TFN-ADVANCE 04.038.390SRecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10886982099259), received between Jul 3, 2018 and Mar 24, 2026 — classified as 16 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Migration” (14 reports).

2 other recalls cover devices cleared under the same FDA submission (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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2026Device-Device Incompatibility

  DURING THE SURGERY, THE HELICAL BLADE SLID ALONG THE 3.2MM THREADED PIN, BUT IT STOPPED HALFWAY AND WOULDN'T MOVE FORWARD OR BACKWARD. THE SYSTEM WAS DISASSEMBLED. THE BLADE GOT STUCK WITH THE SCREWDRIVER AND WOULDN'T COME OUT. A NEW IMPLANT OF THE SAME LENGTH WAS USED WITHOUT ANY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24672832 ↗
• MalfunctionJun 6, 2025Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT UNKNOWN SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. IT APPEARS THAT EXCESSIVE COMPRESSION HAD BEEN APPLIED DURING THE INITIAL SURGERY AND STRESS HAD BEEN PUT ON THE LATERAL WALL, CAUSING IT TO CRACK. THE AFFECTED AREA APPEARS TO HAVE BECOME MORE UNSTABLE SINCE THE INITIAL SURGERY. THE LOCKING MECHANISM HAD ALSO BEEN SET IN A SLIDING POSITION, WHICH RESULTED IN A BONE-TO-NAIL SITUATION, WITH THE BLADE MOVING IN THE DIRECTION OF CUTTING OUT. THE TREATMENT PLAN IS THAT THE DISLOCATION DOES NOT APPEAR TO HAVE PROGRESSED OVER THE PAST WEEK FROM THE ALERT DATE, SO THE SURGEON WILL MONITOR THE SITUATION WITH TERIPARATIDE FOR TWO WEEKS.

  Patient problems: Bone Notching

  MAUDE report 22160257 ↗
• MalfunctionMay 29, 2025Material Twisted/Bent; Migration; Material Twisted/Bent; Migration

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE INSERTER WORKED FINE AFTER THE CASE. IT SEEMS THE INSERTER AND HELICAL BLADE GO CROSS THREADED ON THE INSERTER.

  Patient problems: Bone Notching; Unspecified Tissue Injury

  MAUDE report 22104116 ↗
• InjuryMar 25, 2024Migration; Migration

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN ORIF WITH A TFNA IMPLANT FOR A FEMORAL TRANSVERSE FRACTURE. ON THE DAY OF THE SURGERY, 4 PARTS WERE TREATED, BUT AGMT CEMENT WAS NOT USED AT THE SURGEON¿S DISCRETION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. ON (B)(6) 2024, ROTATIONAL DEFORMATION WAS DISCOVERED. THE PATIENT¿S CONDITION WAS OBSERVED, ON (B)(6) 2024 A BLADE WAS DISCOVERED TO BE CUT-OUT. A REVISION PROCEDURE WAS SCHEDULED TO BE PERFORMED ON (B)(6) 2024. THE PATIENT¿S STATUS IS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TFNA FENESTRATED HELICAL BLADE 90MM - STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18969893 ↗
• MalfunctionMar 5, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN ORIF SURGERY FOR THE LEFT FEMORAL TROCHANTERIC FRACTURE. AFTER INSERTING THE NAIL AND BLADE, THE SURGEON USED THE FLEXIBLE SCREWDRIVER AND TRIED TO LOWER THE LOCKING MECHANISM, BUT THE TIP OF THE SCREWDRIVER COULD NOT REACH THE LOCKING MECHANISM EASILY. WHILE CHECKING THE AREA AROUND THE CONNECTION BETWEEN THE NAIL AND THE INSERTION HANDLE WITH AN IMAGE INTENSIFIER, THE SURGEON TRIED VARIOUS THINGS FOR ABOUT 5 TO 10 MINUTES, SUCH AS TURNING THE AFFECTED SIDE INWARD, PUSHING THE SCREWDRIVER HARDER, AND CHANGING THE SURGEON. AFTER THAT, TURNING/LOWERING THE LOCKING MECHANISM SUCCEEDED, AND THE SURGERY WAS CONTINUED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 90 - SILE THIS IS REPORT 5 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18838928 ↗
• MalfunctionJan 16, 2024Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 THE PATIENT UNDERWENT ORIF SURGERY FOR FEMORAL INTERTROCHANTERIC FRACTURE WITH TFNA. DURING THE PROCEDURE, THE SURGEON USED TFNA EXTRA SHORT NAIL. WHEN HE INSERTED THE BLADE IN QUESTION, DISARTICULATION OF THE FRACTURE LINE OCCURRED. HE REMOVED THE BLADE AND THE TIP OF THE BLADE BROKE. THE FRAGMENTED PART WAS RETAINED IN THE PATIENT¿S BODY. THE SURGEON USED THE LONGER BLADE, INSTEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH MORE THAN 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TFNA FENESTRATED HELICAL BLADE 90MM STERILE. THIS IS REPORT 1 OF 1 FOR: (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 18518652 ↗
• 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 TFNA FENESTRATED HELICAL BLADE 90MM ¿ STERILE. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17985683 ↗
• MalfunctionMay 9, 2023Migration; Migration

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)2023, THE PATIENT UNDERWENT ORIF SURGERY FOR FRACTURE OF THE BASE OF THE THIGH BONE WITH TFNA 90 MM HELICAL BLADES. THE BLADE WAS INSERTED DEEPER THAN PLANNED, HOWEVER THE SURGEON DETERMINED IT TO BE ACCEPTABLE AND AUGMENTATION WAS PERFORMED. THE SURGEON THEN CHECKED THE LATERAL SIDE AND FOUND THAT THE TIP OF THE BLADE SEEMED TO BE SLIGHTLY PIERCED INTO THE BONE HEAD. SINCE THIS SITUATION WAS NOT ACCEPTABLE, THE 90 MM BLADE WAS ONCE REMOVED, AND AN 85 MM BLADE WAS REINSERTED. THE SURGEON CHECKED THE FRONT AND LATERAL IMAGE TO MAKE SURE THERE WERE NO PROBLEMS, AND THE OPERATION WAS COMPLETE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 15 MINUTES. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TFNA FENESTRATED HELICAL BLADE 90MM ¿ STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16896968 ↗
• 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 TFNA FENESTRATED HELICAL BLADE 90MM ¿ STERILE. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16372062 ↗
• MalfunctionOct 31, 2022Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT ON (B)(6) 2022, THE 90MM HELICAL BLADE WOULD NOT INSERT OVER THE GUIDE WIRE. ANOTHER SET WAS OPENED TO CHECK THE INSERTER AND CONNECTING SCREW. IT WAS DETERMINED THAT ANOTHER HELICAL BLADE NEEDED TO BE OPENED TO COMPLETE THE PROCEDURE. THERE WAS A 15-MINUTE DELAY IN SURGERY IN RELATION TO THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO CONSEQUENCE TO THE PATIENT. THIS REPORT INVOLVES ONE TFNA FENESTRATED HELICAL BLADE 90MM - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15699244 ↗
• InjuryOct 4, 2022Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO IMPLANT A TFNA WITH A HELICAL BLADE ON (B)(6) 2022. AFTERWARD, ON AN UNKNOWN DATE, THE NAIL COLLAPSED AND THE HELICAL BLADE MOVED A TON LATERALLY. REVISION SURGERY IS NEEDED TO REMOVE THE HEAD ELEMENT AND REPLACE IT WITH A SHORTER ONE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE TFNA FENESTRATED HELICAL BLADE 90MM - STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15536141 ↗
• InjuryOct 3, 2022Migration; Migration

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT ORIF FOR LEFT FEMORAL TROCHANTERIC FRACTURE. AFTER SURGERY, THE PATIENT WAS REHABILITATED IN ANOTHER HOSPITAL AND THE BONE UNION WAS CONFIRMED IN (B)(6) 2022. AT THE END OF (B)(6) 2022, THE PATIENT FELL AND HAD PAIN. ON (B)(6) 2022, THE PATIENT VISITED THE HOSPITAL AND IT WAS CONFIRMED THAT THE BLADE HAD PERFORATED THE BONE HEAD. IT WAS PLANNED TO REMOVE THE TFNA IN QUESTION AND PERFORM THA SURGERY ON (B)(6) 2022. THE SURGEON COMMENTED THAT THE BLADE PERFORATED THE BONE HEAD DUE TO THE PATIENT FALL, BECAUSE THE BONE UNION WAS CONFIRMED IN APRIL. IT WAS POSSIBLE THAT LSC (LATE SEGMENTAL COLLAPSE) OCCURRED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TFNA FENESTRATED HELICAL BLADE 90MM - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Tissue Injury

  MAUDE report 15530890 ↗
• InjurySep 14, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022 SURGEON REMOVED HELICAL BLADE DUE TO BACKING OUT AND REPLACED WITH TINA SCREW. DISTAL SCREWS ALSO BROKEN. THERE WAS NO SURGERY DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 90 - SILE. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15422070 ↗
• MalfunctionJun 9, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, THE HELICAL BLADE WOULD NOT SLIDE THRU THE 3.2 GUIDEWIRE. A NEW BLADE WAS PROVIDED AND USED WITHOUT INCIDENT. THIS REPORT INVOLVES ONE (1) TFNA FENESTRATED HELICAL BLADE 90MM ¿ STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14647124 ↗
• InjuryJun 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD A LONG TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA) NAIL IMPLANTED 2 WEEKS AGO. THE PATIENT FELL POSTOPERATIVELY AND IMPLANTS NEEDED TO BE REMOVED AND REVISED TO A HEMIARTHROPLASTY. THE PROCEDURE AND THE PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 90MM - STERILE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

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

  MAUDE report 14599846 ↗
• 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

  Patient problems: Bone Fracture(s)

  MAUDE report 14254528 ↗
• InjuryMar 4, 2022Migration; Migration

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A MEETING OF THE AOTC HELD ON (B)(6) 2021, SLIDES WERE PRESENTED WHICH REPRESENTED FOUR TFNA CASES WITH MEDIAL BLADE MIGRATION INTO THE PELVIC AREA. ALL FOUR CASES WERE REVISED TO A PROSTHESIS. THIS CAPTURES THE CASE WITH PATIENT: FEMALE, (B)(6) AT TIME OF EVENT. PATIENT BEGAN TO COMPLAIN OF PAIN ON (B)(6) 2022. THIS REPORT IS FOR A TFNA FENESTRATED HELICAL BLADE 90MM - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Pain

  MAUDE report 13666786 ↗
• InjuryJul 21, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT SURGERY WITH THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) SYSTEM. THE IMPLANTS BROKE IN THE PATIENTS A FEW WEEKS LATER ON AN UNKNOWN DATE. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT REVISION SURGERY. THE TFNA IMPLANTS WERE REMOVED AND A LARGER NAIL WAS IMPLANTED. THE PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICE REPORTED: UNK - SCREW: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN); HELICAL BLADE (PART# 04.038.390S; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 90MM - STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

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

  MAUDE report 12204827 ↗
• InjuryJul 16, 2021Break; Break

  IT WAS REPORTED ON (B)(6) 2021 PATIENT UNDERWENT REMOVAL OF A BROKEN PROXIMAL FEMORAL NAILING SYSTEM TFNA (TFNA) NAIL. IT WAS ORIGINALLY IMPLANTED ON (B)(6) 2021. THERE WAS PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN TFNA END CAP (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN NAIL DISTAL LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1)TFNA FENESTRATED HELICAL BLADE 90 - SILE. THIS REPORT IS 2 OF 2 FOR (B)(4).

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

  MAUDE report 12185164 ↗
• InjuryNov 24, 2020Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2020, PATIENT UNDERWENT REMOVAL OF FEMORAL NAIL AND WAS CONVERTED TO TOTAL HIP DUE TO CUT OUT. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 90MM - STERILE. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 10896960 ↗
• InjuryAug 21, 2020Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO THE PROXIMAL FEMORAL NAILING SYSTEM (TFNA) NAIL AND THE HELICAL BLADE BECAME DISCONNECTED WHEN THE HELICAL BLADE CUT THROUGH THE FEMORAL HEAD. THE INTERNAL LOCKING MECHANISM WHICH HOLDS THE HELICAL BLADE WAS EITHER NOT CORRECTLY DEPLOYED DURING SURGERY OR THERE WAS A FAILURE OF THIS COMPONENT AS THE TFNA NAIL AND HELICAL BLADE WERE NO LONGER IN CONTACT. THE PATIENT STATUS AND THE PROCEDURE OUTCOME ARE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN LOCKING SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) TFNA FENESTRATED HELICAL BLADE 90MM - STERILE. THIS IS REPORT 1 OF 1 (B)(4).

  Patient problems: No Code Available

  MAUDE report 10439823 ↗
• InjuryAug 19, 2020Migration; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE WHEN THE PATIENT FELL APPROXIMATELY FIVE (5) WEEKS POST-IMPLANT, THE TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) HELICAL BLADE CUT OUT AND EXPERIENCED PAIN. THE PATIENT WAS ORIGINALLY IMPLANTED WITH A TFNA SYSTEM ON AN UNKNOWN DATE. THUS, THE SURGEON REMOVED THE TFNA IMPLANTS AND REPLACING THEM WITH A BIPOLAR HIP. CONCOMITANT DEVICES REPORTED: UNKNOWN LOCKING SCREW ( PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1); UNKNOWN END CAP ( PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1); TFNA NAIL (PART# 04.037.260S, LOT# 25P3815, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; Pain

  MAUDE report 10426493 ↗
• InjuryJun 9, 2020Migration; Migration

  UPDATED: CONCOMITANT DEVICE REPORTED: UNKNOWN LOCKING SCREWS (PART# UNKNOWN, LOT# UNKNOWN , QUANTITY# UNKNOWN).

  Patient problems: No Code Available

  MAUDE report 10133352 ↗
• 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 MEDICAL PRODUCTS: 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) TFNA FENESTRATED HELICAL BLADE 90MM

  Patient problems: No Patient Involvement

  MAUDE report 8525084 ↗
• InjuryFeb 6, 2019Device-Device Incompatibility; Migration; Device-Device Incompatibility; Migration

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING INSERTION OF TROCHANTERIC FEMORAL NAILING ADVANCED (TFNA) NAIL, THE SURGEON TRIED TO COMPRESS THE HELICAL BLADE BUT THERE WAS A BACK OUT. THE SURGEON DECIDED NOT TO COMPRESS THE BLADE, BUT RATHER LOCKED THE BLADE INSTEAD. THIS ALLOWED THE BLADE TO SLIDE AS NORMAL (GUIDED COLLAPSE). IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 90MM - STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8310132 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under 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