NA 456.304SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982226709), received between Dec 19, 2017 and Apr 19, 2019 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, THERE WAS DIFFICULTY GETTING THE HELICAL BLADE TO PASS THROUGH THE NAIL. THE BLADE WAS HITTING THE BOTTOM OF THE NAIL. IT WAS AS IF THE NAIL WAS A 135 AS OPPOSED TO 130. THE SURGEON THEN TRIED TIGHTENING THE NAIL CONNECTION TO THE INSERTION HANDLE. THE BLADE GUIDE SLEEVE CONNECTION TO THE NAIL INSERTION HANDLE WAS ALSO TIGHT. THE BLADE WAS ABLE TO PASS MANUALLY WITH THE BLADE GUIDE SLEEVE AND DISCONNECTING THE COMPRESSION NUT FROM THE AIMING ARM. THE NAIL WAS LOCKED DISTALLY THROUGH THE LOVING SLEEVES AND FINISHED THE CASE. THE ORIGINAL BLADE WAS REMOVED AND TRIED IMPLANTED A SECOND SET OF HELICAL BLADE. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A TEN (10) MINUTE SURGICAL DELAY. PATIENT OUTCOME WAS GOOD. CONCOMITANT DEVICES REPORTED: UNKNOWN INSERTION HANDLE (PART#UNKNOWN, LOT#UNKNOWN, QUANTITY 1), UNKNOWN GUIDE SLEEVE (PART#UNKNOWN, LOT#UNKNOWN, QUANTITY 1), UNKNOWN AIMING ARM (PART#UNKNOWN, LOT#UNKNOWN, QUANTITY 1), UNKNOWN COMPRESSION NUT (PART#UNKNOWN, LOT#UNKNOWN, QUANTITY 1) THIS REPORT IS FOR ONE (1) 11.0MM TI HELICAL BLADE 95MM-STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8531351 ↗
• MalfunctionDec 17, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A HIP SURGERY ON (B)(6) 2018, THE HELICAL BLADE DID NOT INSERT THROUGH THE TROCHANTERIC FIXATION NAIL (TFN) NAIL CONGRUENTLY. THE SURGEON REMOVED THE NAIL AND IMPLANTED ANOTHER NAIL WITH A NEW HELICAL BLADE. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8171775 ↗
• InjuryFeb 6, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A HARDWARE REMOVAL AND REVISION OF A TROCHANTERIC FIXATION NAIL (TFN) WAS PERFORMED ON (B)(6) 2018 DUE TO NON-UNION AND HELICAL BLADE CUT-OUT OF THE SUPERIOR PORTION OF THE FEMORAL HEAD. THE ORIGINAL TFN PROCEDURE WAS PERFORMED ON (B)(6) 2016 BY A DIFFERENT SURGEON AT A DIFFERENT FACILITY. ALL TFN IMPLANTS WERE REMOVED INTACT AND WITHOUT INCIDENT. THE PATIENT WAS REVISED TO A BIOMET TOTAL HIP SYSTEM. SURGERY WAS COMPLETED SUCCESSFULLY AND PATIENT OUTCOME WAS SATISFACTORY. THIS COMPLAINT INVOLVES ONE PART. THIS REPORT IS 1 OF 1 FOR (B)(4).

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

  MAUDE report 7244277 ↗
• MalfunctionDec 19, 2017Sticking; Sticking

  IT WAS REPORTED A PATIENT HAD INITIAL SURGERY ON (B)(6) 2017 FOR TREATMENT OF A SUB-TROCHANTERIC FEMUR FRACTURE. PATIENT WAS IMPLANTED WITH ONE (1) TROCHANTERIC FIXATION NAIL (TFN), ONE (1) 11.0 MM TI HELICAL BLADE AND ONE (1) 4.5 MM DISTAL LOCKING SCREW. AS THE SURGEON WAS USING THE SLIDE HAMMER WHILE INSERTING THE HELICAL BLADE IMPLANT WITH THE HELICAL BLADE COUPLING SCREW, THE DISTAL KNOB ON THE COUPLING SCREW BROKE OFF INTRAOPERATIVELY, AND FELL ON THE OPERATING ROOM FLOOR. DUE TO THE FORCE THAT THE SURGEON USED TO DISENGAGE THE HELICAL BLADE IMPLANT FROM THE TFN INSTRUMENTS, THE AIMING ARM INSTRUMENT AND THE HELICAL BLADE INSERTER INSTRUMENT BECAME WARPED. ALSO, THE BUTTRESS COMPRESSION NUT BECAME STUCK INSIDE THE BLADE GUIDE SLEEVE. THE SURGEON SUCCESSFULLY DISENGAGED ALL THE INSTRUMENTS FROM THE IMPLANT, AND PROCEEDED WITH THE SURGERY. NO FRAGMENTS WERE GENERATED. SURGERY WAS COMPLETED SUCCESSFULLY WITH 30-40-MINUTE TIME DELAY. PATIENT IS REPORTED IN STABLE CONDITION. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7127997 ↗

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-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-0452-2014 · Jul 30, 2013 · Terminated
  Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of the proximal femur.
• Z-2058-2013 · Nov 2, 2012 · Terminated
  Synthes Trauma Nail System. The devices are indication for bone fixation.