NA 456.306SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982226747), received between Aug 25, 2017 and Jul 15, 2021 — classified as 2 injuries, 2 malfunctions.

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

• InjuryJul 15, 2021Migration; Migration

  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)11.0MM TI HELICAL BLADE 105MM-STERILE. THIS REPORT IS 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12173673 ↗
• MalfunctionNov 4, 2020Use of Device Problem; Device-Device Incompatibility; Use of Device Problem; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2020 THAT THE PATIENT UNDERWENT FOR IM NAILING OF PROXIMAL FEMUR FIX. DURING THE PROCEDURE, LOCKING MECHANISM DOES NOT FULLY SEATED. PRONG MOST LIKELY DID NOT HAVE ENOUGH SPACE TO PASS INTO BETWEEN GROOVE IN BLADE AND INSIDE WALL OF TFNA NAIL. THE PROCEDURE COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM F/IM NAIL-STER. (PART# 04.005.524S; LOT# 54P3760; QUANTITY: 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) 11.0MM TI HELICAL BLADE 105MM-STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10787497 ↗
• InjuryMay 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) TO TREAT A FEMUR FRACTURE ON AN UNKNOWN DATE. PATIENT WAS IMPLANTED WITH TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) CONSISTING OF A NAIL, HELICAL BLADE AND TWO 5.0MM LOCKING SCREWS. PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2018 TO REMOVE THE TFNA CONSTRUCT AND REPLACE IT WITH A TOTAL HIP DUE TO ARTHRITIS. THERE WAS NO ISSUE WITH THE NAIL, HELICAL BLADE OR LOCKING SCREWS. THE HARDWARE WAS REMOVED WITHOUT INCIDENT OR SURGICAL DELAY. ROUTINE INTRAOPERATIVE X-RAYS STANDARD FOR THE PROCEDURE WERE TAKEN. EXPLANTED HARDWARE WAS DISCARDED BY THE HOSPITAL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT WAS REPORTED AS STABLE. THIS REPORT IS FOR A 11.0MM TI HELICAL BLADE 105MM-STERILE. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Arthritis; No Code Available

  MAUDE report 7554694 ↗
• MalfunctionAug 25, 2017Failure to Align; Failure to Align

  IT WAS REPORT THAT THE PATIENT HAD ORIGINAL SURGERY ON (B)(6) 2017 FOR TREATMENT OF A RIGHT INTERTROCHANTERIC FEMUR FRACTURE. PATIENT WAS IMPLANTED WITH ONE (1) TROCHANTERIC FIXATION LONG NAIL (TFN), ONE (1) 11.0MM TITANIUM (TI) HELICAL BLADE 105MM AND ONE (1) DISTAL LOCKING SCREW. IT WAS REPORTED THAT DURING THE PROCEDURE, AFTER THE SURGEON HAD IMPLANTED THE TFN LONG NAIL, HE NOTED THAT THE HELICAL BLADE WOULD NOT PASS THRU THE IMPLANTED NAIL. SURGEON SWITCHED OUT THE AIMING ARM INSTRUMENT THAT ATTACHED TO THE HELICAL BLADE BUT THE BLADE STILL WOULD NOT LINE UP WITH THE TFN NAIL HOLE. UNANTICIPATED X-RAYS WERE TAKEN. SURGEON CHOSE ANOTHER HELICAL BLADE THAT WAS AVAILABLE IN THE OPERATING ROOM TO COMPLETE THE SURGERY. SURGERY WAS COMPLETED SUCCESSFULLY WITH A 30-MINUTE TIME DELAY. PATIENT IS REPORTED IN STABLE CONDITION. CONCOMITANT DEVICES REPORTED: TFN LONG NAIL (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1), AIMING ARM (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 11.0MM TITANIUM HELICAL BLADE 105MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6820190 ↗

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.