, THE END CAP COULD NOT BE PROPERLY INSERTED. THE LOCKING MECHANISM WAS VERIFIED TO BE IN THE APPROPRIATE POSITION, AND THE END CAP WAS ENGAGED WITH THREADS OF THE NAIL, SO THE SURGEON DETERMINED THAT IT WAS ACCEPTABLE TO COMPLETE TO SURGERY. THIS REPORT IS FOR A TI END CAP FOR TFNA 0MM EXTN - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17292879 ↗
• MalfunctionApr 5, 2023Difficult to Advance; Difficult to Advance

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT OSTEOSYNTHESIS FOR FEMORAL INTERTROCHANTERIC FRACTURE WITH THE END CAP. A PHYSICIAN WITH OVER 100 CASES OF TFNA EXPERIENCE WAS IN THE ROOM AS AN ASSISTANT, AND HE TOOK OVER FOR THE PRIMARY SURGEON, BUT COULD NOT GET THE END CAP IN. THEY CHECKED AXIAL PROJECTION BUT IT WAS IN, SO THE CAUSE WAS UNKNOWN. THE SET SCREWS ARE ALSO CHECKED BY THE NIPS OF THE SCREWDRIVERS TO MAKE SURE THEY ARE DOWN. SINCE THE END CAP WAS PLACED IMMEDIATELY AFTER THE DEVICE WAS REMOVED, IT IS UNLIKELY THAT A SOFT PART INTERVENED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. CONCOMITANT DEVICE: UNKNOWN NAIL, UNKNOWN PART/LOT. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR TFNA END CAP EXTENS. 0 TAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16682810 ↗
• InjuryFeb 14, 2023Migration; Migration

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE PRIMARY SURGERY WITH THE TFNA FOR THE FEMORAL TROCHANTERIC FRACTURE. AT THE TIME OF INJURY, IT WAS P TYPE, SO THAT THE ELEVATOR WAS USED TO CHANGE TO TYPE A. THEN, IT WAS FIXED. AT ONE WEEK POSTOPERATIVELY, THE PATIENT WAS PROGRESSING WELL WITH THE EXPECTED AMOUNT OF SLIDING. APPROXIMATELY THREE MONTHS AFTER SURGERY ON (B)(6) 2023, CUT-OUT WAS CONFIRMED UNDER A TYPE. ALTHOUGH BLADE INSERTION DIRECTION WAS SLIGHTLY FORWARD, THE CAUSE OF CUT-OUT IS UNKNOWN. A REVISION SURGERY WAS SCHEDULED TO BE PERFORMED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TI END CAP FOR TFNA 0MM EXTN ¿ STERILE. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16372061 ↗
• InjuryNov 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE SURGERY FOR CERVICAL BASE FRACTURE WITH THE PRODUCTS IN QUESTION. THE PATIENT HAD BEEN ABLE TO UNDERGO AN EXTRAMEDULLARY REPAIR, BUT WAS SHIFTED TO INTRAMEDULLARY AFTER SURGERY, AND IS NOW ON THE VERGE OF AN ENDOPROSTHETIC CUTOUT. AN ARTIFICIAL HEAD REPLACEMENT WAS PERFORMED ON (B)(6) 2022. THE CAUSE IS UNKNOWN BECAUSE NO POSTOPERATIVE CT WAS TAKEN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TI END CAP FOR TFNA 0MM EXTN ¿ STERILE. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 15716597 ↗
• MalfunctionJul 22, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR TROCHANTERIC FRACTURE OF FEMUR. DURING SURGERY, THE SURGEON COULD NOT INSERT THE END CAP IN QUESTION TO A TFNA NAIL. THE SURGEON TRIED TO ADDUCT THE END CAP, MAKE THE LOCKING MECHANISM DESCEND, BUT THE SURGEON COULD NOT INSERT THE END CAP. THE SURGEON GAVE UP USING THE END CAP AND FINISHED THE PROCEDURE WITHOUT INSERTING THE END CAP. SURGICAL DELAY OF 30 MINUTES WAS NOTED. AFTER SURGERY, THE SALES REP EXAMINED IF THE END CAP COULD BE INSERTED TO A SAMPLE IMPLANT. THE END CAP COULD NOT EVEN BE INSERTED TO THE SAMPLE IMPLANT. THE THREADS ON THE END CAP DON¿T SEEM TO BE EQUAL INTERVALS, AND IT SEEMS DEFORMED. CONCOMITANT DEVICE REPORTED: UNK - NAILS: TFNA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). UNK INSERTION INSTRUMENT: TRAUMA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN END CAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15087772 ↗
• InjuryJun 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A SURGERY FOR TROCHANTERIC FRACTURE OF FEMUR. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER SURGERY, ON (B)(6) 2022, CUT-OUT OF THE BLADE AND NON-UNION WERE CONFIRMED. ON (B)(6) 2022, ALL THE IMPACTED PRODUCTS WERE EXTRACTED, AND A REVISION SURGERY WAS PERFORMED VIA BHA. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TI END CAP FOR TFNA 0MM EXTN - STERILE. THIS IS REPORT 2 OF 6 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 14830775 ↗
• InjuryJun 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT SURGERY WITH THE NAIL, END CAP, BLADE, LOCKING SCREW AND CEMENT IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. LATER, ON (B)(6) 2022 IT WAS CONFIRMED THAT PENETRATION OF THE IMPLANT OCCURRED DUE TO OSTEONECROSIS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TI END CAP FOR TFNA 0MM EXTN - STERILE. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: Necrosis

  MAUDE report 14828398 ↗
• InjuryApr 29, 2022Adverse 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) 2021, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION WITH THE TROCHANTERIC FIXATION NAIL- ADVANCED FOR THE FRACTURE OF THE DIAPHYSEAL FEMUR. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, SECONDARY FRACTURE HAD OCCURRED. A TFNA FENESTRATED HELICAL BLADE 90MM ¿ STERILE, TFNA FEMORAL NAIL Ø11 125° L200 TIMO15, LOCKSCREW Ø5 L34 F/NAILS TAN- LIGHT GREEN, AND A TFNA END CAP EXTENSION 0 TAN WERE USED DURING THE PROCEDURE. ON (B)(6) 2022, THE REVISION SURGERY WAS PERFORMED TO REMOVE THE TROCHANTERIC FIXATION NAIL- ADVANCED AND FIX THE FRACTURE WITH A LONG GAMMA NAIL AND SCREWS. ACCORDING TO THE SURGEON, THIS EVENT WAS CAUSED BY A TECHNICAL ERROR DUE TO POOR IMPLANT INSERTION POINT, NOT PRODUCT MALFUNCTION. THE SURGEON THOUGHT THAT THE PATIENT HAD NOT FALLEN. THE SURGEON GUESSED THAT THE SECONDARY FRACTURE MAY BE A STRESS FRACTURE BECAUSE THE INSERTION POINT WAS POSTERIOR, AND THE TIP OF NAIL WAS HITTING THE ANTERIOR CORTICAL BONE. NO FURTHER INFORMATION IS AVAILABLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME IS REPORTED AS S

  Patient problems: Bone Fracture(s)

  MAUDE report 14254635 ↗
• InjuryJul 30, 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 IN (B)(6) 2017, THE PATIENT UNDERWENT THE SURGERY BY USING A COMPETITORS FEMORAL IMPLANT SYSTEM IN ORDER TO PREVENT BONE FRACTURES DUE TO THE BREAST CANCER BEING SPREAD TO THE FEMUR. ON (B)(6) 2020, A REVISION SURGERY WAS PERFORMED TO REPLACE THE FEMORAL IMPLANTS DUE TO DEVICE BREAKAGE WITH SYNTHES TROCHANTERIC FIXATION NAIL ANTIROTATION (TFNA) LONG IMPLANTS. ON (B)(6) 2020, A REVISION SURGERY WAS PERFORMED DUE TO THE BREAKAGE OF THE TFNA LONG IMPLANTS. THE PATIENT WAS REVISED TO ANOTHER SET OF IMPLANTS. THERE WAS A ONE (1) HOUR SURGICAL DELAY DUE TO EXTENDED TIME IN REMOVING THE BROKEN DEVICE. IT WAS FURTHER REPORTED THE PATIENT ALSO HAD A NON-UNION WHICH MAY HAVE CONTRIBUTED TO THE DEVICE BREAKAGE. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: Impaired Healing; Nonunion/Delayed-union Bone Fracture

  MAUDE report 10343633 ↗
• MalfunctionJul 17, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2019, THE PATIENT UNDERWENT A FEMORAL TROCHANTERIC FRACTURE PROCEDURE WITH FEMORAL NAILING SYSTEM (TFNA). AT THE END OF THE PROCEDURE, THE SURGEON COULD NOT INSERT THE TFNA TITANIUM END CAP. THE SURGEON USED ANOTHER TFNA TITANIUM END CAP AND INSERTED IT SUCCESSFULLY. THE SURGEON DIDN¿T APPLY ANY EXTRA MANIPULATION, SUCH AS ADDUCTION, TO INSERT THE END CAP. THE SURGERY WAS COMPLETED WITH LESS THAN THIRTY (30) MINUTES OF SURGICAL DELAY. THE PATIENT OUTCOME WAS STABLE. CONCOMITANT DEVICE REPORTED: TROCHANTERIC FEMORAL NAILING SYSTEM (TFNA) FEMORAL NAIL (PART# 04.037.913S, LOT# UNKNOWN, QUANTITY# 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8799378 ↗

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-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-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-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