NA 456.318SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982226938), received between Nov 28, 2018 and Feb 10, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2026Use of Device Problem

  IT WAS REPORTED THAT TFN Ø11 SHORT 130° L170 TAN GREEN WAS USED IN AN EVENT WHERE AN INCORRECT OLDER TFN NAIL WAS USED IN CONJUNCTION WITH A NEWER TFN-A HELICAL BLADE CONSTRUCT DURING A PROCEDURE. THE OLDER NAIL AND THE NEWER HELICAL BLADE CONSTRUCT WERE BOTH IMPLANTED. THE NURSE AND SURGEON INDICATED THAT THE PROCEDURE WENT SMOOTHLY AND THE CONSTRUCTS FIT WELL. THERE WAS NO REPORTED CONSEQUENCE OR IMPACT TO THE PATIENT, AND NO SIGNS, SYMPTOMS, OR PATIENT INVOLVEMENT WERE OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24303913 ↗
• MalfunctionAug 27, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A PROCEDURE, NAIL WOULD NOT PROPERLY THREAD ONTO CONNECTING SCREW AND INSERTION HANDLE. SURGEON HAD TO OPEN A NEW NAIL IN ORDER TO ENSURE THE NAIL COULD BE IMPLANTED PROPERLY. NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR 1 11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12380165 ↗
• InjuryJul 15, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT FOR A REVISION SURGERY. DURING THE SURGERY, THE SURGEON REPLACED A NEW TFN, HELICAL BLADE AND LOCKING SCREW. DUE TO LOSE OF HELICAL BLADE INSIDE THE NAIL, WHICH WAS CAUSING THE CUT OUT. IT WAS UNKNOWN IF THE REVISION SURGERY COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. CONCOMITANT DEVICE REPORTED: 170MM TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL: (PART# 456.318S; LOT# UNKNOWN; QUANTITY: 1). LOCKING SCREW 5.0MM (PART# 04.005.526S; LOT# UNKNOWN; QUANTITY: 1). THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) 11/130 DG TI CAN TROCH FIXATN NL 170-S. THIS REPORT IS 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12173645 ↗
• MalfunctionNov 13, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2020, A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL WAS FOUND TO HAVE A DEFECT. THERE WAS A PIECE INSIDE THE HOLE IN THE NAIL. THE NAIL WAS INSIDE THE PATIENT WHEN THE ISSUE WAS DISCOVERED. THE SURGEON TOOK THE NAIL OUT AND REALIZED THE PROBLEM, THEN OPENED UP A NEW IMPLANT. THERE WAS A SURGICAL DELAY OF TWENTY (20) MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS STABLE FOLLOWING PROCEDURE. THIS REPORT IS FOR ONE (1) 11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10837806 ↗
• 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) 11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8531350 ↗
• InjuryNov 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A REMOVAL OF ALL TROCHANTERIC FIXATION NAIL (TFN) HARDWARE ON (B)(6) 2018 DUE TO PAIN IN THE HIP AREA. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN OPEN REDUCTION OF THE RIGHT HIP AND WAS ORIGINALLY IMPLANTED WITH A (TFN) SHORT NAIL. ALL HARDWARE WERE REMOVED SUCCESSFULLY WITH NO COMPLICATIONS OR EXTENDED TIME NEEDED. THE SURGEON IMPLANTED A TENSION BAND PLATE AFTER HARDWARE REMOVAL TO SUPPLY ADDITIONAL STRENGTH TO THE RIGHT HIP. HARDWARE WAS ALL INTACT. PATIENT OUTCOME UNKNOWN. THIS COMPLAINT IS FOR ONE (1) 11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS 1 OF 3 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 8113186 ↗

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.