NA 456.306Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982226730), received between Apr 24, 2018 and Sep 20, 2019 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

7 other recalls cover devices cleared under the same FDA submission (K011857); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A TROCHANTERIC FEMORAL NAIL PROCEDURE, THE LOCKING MECHANISM THAT ROTATIONALLY LOCKS THE HELICAL BLADE OR LAG SCREW FELL DOWN INTO THE NAIL DURING THE OPERATION BEFORE IT WAS SUPPOSED TO. THE FOLLOWING ARE THE DEVICES USED DURING THE INSERTION OF THE HELICAL BLADE: UNKNOWN HELICAL BLADE INSERTION HANDLE, UNKNOWN CONNECTING SCREW, AIMING ARM, OUTER SLEEVE THROUGH THE AIMING ARM. WHILE INSERTING THE HELICAL BLADE, THE BLADE GOT STUCK HALFWAY BETWEEN FULLY INSERTED AND COMING OUT, AND UNABLE TO EXTRACT THE HELICAL BLADE OR ADVANCE IT FORWARD BECAUSE IT¿S A LITTLE TOO IN THE LOCKING MECHANISM BROKE OFF AND GOT LEDGE IN BETWEEN THE HELICAL BLADE AND THE NAIL ITSELF IN THE MIDDLE. THERE WAS A BACKUP DEVICE USED, THE NAIL AND HELICAL BLADE WERE REMOVED AND A NEW NAIL AND BLADE WERE USED. THERE WAS A DIFFICULTY IN THE REMOVAL. THE DOCTOR ATTEMPTED TO USE STANDARD TFN EXTRACTION INSTRUMENTATION BUT WAS UNSUCCESSFUL AS THE HELICAL BLADE WAS NOT ABLE TO BE REMOVED INDEPENDENTLY FROM THE NAIL. EVENTUALLY, HE EXTRACTED BOTH THE NAIL AND BLADE OUT TOGETHER. THE FOLLOWING ARE THE DEVICES USED IN THE CASE BUT ARE UNABLE TO DISASSEMBLE THEM

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9099898 ↗
• InjuryMar 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, A PATIENT UNDERWENT A REVISION PROCEDURE DUE TO A NONUNION OF A PERTROCHANTERIC FRACTURE AND A FRACTURED LONG TITANIUM TROCHANTERIC FIXATION NAIL (TFN) THROUGH THE HELICAL BLADE HOLE DUE TO THE NONUNION. BROKEN IMPLANTS WERE REMOVED WITHOUT EVENT AND THE PATIENT¿S FRACTURE WAS TREATED WITH A 6 HOLE DHS PLATE 140 DEGREE. VIVIGEN FORMABLE-15CC AND NORIAN DRILLABLE-5CC WERE USED IN THE REVISION. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PATIENT DEVELOPED AN INFECTION AFTER INITIAL SURGERY AND REQUIRED MANY ¿WASHOUTS¿ PRIOR TO THE NONUNION AND NAIL FAILURE. PATIENT'S ACTIVITY LEVEL WAS REPORTED AS AMBULATORY. PATIENT AND SURGERY OUTCOME WERE NOT REPORTED. THIS REPORT IS FOR ONE (1) TI HELICAL BLADE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8437398 ↗
• InjuryMar 6, 2019Migration; Migration

  CONCOMITANT DEVICES REPORTED: TITANIUM CANNULATED TROCHANTERIC NAIL (PART#: 456.414, LOT#: 6868971, QUANTITY: 1), UNKNOWN LOCKING SCREW (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1).

  Patient problems: Bone Fracture(s); Impaired Healing

  MAUDE report 8394241 ↗
• InjuryMay 29, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT DURING A HARDWARE REMOVAL PROCEDURE ON (B)(6) 2018, A TITANIUM HELICAL BLADE 105 MM WAS CUT OUT. THE HELICAL BLADE HAD CUT THROUGH THE FEMORAL HEAD. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICES: 12MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE (PART: 456.322S, LOT: UNKNOWN, QUANTITY: 1), 5.0MM TI LOCKING SCREW 38MM-FOR IM NAILS (PART: 458.938, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A 11.0MM TI HELICAL BLADE 105MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7549779 ↗
• InjuryApr 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A TROCHANTERIC FEMORAL NAIL (TFN) IN 2016. THE PATIENT SUFFERED FROM VARIOUS ILLNESS AND IS ADVANCED IN AGE. DUE TO INFECTION, THE PATIENT UNDERWENT A REMOVAL SURGERY ON (B)(6) 2018. IT WAS REPORTED THAT THE TFN NAIL, HELICAL BLADE AND A 5.0 LOCKING SCREW WERE REMOVED AND NOTHING WAS REPLACED. IT WAS ALSO REPORTED THAT AT THE END OF THE PROCEDURE THERE WAS A COMPLETE IRRIGATION OF THE INFECTED AREA WHICH WAS THE ENTIRE LEFT LEG OF THE PATIENT. THERE WERE LABORATORY CULTURE TESTS TAKEN DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. THE PATIENT OUTCOME IS UNKNOWN. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR ONE (1) 11.0MM TI HELICAL BLADE 105MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7454234 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K011857. One submission often covers many models, so check the product and lot details in each record.

• Z-0604-2018 · Jul 21, 2017 · Terminated
  11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile
• Z-0375-2016 · Nov 2, 2015 · Terminated
  Trochanteric Fixation Nail- Advanced System-11MM/130 DEG TI CANN TFNA 420MM/Right Sterile (The TFN-ADVANCED Proximal Femoral Nailing System) The TFN-ADVANCED Proximal Femoral Naili
• Z-0219-2015 · Oct 29, 2014 · Terminated
  10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the proximal femur
• Z-0387-2014 · Jul 31, 2013 · Terminated
  Large Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes Large Buttress Compression Nut For Blade Guide Sleeve TFN is intended to treat stable and unstable pertrocha
• Z-0452-2014 · Jul 30, 2013 · Terminated
  Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of the proximal femur.
• Z-0474-2014 · Jul 30, 2013 · Terminated
  Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is intended to treat stable and unstable fractures of the proximal
• Z-2058-2013 · Nov 2, 2012 · Terminated
  Synthes Trauma Nail System. The devices are indication for bone fixation.