NA 456.303Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982226679), received between Jun 11, 2014 and Nov 12, 2019 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 12, 2019Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL OF TITANIUM TROCHANTERIC FIXATION NAIL (TFN)  DUE TO HELICAL BLADE PENETRATING THROUGH FEMORAL HEAD RESULTING TO TOTAL HIP ARTHROPLASTY (THA). PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: TFN - TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL (PART # 456.328S, LOT # H107691, QUANTITY 1), UNKNOWN SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Code Available

  MAUDE report 9311743 ↗
• MalfunctionJun 21, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING A ROUTINE INCOMING INSPECTION OF LOANER SET, THE HELICAL BLADE WAS OBSERVED DAMAGED. THERE WAS NO KNOWN HOSPITAL OR PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 11.0 MM TI HELICAL BLADE 90 MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8724655 ↗
• InjuryJan 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH AN UNKNOWN SYNTHES TROCHANTERIC FIXATION NAIL (TFN) AND A SYNTHES 11.0MM TITANIUM (TI) HELICAL BLADE 90MM LENGTH ON AN UNKNOWN DATE APPROXIMATELY 2 YEARS AGO TO TREAT AN UNKNOWN FRACTURE. ON AN UNKNOWN DATE POSTOPERATIVELY, THE PATIENT PRESENTED WITH PAIN. THE PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2017, WHERE AN ACTIVE INFECTION WAS IDENTIFIED AND WHERE THE IMPLANTED DEVICES WERE REMOVED INTACT AND WITHOUT DIFFICULTY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS REPORTED IN STABLE CONDITION. THIS REPORT IS FOR ONE (1) 11.0MM TI HELICAL BLADE 90MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 7189421 ↗
• InjuryDec 29, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT PATIENT HAD A REVISION ON (B)(6) 2017, DUE TO HELICAL BLADE WAS STICKING OUT. PATIENT WAS IMPLANTED WITH TROCHANTERIC FIXATION NAIL, DATE UNKNOWN. PATIENT BEGAN TO HAVE PAIN OF THE HIP AT THE JOINT, X-RAY WAS TAKEN, DATE UNKNOWN, IT WAS NOTICED THAT THE HELICAL BLADE WAS STICKING OUT SIGNIFICANTLY LATERAL BECAUSE THE BONE HAD COLLAPSED. IT WAS REPORTED THAT THE DEVICE FUNCTIONED CORRECTLY BY SLIDING AND NOT CUTTING OUT THE FEMORAL HEAD, BUT CAUSED THE PATIENT PAIN ON THE LATERAL SIDE OF THE HIP. HELICAL BLADE WAS REMOVED AND A SHORTER WAS IMPLANTED. CONCOMITANT DEVICE(S) REPORTED: TFN NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1) . THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR 1 (ONE) HELICAL BLADE. (B)(4).

  Patient problems: Injury; Pain

  MAUDE report 7154480 ↗
• InjuryNov 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017 TO REMOVE A TROCHANTERIC FIXATION NAIL (TFN) SYSTEM FOR A CONVERSION TO A TOTAL HIP REPLACEMENT. THE PATIENT WAS INITIALLY IMPLANTED ON AN UNKNOWN DATE. POST-OPERATIVELY THE PATIENT HAD FALLEN AND BROKE HER FEMUR AGAIN. CABLES WERE IMPLANTED TO HOLD THE BONE TOGETHER BEFORE REMOVAL OF NAIL, THEN CONTINUED ON TO COMPLETE THE HIP REPLACEMENT. DURING THE REVISION THE TFN NAIL, HELICAL BLADE, LOCKING SCREW AND END CAP WERE EASILY REMOVED, WHOLE AND INTACT. THERE WAS NO SURGICAL DELAY. NO PATIENT HARM WAS REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO DEVICE MALFUNCTIONS OCCURRED DURING THE REVISION. THE PATIENT RECEIVED A TOTAL HIP REPLACEMENT. PATIENT OUTCOME WAS REPORTED AS STABLE. THIS REPORT IS FOR ONE (1) 11.0 MM TI HELICAL BLADE 90 MM. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 7002809 ↗
• MalfunctionMar 31, 2017Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE DURING A TROCHANTERIC FIXATION NAIL (TFN) PROCEDURE, THE HELICAL BLADE WOULD NOT GO THROUGH THE NAIL. AS THE BLADE WAS BEING HAMMERED IT WOULD NOT GO IN THROUGH THE NAIL. THE SURGEON REMOVED THE BLADE AND NAIL AND TRIED THE BLADE/NAIL INSERTION AT THE BACK TABLE AND AGAIN IT WOULD NOT WORK. IT WAS DISCOVERED THAT THE AIMING ARM BEING USED WAS INCORRECT. THE NAIL IS A 130 DEGREE NAIL AND THE AIMING ARM USED WAS 125 DEGREE AIMING ARM. THE SURGEON DID NOT WANT TO USE THE SAME IMPLANTS AS HE BELIEVED THEY WERE DAMAGED DURING THE FAILED BLADE INSERTION ATTEMPT. A NEW NAIL AND BLADE WERE USED TO COMPLETE THE PROCEDURE. THE REPORTED EVENT RESULTED IN A 10 MINUTE SURGICAL DELAY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO HARM TO THE PATIENT. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6449378 ↗
• InjuryJun 11, 2014Fracture; Migration or Expulsion of Device; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A PATIENT HAD A TROCHANTERIC FIXATION NAIL (TFN) PLACED ON (B)(6) 2014 TO TREAT AN ILIOTIBIAL TRACT (IT) FRACTURE. THE FRACTURE COLLAPSED AND THE HELICAL BLADE STARTED TO CUT OUT SUPERIOR AND MEDIAL IN THE FEMORAL HEAD. THE HELICAL BLADE WAS REMOVED AND REPLACED WITH A SHORTER LAG SCREW. THIS WAS A SURGICAL REVISION. THE PROCEDURE WAS SUCCESSFUL; HOWEVER THE PATIENT STATUS/OUTCOME IS UNKNOWN. THERE WAS NO REPORT OF A SURGICAL DELAY. THIS REPORT IS 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; No Code Available

  MAUDE report 3866844 ↗

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.