TFN-ADVANCE 04.037.159SRecalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10886982096678), received between Jan 15, 2018 and Sep 23, 2026 — classified as 27 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Difficult to Advance

  It was reported that the set screw on the proximal end had been pre-deployed. There was no patient harm and no surgical delay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869866 ↗
• InjuryOct 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT WAS DIAGNOSED DUE TO INFECTION AND UNDERWENT HARDWARE REMOVAL. IT WAS UNKNOWN IF THERE WAS ANY PATIENT CONSEQUENCES/OUTCOME. THIS REPORT INVOLVES ONE 11/130 DEG TI CANN TFNA 380/LEFT - SILE.

  Patient problems: Unspecified Infection

  MAUDE report 20359490 ↗
• InjuryDec 1, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, THE SURGEON IMPLANTED A LONG TROCHANTERIC FIXATION NAIL- ADVANCED (TFNA) FOR A SUBTROCHANTERIC FEMUR FRACTURE. THERE WAS A NON-UNION AND THE NAIL EVENTUALLY BROKE. THE BROKEN NAIL, LAG SCREW, AND TWO DISTAL 5.0MM LOCKING SCREWS WERE REMOVED ON (B)(6) 2023. THE REVISION ENTAILED IMPLANTATION OF A GAMMA 3 NAIL, LAG SCREW, AND TWO DISTAL SCREWS. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT IS FINE AND STABLE. THIS REPORT IS FOR ONE (1) 11MM/130 DEG TI CANN TFNA 380MM/LEFT - STERILE THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18252387 ↗
• InjuryJul 28, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023 THE SURGEON IMPLANTED A TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA) TO TREAT PATIENT'S LEFT INTERTROCHANTERIC FRACTURE. DURING PROCEDURE THE SURGEON HAD A DIFFICULT TIME GETTING THE LATERAL OPENING DRILL AND THE 6/9MM STEP DRILL TO PASS THROUGH THE NAIL. HE PROCEEDED TO IMPLANT THE TFNA LAG SCREW AND ALSO IMPLANT THE DISTAL INTERLOCKING SCREWS. SURGEON DID NOT NOTICE ON INTEROPERATIVE X RAYS THAT THE LAG SCREW WAS ANTERIOR TO THE NAIL. UPON REVIEW OF THE POST OPERATIVE X RAYS SURGEON REALIZED THAT THE LAG SCREW WAS IMPLANTED ANTERIOR TO THE NAIL AND THAT IT DID NOT PASS THROUGH THE NAIL. IT WAS DETERMINED THAT THE NAIL WAS NOT ASSEMBLED TO THE INSERTION HANDLE CORRECTLY WHICH ALLOWED THE ANGLE GUIDE TO ROTATE AND MISS THE NAIL ANTERIOR. REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 WHERE THE NAIL AND LAG SCREW WERE REMOVED WITHOUT ISSUE AND A NEW NAIL AND LAG SCREW WERE IMPLANTED IN THE CORRECT ORIENTATION. THE STATUS OF THE PATIENT AT THIS TIME IS THAT THEY ARE RECOVERING AND THE REVISION NAIL SURGERY WAS SUCCESSFUL. THERE WAS NO DELAY DURING THE REVISION PROCEDURE. THIS REPORT IS FOR ONE (1) 11MM/130 DEG TI CANN TFNA 380MM/LEFT - STERILE. THIS I

  Patient problems: Insufficient Information

  MAUDE report 17417117 ↗
• MalfunctionJul 22, 2023Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT ON (B)(6) 2023 WHILE THE SURGEON WENT TO SET THE SET SCREW THAT WAS PRE LOADED INTO THE NAIL, IT WAS CROSS THREADED. ONCE THIS WAS REALIZED THE SURGEON TURNED IT COUNTER CLOCKWISE AND THEN CLOCKWISE TO ATTEMPT TO FREE IT UP. THE PROCESS WAS REPEATED FOR ABOUT 10-12 MINUTES. THE SURGEON THEN GOT IT NEARLY ALL THE WAY DOWN. HOWEVER THE SCREW IN THE FEMORAL HEAD WAS STILL ABLE TO BE TURNED WHICH REVEALED THE SET THAT WAS NOT DOWN PROPERLY. THIS REPORT IS FOR ONE (1) 11MM/130 DEG TI CANN TFNA 380MM/LEFT - STERILE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17375372 ↗
• InjurySep 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 THAT THE PATIENT ORIGINALLY UNDERWENT SURGERY FOR A SUBTROCHANTERIC FEMUR FRACTURE IN MARCH 2022, TREATED WITH A TFNA NAIL, HELICAL BLADE, AND LOCKING SCREW. THE FRACTURE WENT ON TO NON-UNION AND THE NAIL FRACTURED AT THE PROXIMAL HELICAL BLADE APERTURE. ON (B)(6) 2022 THE NAIL, HELICAL BLADE, AND SCREW WERE REMOVED WITHOUT INCIDENT. A NEW TFNA NAIL, HELICAL BLADE, AND LOCKING SCREW WERE INSERTED. THIS REPORT INVOLVES ONE 11MM/130 DEG TI CANN TFNA 380MM/LEFT - STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15410493 ↗
• InjuryOct 26, 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 REMOVAL OF TFNA DUE TO NONUNION IN THE FEMORAL NECK. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR ONE (1) 11/130 DEG TI CANN TFNA 380/LEFT - SILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12698637 ↗
• InjuryAug 31, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT REMOVAL SURGERY DUE TO A BROKEN TROCHANTERIC FIXATION NAIL ADVANCED (TFNA). PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNK - SCREW: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). HELICAL BLADES, PERFORATED, STERILE (PART:04.038.400S; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) 11MM/130 DEG TI CANN TFNA 380MM/LEFT - STERILE. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

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

  MAUDE report 12393683 ↗
• InjuryAug 23, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A HARDWARE REMOVAL OF PROXIMAL FEMORAL NAILING SYSTEM (TFNA). THE ORIGINAL TFN NAIL WAS 3 BROKEN PIECES. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1); UNK - SCREWS: NAIL DISTAL LOCKING (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS COMPLAINT INVOLVES ONE(1) DEVICE. THIS REPORT IS FOR (1) 11MM/130 DEG TI CANN TFNA 380MM/LEFT - STERILE. THIS REPORT IS 1 OF 1 FOR (B)(4).

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

  MAUDE report 12353761 ↗
• InjuryJun 25, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A HARDWARE REMOVAL PROCEDURE OF A BROKEN TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL. THE PATIENT RECEIVED A PROXIMAL FEMORAL REPLACEMENT ARTHROPLASTY. THIS NAIL WAS REMOVED FROM A PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - NAIL HEAD ELEM: TFNA HELICAL BLADE (PART# UNKNOWN; LOY# UNKNOWN; QUANTITY: 1), UNK -SCREWS: NAIL DISTAL LOCKING (PART# UNKNOWN; LOY# UNKNOWN; QUANTITY: 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 11/130 DEG TI CANN TFNA 380/LEFT - SILE THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12068417 ↗
• InjuryDec 8, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL BROKE POSTOPERATIVELY. THE BROKEN NAIL WAS REMOVED ON (B)(6) 2020. NO FURTHER INFORMATION IS PROVIDED. CONCOMITANT DEVICE REPORTED: UNKNOWN TFNA HELICAL BLADE (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1); UNKNOWN LOCKING SCREW (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR ONE (1) 11MM/130 DEG TI CANN TFNA 380MM/LEFT - STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 10971828 ↗
• InjuryNov 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN, PATIENT UNDERWENT REMOVAL OF TITANIUM CANNULATED PROXIMAL FEMORAL NAILING SYSTEM (TFNA) AND PLACING A TOTAL HIP FOR AN UNKNOWN REASON. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY. PATIENT STATUS WAS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN 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 380MM/LEFT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Injury; No Code Available

  MAUDE report 10779803 ↗
• InjuryJun 22, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON STATICALLY LOCKED THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) FENESTRATED HELICAL BLADE 90MM STERILE. POST-OPERATIVE FOLLOW-UP FILMS SHOW THAT THE HELICAL BLADE HAS COLLAPSED AND HAS CUT OUT OF THE FEMORAL HEAD. THE NAILS LOCKING MECHANISM DID NOT PREVENT THE HELICAL BLADE FROM COLLAPSING DESPITE THE SURGEON STATICALLY LOCKING THE HELICAL BLADE. THERE IS NO SURGICAL DELAY AND NO ADVERSE EVENT HAPPENED POST-SURGERY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT STATUS AFTER THE PROCEDURE, PATIENT HAS A FAILED DEVICE SINCE THE HELICAL BLADE CUT OUT OF THE HEAD AND COLLAPSED THROUGH THE NAIL. THIS REPORT IS FOR 1 11MM/130 DEG TI CANN TFNA 380MM/LEFT - STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10178852 ↗
• InjuryJun 11, 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 UNDERWENT REMOVAL OF THE TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) SYSTEM DUE TO MALREDUCTION/ NONUNION. THE PATIENT WAS ORIGINALLY IMPLANTED WITH THE TFNA SYSTEM ON AN UNKNOWN DATE. THIS IS REPORT 2 OF 4 FOR (B)(4).

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

  MAUDE report 10143197 ↗
• InjuryMay 18, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING REMOVAL OF PROXIMAL FEMORAL NAILING SYSTEM (TFNA) LONG NAIL AND THE TITANIUM HELICAL BLADE, THE SURGEON REMOVED ONE (1) DISTAL INTERLOCK 5.0MM LOCKING SCREW AND PUT EXTRACTION INSTRUMENT ON THE HELICAL BLADE THEY THEN CONNECTED THE EXTRACTION BOLT TO THE PROXIMAL INSTRUMENTED END OF THE TFNA REMOVED THE HELICAL BLADE. THEY EXTRACTED THE BROKEN PROXIMAL END THEN PROCEEDED TO ATTEMPT TO REMOVE THE DISTAL BROKEN PORTION OF THE TFNA NAIL WITH AN EXTRACTION HOOK WITH NO SUCCESS FOR 2-3 HOURS. THEN MOVED TO THE DISTAL FEMUR TO MAKE AN OPENING HOLE DISTAL TO THE NAIL SO THEY CAN DRIVE OUT THE NAIL FROM THE DISTAL (RETROGRADE) END. THEY PROCEEDED IN DRIVING THE NAIL UNTIL THE INSTRUMENTED PROXIMAL PORTION OF THE NAIL WAS EXPOSED OUTSIDE OF THE SOFT TISSUE. THEY PUT THE EXTRACTION HOOK BACK INTO THE NAIL AND PULLED IT COMPLETELY OUT. IT IS UNKNOWN THERE WAS A SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS GOOD. THIS (B)(4) CAPTURES THE INTRAOPERATIVE EVENT THAT DURING REMOVAL THERE WAS AN ADDITIONAL INTERVENTION THAT WAS REQUIRED TO REMOVE NAIL WHILE, THIS (B)(4) CAPTURES THE OPS-OPERATIVE EVENT THAT THE BROKEN P

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10067264 ↗
• InjuryMay 18, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE BROKEN PROXIMAL FEMORAL NAILING SYSTEM (TFNA) LONG NAIL AND THE TITANIUM HELICAL BLADE WERE REMOVED DUE TO DELAYED HEALING AND NON-UNION. THE PATIENT MENTIONED THAT SHE WAS SIMPLY DOING HOUSEWORK AND FELT PAIN IN THE LEFT HIP. X RAYS SHOWED THAT THE TFNA BROKE, DISTAL TO THE HELICAL BLADE. THE SURGEON REMOVED THE ONE (1) DISTAL INTERLOCK 5.0MM LOCKING SCREW AND PUT EXTRACTION INSTRUMENT ON THE HELICAL BLADE. THEY THEN CONNECTED THE EXTRACTION BOLT TO THE PROXIMAL INSTRUMENTED END OF THE TFNA AND REMOVED THE HELICAL BLADE. THEY EXTRACTED THE BROKEN PROXIMAL END THEN PROCEEDED TO ATTEMPT TO REMOVE THE DISTAL BROKEN PORTION OF THE TFNA NAIL WITH AN EXTRACTION HOOK WITH NO SUCCESS FOR TWO (2)- THREE (3)HOURS, THEN MOVED TO THE DISTAL FEMUR TO MAKE AN OPENING HOLE DISTAL TO THE NAIL SO THEY CAN DRIVE OUT THE NAIL FROM THE DISTAL (RETROGRADE) END. THEY PROCEEDED IN DRIVING THE NAIL UNTIL THE INSTRUMENTED PROXIMAL PORTION OF THE NAIL WAS EXPOSED OUTSIDE OF THE SOFT TISSUE. THEY PUT THE EXTRACTION HOOK BACK INTO THE NAIL AND PULLED IT COMPLETELY OUT. THE BROKEN TFNA WAS REPLACED WITH A TITANIUM TROCHANTERIC FIXATION NAIL (TFN) AND A REMOVED HELICAL

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

  MAUDE report 10065094 ↗
• MalfunctionApr 27, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING SUBTROCHANTERIC FEMUR FRACTURE OF THE LEFT HIP PROCEDURE, THE TROCHANTERIC FIXATION NAIL ADVANCED SYSTEM (TFNA) WITH LAG SCREW AND CANNULATED STEPPED DRILL BIT WERE USED TO FIX THE DEVICE. USING THE TFNA AND THE DRILL BIT THE SURGEON WAS ABLE TO GET A GOOD REDUCTION OF THE FEMUR FRACTURE AND WAS ABLE TO PUT TFNA NAIL IN PLACED. WHEN THE SURGEON WAS USING A STEPPED DRILL BIT, IT WAS OBSERVED THAT THE DRILLING WAS VERY HARD AND NOTICED A LOT OF SQUEAKING THAT WAS HAPPENING AND LOT OF RESISTANCE, SO IT WAS IMMEDIATELY CONVINCED THAT THE STEPPED DRILL BIT IS DEFLECTING. IT WAS ALSO DECIDED THAT THEY DID COME DOWN THE BLADE GUIDE WAS COMPRESSED AGAINST THE FEMUR BEING A BUTCHER COMPRESSION THAT IS OVERTIGHTENED. THE TFNA HAS A RECENT HISTORY OF BREAKAGE DUE TO DRILL BIT STRIKE AGAINST THE NAIL. OUT OF CONCERN, DAMAGING, RUINING AND AFFECTING THE NAIL THE SURGEON SELECTED TO EXCHANGE THE NAIL. AND AS A RESULT, THE NAIL WENT BACK IMMEDIATELY. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT CONSEQUENCE IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - NAIL HEAD ELEM: TFNA LAG SCREW (PART# UNKNOWN; LOT# UNKN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10002649 ↗
• InjuryFeb 26, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REMOVAL SURGERY DUE TO A BROKEN 11MM/130 DEGREE TITANIUM CANNULATED PROXIMAL FEMORAL NAILING SYSTEM (TFNA) NAIL. THE NAIL BROKE JUST ABOVE THE LAG SCREW. IT IS BEING REPLACED WITH THE NEPHEW INTERTAN BECAUSE OF A NONUNION BREAKAGE. PROCEDURE OUTCOME AND PATIENT STATUS WERE UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: TFNA LAG SCREW (PART # 04.038.205, LOT # 10L7781, QUANTITY 1). UNKNOWN LOCKING SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN TFNA END CAP (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS REPORT 1 FOR 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9756990 ↗
• MalfunctionJan 22, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019 DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) HIP WITH CEPHALOMEDULLARY NAIL PROCEDURE, THE SET SCREW OF A PROXIMAL FEMORAL NAILING SYSTEM (TFNA) LONG NAIL WOULD NOT LOCK ALL THE WAY DOWN. THE NAIL WAS TAKEN OUT OF THE SET SCREW AND APPEARED TO BE NOT WORKING PROPERLY, BY NOT LOCKING ALL THE WAY DOWN AS SEEN ON THE X-RAY. ANOTHER TFNA LONG NAIL WAS USED. THE PRODUCT WAS IMPLANTED AS PLANNED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 10-15 MINUTE SURGICAL DELAY. THE PATIENT'S STATUS IS UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN TFNA 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 REPORT IS FOR ONE 11MM/130 DEG TI CANN TFNA 380MM/LEFT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9617707 ↗
• InjuryAug 2, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION PROCEDURE BECAUSE OF A LONG TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL WHICH WAS BROKEN AT THE BUMP CUT DUE TO A NON-UNION AND POSSIBLE SIGNS OF INFECTION INSIDE THE NAIL. INITIALLY, THE PATIENT WAS IMPLANTED WITH THE REPORTED TFNA LAST (B)(6) 2019. THE ISSUE WAS DISCOVERED WHEN THE PATIENT EXPERIENCED PAIN ON HIS HIP. DURING THE REVISION PROCEDURE, THE REPORTED NAIL WAS REMOVED AND WAS SENT FOR CULTURE TESTING AS THERE WAS AN UNUSUAL WHITE-COLORED TISSUE/SUBSTANCE IN THE CANAL OF THE NAIL, THEN A TOTAL HIP ARTHROPLASTY (THA) WAS IMPLANTED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS AND SURGICAL OUTCOME WERE UNKNOWN. THIS COMPLAINT INVOLVES UNKNOWN NUMBER OF DEVICES. THIS REPORT IS 1 OF 3 FOR (B)(4).

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 8857842 ↗
• InjuryJul 3, 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 ONE (1) TITANIUM CANNULATED TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) NAIL, ONE (1) TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) SCREW, AND TWO (2) UNKNOWN 5MM LOCKING SCREWS DUE TO INFECTION AND PLACEMENT OF ANTIBIOTIC SPACER. THE DATE OF ORIGINAL IMPLANT WAS ON (B)(6) 2018. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS GOOD. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8758156 ↗
• InjuryApr 16, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT WAS INITIALLY IMPLANTED WITH TFN-ADVANCED PROXIMAL FEMORAL NAILING SYSTEM (TFNA) ON (B)(6) 2019. POSTOPERATIVELY PATIENT COMPLAINED OF PAIN AND CLICKING IN HER HIP. X-RAY TAKEN ON AN UNKNOWN POSTOPERATIVE DATE REVEALED THAT THE TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL IMPLANT WAS BROKEN. PATIENT UNDERWENT A HARDWARE REMOVAL ON (B)(6) 2019 AND WAS IMPLANTED WITH LARGER TROCHANTERIC NAIL. PER SURGEON DEVICE DID NOT COME OUT EASILY. SURGEON HAD TO REMOVE THE BLADE AND THEN THE ENTIRE NAIL CAME OUT IN ONE PIECE (FRACTURED COMPLETELY ON ONE HALF AND NEARLY FRACTURED ALL THE WAY THROUGH BUT HELD TOGETHER JUST ENOUGH TO COME OUT IN ONE PIECE). IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: TFNA HELICAL BLADE (PART# 04.038.300, LOT # H540343, QUANTITY #1).UNKNOWN - SCREWS: (PART # UNKNOWN , LOT # UNKNOWN, QUANTITY #2). 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 8519299 ↗
• InjuryDec 12, 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 (TFNA) PROXIMAL FEMORAL NAILING SYSTEM DUE TO PAINFUL NON-UNION. DURING PROCEDURE, UPON EXTRACTING THE TFNA HELICAL BLADE, THE EXTRACTION INSTRUMENT FOR TFNA HELICAL BLADE AND SCREW WOULD NOT WORK. THE SURGEON HAD TO USE THE HELICAL BLADE/SCREW COUPLING SCREW TO REMOVE THE BLADE. THERE WAS ALSO A DISTAL LOCKING SCREW THAT BROKE AND BOTH PIECES WERE REMOVED. ADDITIONALLY, SURGEON HAD ISSUES ENGAGING THE EXTRACTION INSTRUMENT FOR NAILS, CANNULATED TO THE TOP OF THE NAIL AND SAID IT¿S NOT TAPPED AND VERY TOUGH TO ENGAGED IN TO THE NAIL. THE EXTRACTION INSTRUMENT FOR NAILS FINALLY ENGAGED, AND THE NAIL WAS REMOVED. THE SURGEON THEN PROCEEDED TO INSERT A SMITH AND NEPHEW NAIL AND THE SURGERY WAS COMPLETED WITH NO ISSUES. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. THIS (B)(4) CAPTURES THE POST-OPERATIVE BROKEN SCREW. (B)(4) CAPTURES THE INTRA-OPERATIVE EVENT OCCURRED DURING REMOVAL. THIS REPORT IS FOR ONE (1) TFNA NAIL. THIS IS REPORT 2 OF 3 FOR (B)(4).

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

  MAUDE report 8157120 ↗
• InjurySep 4, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE 130 DEGREE TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL ADVANCE (TFNA) WAS FOUND BROKEN. ON (B)(6) 2018, THE INITIAL UNKNOWN SURGERY WAS PERFORMED, WHEREIN THE SURGEON IMPLANTED A 130 DEGREE TITANIUM CANNULATED TFNA WITHOUT ANY REPORTED ISSUES. DURING THE REVISION SURGERY ON (B)(6) 2018, THE SURGEON EXPLANTED THE BROKEN 130 DEGREE TITANIUM CANNULATED TFNA AND REPLACED IT WITH AN UNKNOWN PLATE. IT IS UNKNOWN IF ALL FRAGMENTS WERE REMOVED. SURGICAL DELAY AND PATIENT CONSEQUENCE ARE UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN HELICAL BLADE (PART #: UNKNOWN, LOT#: UNKNOWN, QUANTITY: UNKNOWN). UNKNOWN SCREW (PART #: UNKNOWN, LOT#: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) 11MM/130 DEG TI CANN TFN 380MM/LEFT - STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

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

  MAUDE report 7842739 ↗
• InjuryJun 26, 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 REMOVAL OF TITANIUM CANNULATED FIXATION NAIL-ADVANCED (TFNA), TFNA FENESTRATED SCREW AND TWO (2) TITANIUM LOCKING SCREWS DUE TO PATIENT BROKE THE FEMUR BONE AGAIN. DEVICES WERE ORIGINALLY IMPLANTED ON AN UNKNOWN DATE. THERE WERE NO ALLEGATIONS AGAINST THE DEVICES YET THE SURGEON DECIDED TO CONVERT THE IMPLANTS TO A TOTAL HIP REPLACEMENT. ALL IMPLANTS WERE REMOVED EASILY AND INTACT WITH NO SURGICAL DELAY. PATIENT OUTCOME WAS STABLE. THIS REPORT IS FOR ONE (1) 11MM/130 DEGREE TI CANNULATED TFNA 380MM/LEFT - STERILE. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

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

  MAUDE report 7639353 ↗

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-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-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