TFN-ADVANCE 04.038.395SRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10886982099273), received between May 11, 2018 and Mar 5, 2026 — classified as 19 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Migration” (11 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2026Migration

  IT WAS REPORTED THAT TFNA HELICAL BLADE PERF L95 TAN AND UNK - GUIDES/SLEEVES/AIMING: SLEEVE WERE INVOLVED IN AN INTRA-OPERATIVE EVENT DURING A TRAUMA PROCEDURE. THE REPORTED FAILURE INVOLVED THE BLADE BEING IMPACTED THROUGH THE FEMORAL HEAD AND THE PRONG OF THE SLEEVE BEING DRIVEN INTO BONE. THE IMPLANTS WERE IMPLANTED. THE EVENT RESULTED IN A 30-MINUTE SURGICAL DELAY AND REQUIRED ADDITIONAL MEDICAL INTERVENTION, INCLUDING SEVERAL C-ARM IMAGES. NO INVASIVE MEDICAL OR SURGICAL INTERVENTION WAS PROVIDED FOR THE REPORTED BONE INJURY.

  Patient problems: Bone Notching

  MAUDE report 24519758 ↗
• MalfunctionFeb 15, 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 MALE PATIENT UNDERWENT UNKNOWN SURGERY WITH TFNA IMPLANT FOR TROCHANTERIC FRACTURE. A BLADE WAS AIMED TO BE INSERTED INTO BONEHEAD BEYOND A GUIDEWIRE, BUT THE GUIDEWIRE INTERFERED WITH INSIDE OF THE BLADE AND THE BLADE WAS UNABLE TO PASS THROUGH. THE GUIDEWIRE ITSELF SEEMED NOT TO HAVE FLAW, AND CONNECTING THE BLADE WITH AN INSERTER WAS TRIED AND CHECKED, BUT THERE WAS NO DISCOVERY FOR THE CAUSE. A DECISION WAS MADE FOR THE BLADE PLANNED TO BE INSERTED WITHOUT GUIDEWIRE. THE BLADE WAS INSERTED ECCENTRICALLY, AND IT WAS TAKEN BACK, INSERTION MOVE WAS RETRIED AS THAT CONDITION, BUT THE BLADE WAS UNABLE TO PASS THROUGH THE GUIDEWIRE. ANOTHER BLADE WAS NEWLY TRIED TO BE USED FOR INSERTION AND IT PASSED THROUGH EXACTLY THE GUIDEWIRE. ALTHOUGH TOTAL SURGICAL TIME WAS SCHEDULED TO BE 20 MINUTES, THE SURGERY WAS COMPLETED SUCCESSFULLY WITH AN ADDITIONAL 45 MINUTES. AFTER THE SURGERY, THE BLADE IN QUESTION AND THE INSERTER WAS CONNECTED TO CHECK IF IT CAN PASS THROUGH THE GUIDEWIRE, AND IT COULD NOT BE INSERTED AS THE SAME TIME AS UNSUCCESSFUL SITUATION, AND NEXT, EACH OF DEVICE, THE BLA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18711980 ↗
• InjuryMay 12, 2023Migration; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, TROCHANTERIC FIXATION NAIL (TFNA) WAS REMOVED AS PATIENT HAD BLADE CUT OUT. THE PATIENT WAS CONVERTED TO A TOTAL. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 95MM - STERILE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16924408 ↗
• MalfunctionApr 11, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DRILLSL YELL AND TROCAR YELL IS SITTING VERY TIGHT TOGETHER, SO THAT THE TROCAR YELL DON¿T FIT CORRECT INTO THE DRILLSL YELL AND BECAUSE OF THAT THE SURGEON GET A WRONG MEASURING OF LENGTH OF THE GUIDEWIRE. THIS IS REPORT 2 OF 6 FOR COMPLAINT (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16718524 ↗
• MalfunctionMar 30, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2023, THE INSIDE OF HELICAL BLADE IS NOT THREADED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 5 MINUTES. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 95 - SILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16643420 ↗
• MalfunctionFeb 14, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, BLADE WILL NOT PASS OVER A 3.2MM GUIDE WIRE 400MM WHEN CONNECTED TO HELICAL BLADE. CANNULA IS DEFORMED. NO OPERATION INVOLVED. NO PATIENT INVOLVED. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 95 - SILE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16375819 ↗
• InjuryNov 21, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022 THERE WAS A REMOVAL OF A TFNA NAIL, HELICAL BLADE, AND NAIL SCREW THAT HAD CUT OUT OF THE NAIL. THE PATIENT CAME INTO THE ER DUE TO CUT OUT OF TFNA NAIL/HELICAL BLADE. THE TFNA FENESTRATED HELICAL BLADE EXITED MEDIALLY THROUGH THE TFNA SHORT NAIL AND LODGED IN THE PATIENT¿S PELVIS. AFTER REMOVAL OF THE TFNA COMPONENTS, THE PATIENT¿S FRACTURE WAS REPAIRED AGAIN USING NON-SYNTHES IMPLANTS. THE TFNA NAIL WAS EXAMINED AND THERE WAS EVIDENCE THAT THE IMPLANTING SURGEON THAT HAD FIRST FIXED THE FRACTURE DID NOT ENGAGE THE TFNA NAIL SET SCREW. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE TFNA FENESTRATED HELICAL BLADE 95MM - STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15837672 ↗
• InjurySep 6, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022, SURGEON PERFORMED A TFNA REVISION ON (B)(6),(TFNA SHORT TO TFNA LONG NAIL) BECAUSE THE LAG SCREW HAD BACKED COMPLETELY OUT. THIS WAS DUE TO THE SET SCREW NOT BEING ABLE TO ENGAGE THE LAG SCREW PROPERLY BECAUSE IT WAS LEFT AT 90 DEGREES OFF ANGLE. WE REMOVED AND REPLACED THAT NAIL WITH A LONG NAIL, HELICAL BLADE, TWO DISTAL LOCKING SCREWS AND ADDED TRAUMACEM. THE REDUCTION OF THE HIP WAS NOT GREAT AND THE CONSTRUCT WAS LIKELY TO FAIL, WHICH ULTIMATELY IT DID. ON (B)(6), SALES REP WAS CALLED IN FOR ASSISTANCE WITH A TFNA REMOVAL AT THE HOSPITAL WITH ANOTHER SURGEON. HE SHOWED X-RAYS AND TOLD SALES REP THAT THIS IS THE SAME PATIENT FROM THE FIRST SURGEON'S TWO PREVIOUS TFNA CASES. BECAUSE OF THE IMPERFECT REDUCTION THE NECK COLLAPSED CAUSING THE HELICAL BLADE TO CUT OUT THROUGH THE FEMORAL HEAD. SWITCHED TO HEMI-ARTHROPLASTY. IS UNKNOWN IF THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION,NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN,DEGENERATIVE DISEASES, BLEEDING OR OOZING? YES. DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? YES. HARDWARE/EXPLANT REMOV

  Patient problems: Failure of Implant

  MAUDE report 15363086 ↗
• InjuryAug 15, 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 REMOVAL OF TFNA WAS PERFORMED, IN PREPARATION FOR THA REMOVAL. THIS REPORT INVOLVES ONE (1) TFNA FENESTRATED HELICAL BLADE 95MM - STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

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

  MAUDE report 15223987 ↗
• 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 TFNA FENESTRATED HELICAL BLADE 95MM - STERILE. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: Necrosis

  MAUDE report 14828399 ↗
• InjuryFeb 4, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A REMOVAL SURGERY OF TFNA DUE TO CUT OUT CONVERTED TO TOTAL HIP. THE PROCEDURE SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME IS UNKNOWN. THIS REPORT INVOLVES ONE (1) TFNA FENESTRATED HELICAL BLADE 95MM - STERILE. THIS IS REPORT 3 OF 4 FOR (B)(4).

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

  MAUDE report 13452080 ↗
• InjuryJul 12, 2021Migration; Migration

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THE TROCHANTERIC FIXATION NAIL ANTI-ROTATION (TFNA) HELICAL BLADE CUT THROUGH THE FEMORAL HEAD OF THE PATIENT THREE (3) MONTHS POST-OPERATIVE. THIS WAS DISCOVERED AFTER THE PATIENT REPORTED HIP PAIN. THE PATIENT WAS REVISED TO A SHORTER TFNA SCREW. THIS REPORT IS FOR A TFNA HELICAL BLADE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 12149758 ↗
• InjuryMay 25, 2021Migration; Migration

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT REMOVAL OF HELICAL BLADES, PERFORATED. THE PATIENT HAD A HIP NAIL PUT IN SOME TIME AGO AND IN THIS PROCEDURE JUST HAD THE HELICAL BLADE REMOVED. HELICAL BLADE WAS PROTRUDING LATERALLY AS THE FRACTURE HEALED AND THE SURGEON CAME BACK TO REMOVE IT. CONCOMITANT DEVICE REPORTED: UNK - SCREW: (PART # UNKNOWN; LOT # UNKNOWN; QUANTITY: UNKNOWN), UNK - NAILS: TFNA (PART # UNKNOWN; LOT # UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 95MM - STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

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

  MAUDE report 11878309 ↗
• InjuryMay 14, 2021Break; Break

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT REVISION SURGERY FOR A BROKEN TITANIUM CANNULATED PROXIMAL FEMORAL NAILING SYSTEM (TFNA) AT PROXIMAL PORTION. BROKEN NAIL WAS REVISED TO A TOTAL HIP ARTHROPLASTY. CONCOMITANT DEVICES REPORTED: TFNA FENESTRATED HELICAL BLADE (PART# 04.038.395S, LOT# UNKNOWN, QUANTITY 1), UNKNOWN LOCKING SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN), UNKNOWN TFNA END CAP (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 95MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

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

  MAUDE report 11826518 ↗
• InjuryJun 30, 2020Migration; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A TOTAL HIP FOLLOWING CUTOUT OF THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) FENESTRATED HELICAL BLADE INTO THE JOINT. ORIGINALLY, THE PATIENT HAD AN OPEN REDUCTION INTERNAL FIXATION (ORIF) ON LEFT HIP ON (B)(6) 2020. THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) LONG NAIL, DISTAL LOCKING SCREWS AND HELICAL BLADE WERE REMOVED EASILY. NONE OF THE HARDWARE WAS BROKEN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL ADVANCED (PART NUMBER 04.037.259S, LOT UNKNOWN, QUANTITY 1), 5.0 DISTAL LOCKING SCREWS (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). THIS REPORT INVOLVES ONE (1) TFNA FENESTRATED HELICAL BLADE 95MM ¿ STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10211719 ↗
• InjurySep 13, 2019Migration; Migration

  THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 80MM - STERILE.

  Patient problems: No Code Available

  MAUDE report 9037093 ↗
• InjurySep 10, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, ON A FOLLOW-UP APPOINTMENT THE X-RAY SHOWS THE TIP OF THE TFNA HELICAL BLADE BROKEN OFF. ORIGINALLY THE PATIENT WAS IMPLANTED WITH TFNA (TROCHANTERIC FEMORAL NAIL-ADVANCED) DEVICES, THE NAIL, HELICAL BLADE, END CAP, AND A 5.0 MM LOCKING SCREW ON (B)(6) 2019. THE PATIENT DID NOT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL. THE CAUSE OF BREAKAGE OF THE HELICAL BLADE WAS UNKNOWN. IT DOES NOT LOOK AS IF IT BROKE DURING THE CASE WHILE BEING IMPLANTED. INPATIENT FOLLOWS UP THE FRAGMENTS WAS NOTICED. FRAGMENTS LOOKS TO BE A PIECE FROM THE TIP OF THE FENESTRATED HELICAL BLADE. PATIENT FRAGMENTS WERE LOCATED AT THE CENTER OF THE FEMORAL HEAD. THE BROKEN MECHANISM WAS EMBEDDED IN THE PATIENT'S BONE. AS PER THE SURGEON, THE PIECE IS NOT IN OR NEAR THE JOINT SURFACE. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN END CAP (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY# 1), UNKNOWN LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY# 1), UNKNOWN TFNA NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY# 1). THIS IS REPORT 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 8980864 ↗
• InjuryMay 3, 2019Migration; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) BLADE SYSTEM EXPERIENCED A CUTOUT FOR AN INTERTROCHANTERIC FRACTURE. THE SYSTEM HAD USED TRAUMACEM AUGMENTATION BUT STILL EXPERIENCED A CUTOUT. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS REPORT CAPTURES THE SECOND APPLICATION OF TRAUMACEM AUGMENTATION BUT STILL EXPERIENCED A CUTOUT, WHILE RELATED COMPLAINT (B)(4) CAPTURES THE TFNA HELICAL BLADE SYSTEM EXPERIENCED A CUT OUT. CONCOMITANT DEVICES REPORTED: TITANIUM CANNULATED TFNA NAIL (PART# 04.037.042S, LOT#UNKNOWN, QUANTITY 1); TITANIUM LOCKING SCREW STARDRIVER (PART# 04.005.524S, LOT#UNKNOWN, QUANTITY UNKNOWN); TRAUMACEM INJECTABLE BONE CEMENT (PART#07.702.040S, LOT#UNKNOWN, QUANTITY 1); TRAUMACEM INJECTABLE BONE CEMENT (PART# 03.702.150S, LOT#UNKNOWN, QUANTITY 1); TRAUMACEM INJECTABLE BONE CEMENT (PART# 03.702.121S, LOT#UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available

  MAUDE report 8578247 ↗
• InjuryMay 2, 2019Break; Break

  CONCOMITANT DEVICES REPORTED: TITANIUM CANNULATED TFNA NAIL (PART#04.037.042S, LOT#UNKNOWN, QUANTITY 1); TITANIUM LOCKING SCREW STARDRIVER (PART#04.005.524S, LOT#UNKNOWN, QUANTITY UNKNOWN);

  Patient problems: No Code Available

  MAUDE report 8575155 ↗
• InjuryJan 28, 2019No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON IMPLANTED A PROXIMAL FEMORAL NAILING SYSTEM (TFNA) FENESTRATED HELICAL BLADE, TITANIUM LOCKING SCREW WITH T25 STARDRIVE, AND A 130 DEGREES TITANIUM CANNULATED. THE PATIENT DEVELOPED A RASH SHORTLY AFTER THE PROCEDURE. AS OF (B)(6) 2019, THE RASH HAD GONE AWAY. THE SURGICAL DELAY IS UNKNOWN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 95MM - STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Rash

  MAUDE report 8281759 ↗
• 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 BLADE. THIS IS REPORT 3 OF 3 FOR (B)(4).

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

  MAUDE report 8157134 ↗
• InjurySep 12, 2018Migration or Expulsion of Device; Migration; Migration or Expulsion of Device; Migration

  IT WAS REPORTED THAT ON (B)(6) 2018, A TROCHANTERIC FEMORAL NAIL ADVANCE (TFNA) HELICAL BLADE WAS REMOVED DUE TO A CUT OUT IN THE FEMORAL HEAD. IT WAS REPLACED WITH A TFNA SCREW. INITIAL IMPLANT DATE IS UNKNOWN. SURGICAL DELAY AND PATIENT OUTCOME WERE UNKNOWN. CONCOMITANT DEVICES REPORTED: TFNA NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1), DISTAL LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 95MM - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7868551 ↗
• InjuryMay 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT IMPLANT PROCEDURE ON AN UNKNOWN DATE. POST-OPERATIVE, PATIENT COMPLAINED OF PAIN. THE SURGEON PLANNED TO LEAVE THE BLADE IMPLANTED IN THE PATIENT. HOWEVER, WHEN THE PATIENT REPORTED FEELING PAIN, THE SURGEON DECIDED TO EXCHANGE THE BLADE FOR A SMALLER TFNA LAG SCREW. ON (B)(6) 2018, PATIENT UNDERWENT REVISION SURGERY. DURING THE REVISION SURGERY, A BLADE WAS REPLACED WITH A TFNA LAG SCREW OF A SHORTER LENGTH. THE DEVICE WAS SUCCESSFULLY EXCHANGED WITH NO REPORTED DELAY. THE PATIENT WAS REPORTED TO BE IN GREAT CONDITION FOLLOWING THE PROCEDURE. INFORMATION ON IMPLANT PROCEDURE AND THE SURGEON WHO PERFORMED IT IS UNKNOWN. SURGEON WHO PERFORMED REVISION SURGERY WAS REPORTED TO HAVE BEEN AWARE THAT THE PATIENT WAS IMPLANTED WITH A BLADE THAT WAS TOO LONG. IT IS UNKNOWN HOW THE SURGEON WAS MADE AWARE THAT THE IMPLANTED BLADE WAS TOO LONG. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 95MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 7516090 ↗
• InjuryMay 11, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT A FEMORAL FRACTURE PROCEDURE. DURING THE PROCEDURE, A HELICAL BLADE COMPLETELY MISSED THE NAIL. THERE WAS A SURGICAL DELAY OF ABOUT ONE AND A HALF HOUR TO GET THE NAIL OUT AND THE SURGEON HAD TO RE-DO THE PROCEDURE USING A SMALLER DIAMETER NAIL AND A NEW BLADE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO IMPACT TO THE PATIENT. PATIENT OUTCOME WAS REPORTED AS FINE. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 95MM - STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7508647 ↗

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