TFN-ADVANCE 04.038.195Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886982098740), received between Nov 2, 2018 and Mar 12, 2026 — classified as 12 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Migration” (3 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryMar 12, 2026Migration

  IT WAS REPORTED THAT THE PATIENT HAD A LATERAL PROTRUSION OF THE LAG SCREW, RESULTING IN HARDWARE REMOVAL AND DEVICE REPLACEMENT. NO FURTHER INFORMATION IS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24581560 ↗
• InjuryJun 23, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT HAD A HARDWARE REMOVAL.

  Patient problems: Insufficient Information

  MAUDE report 22308711 ↗
• InjuryJul 25, 2023Migration; Migration

  IT WAS REPORTED THAT ON JULY 6, 2023, HARDWARE REMOVAL WAS PERFORMED DUE TO LAG SCREW PENETRATION INTO THE JOINT. IT IS UNKNOWN WHEN THE DEVICES WERE IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE TFNA FENESTRATED SCREW 95MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17388418 ↗
• InjuryApr 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE SURGEON REMOVED A TFNA NAIL AND REVISED WITH ANOTHER TFNA NAIL DUE TO NON-UNION. THE SURGEON HAD DIFFICULTIES CONNECTING THE NAIL EXTRACTOR LIKELY DUE TO THE SET SCREW BEING TOO FAR BACK, TOO MUCH SOFT TISSUE INSIDE OF THE NAIL, BLOCKED BY OTHER STRUCTURES FROM BEING COLLINEAR TO ALLOW THE EXTRACTOR TO CONNECT. THE SURGEON CONNECTED THE AIMING ARM FOR EXTRACTION AND IT WAS SUCCESSFULLY REMOVED. THE EXTRACTOR WAS CHECKED POSTOPERATIVELY AND IT DID SUCCESSFULLY CONNECT TO THE NAIL. THERE WAS A SURGICAL DELAY OF FIVE MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS RELATED TO (B)(4). (B)(4): REPORTS THE DEVICE MALFUNCTION THAT OCCURRED DURING EXTRACTION SURGERY. (B)(4): REPORTS POSTOPERATIVE ADVERSE EVENTS AND IMPLANT REMOVAL. THIS REPORT INVOLVES ONE TFNA FENESTRATED SCREW 95MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 16767770 ↗
• MalfunctionApr 13, 2023Device-Device Incompatibility; Device-Device Incompatibility

  THIS REPORT IS RELATED TO (B)(4) . (B)(4) : REPORTS THE DEVICE MALFUNCTION THAT OCCURRED DURING EXTRACTION SURGERY. (B)(4) : REPORTS POSTOPERATIVE ADVERSE EVENTS AND IMPLANT REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16736766 ↗
• InjuryJul 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, THERE WAS REMOVAL OF BROKEN TFNA AND REVISION OF PROXIMAL FEMUR TO NAIL/PLATE HYBRID CONSTRUCT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR A TFNA FENESTRATED SCREW 95MM. THIS IS REPORT 2 OF 4 FOR (B)(4).

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

  MAUDE report 14999998 ↗
• 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) TFNA FENESTRATED SCREW 95MM. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 13713964 ↗
• InjuryFeb 17, 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 PATIENT UNDERWENT A TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA) REMOVAL PROCEDURE FOR AN UNKNOWN REASON. IT WAS NOTED THAT INITIAL IMPLANTATION WAS DONE ON (B)(6) 2021. PATIENT AND PROCEDURE OUTCOME IS UNKNOWN. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 95MM. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

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

  MAUDE report 13552602 ↗
• InjuryDec 13, 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 REVISION DUE TO NON-UNION. THE SURGEON REMOVED A TFNA NAIL AND PLACED A NEW ZIMMER NAIL. THE PATIENT¿S DISTAL FEMUR HAD BEEN REVISED PREVIOUS TO THIS SURGERY. THERE WAS A FIVE (5) MINUTES SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 95MM. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12990410 ↗
• InjuryJun 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN ORTHOPEDIC PROCEDURE, AFTER THE TFNA IMPLANTED ON (B)(6) 2021, THE FEMUR WAS BROKEN BELOW DISTAL INTERLOCKING SCREW IN NAIL. NAIL, LAG SCREW, AND DISTAL INTERLOCKING SCREW WERE REMOVED ON (B)(6) 2021 AND SWAPPED OUT WITH NEW TFNA EXCHANGE NAIL, LAG SCREW AND NEW INTERLOCKING SCREW DISTALLY. THE PROCEDURE SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 95MM. THIS REPORT IS 2 OF 3 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 12060538 ↗
• InjuryApr 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021, THE PATIENT UNDERWENT REMOVAL OF PROXIMAL FEMORAL NAILING SYSTEM (TFNA) NAIL, TFNA FENESTRATED SCREW AND UNKNOWN LOCKING SCREW DUE TO NONUNION. WHILE TRYING TO UNLOCK THE TFNA FENESTRATED SCREW THE FLEXIBLE HEXAGONAL SCREWDRIVER BROKE. ALL THE IMPLANTED DEVICES ARE REMOVED. PATIENT OUTCOME WAS SUCCESSFUL. THIS REPORT CAPTURES THE POSTOP EVENT OF HARDWARE REMOVAL DUE TO NONUNION AND RELATED COMPLAINT (B)(4) CAPTURES THE INTRAOP EVENT OF SCREWDRIVER BREAKAGE DURING REMOVAL. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 95MM. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11756441 ↗
• MalfunctionOct 2, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PROXIMAL FEMORAL NAILING SYSTEM (TFNA) LAG SCREW WAS STUCK/WEDGED ONTO THE HELICAL BLADE/SCREW EXTRACTOR. THE SCREW CANNOT BE REMOVED FROM THE INSTRUMENT. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR A TFNA FENESTRATED SCREW 95MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10622920 ↗
• InjurySep 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, A HARDWARE REMOVAL WAS PERFORMED DUE TO NONUNION. THE SURGEON REMOVED ALL TFNA PARTS AND REPLACED WITH ZIMMER NAIL. OTHER INTERVENTIONS REQUIRED REMOVAL SURGERY, REVISION, RIA ON THE CONTRALATERAL FEMUR FOR A BONE GRAFT. LESS THAN DESIRABLE OUTCOME NONUNION AND DELAYED HEALING. THE ORIGINAL DATE OF IMPLANTATION WAS ON (B)(6) 2020. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS OUTCOME TFNA REMOVED. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) TFNA FENESTRATED SCREW 95MM. THIS IS REPORT 2 OF 3 (B)(4).

  Patient problems: No Code Available

  MAUDE report 10547551 ↗
• InjuryNov 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT OUTCOME WAS SATISFACTORY.

  Patient problems: No Code Available

  MAUDE report 8032389 ↗

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