NA 456.305Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982226716), received between Feb 6, 2017 and Nov 30, 2021 — classified as 8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryNov 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A HARDWARE REMOVAL OF TFN ORIGINAL IN PREPARATION FOR TOTAL HIP ARTHROPLASTY(THA). THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS COMPLAINT INVOLVES UNKNOWN NUMBER OF DEVICES. THIS REPORT IS FOR (1) 11.0MM TI HELICAL BLADE 100MM. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 12894255 ↗
• MalfunctionAug 27, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON WAS PUTTING A 100MM TITANIUM HELICAL BLADE INTO A TROCHANTERIC FIXATION (TFN) NAIL. THE HELICAL BLADE WAS HALFWAY IN AND IT WOULD NOT ADVANCE OR COULD NOT GET IT BACK OUT. THE SURGEON VERIFIED THE SIDE ARM WAS AT THE SAME ANGLE AS THE NAIL AND VERIFIED THAT THE ANTI-ROTATION MECHANISM WAS NOT INTERFERING WITH THE HELICAL BLADE. THE HELICAL BLADE INSERTION HANDLE WAS REMOVED. THE BLADE WAS EASILY REMOVED WITH THE SLAP HAMMER. THE SURGEON ELECTED TO REMOVE THE NAIL AND REPLACED IT WITH A NEW NAIL. THE HELICAL BLADE WAS ALSO REPLACED WITH A NEW ONE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADDITION COMPLICATIONS. THE NURSE HAD STATED THAT THE NAIL WAS REPROCESSED AT THE HOSPITAL BECAUSE IT WAS OPENED IN A PRIOR CASE BY ACCIDENT. NO X-RAYS ARE AVAILABLE. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICES REPORTED: 11MM/130 DEG TI CANN TROCH FIXATION NAIL 400MM/RIGHT-STER (PART NUMBER 456.420S, LOT UNKNOWN, QUANTITY 1), EXTRACTION INSTRUMENTS: CMF (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), INSERTION INSTRUMENTS: TRAUMA (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), IMPACTION INST

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10460226 ↗
• InjuryMay 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10093145 ↗
• InjuryMay 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REMOVAL/REVISION OF 1 TITANIUM HELICAL BLADE, 1 TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL, 1 END CAP AND 2 LOCKING SCREWS FOR TOTAL HIP REPLACEMENT DUE TO NON-UNION. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 10051205 ↗
• InjuryFeb 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT UNDERWENT THE REMOVAL OF BILATERAL TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAILS IN BOTH RIGHT AND LEFT LEGS DUE TO NON-UNION AND INFECTION. FOR THE RIGHT LEG, ONE (1) TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL, ONE (1) HELICAL BLADE, AND TWO (2) UNKNOWN 5.0MM SCREWS WERE REMOVED. FOR THE LEFT LEG, ONE (1) TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL, ONE (1) END CAP, ONE (1) HELICAL BLADE, AND ONE (1) UNKNOWN 5.0MM SCREW WERE REMOVED. THE RIGHT LIMB INCURRED A SECONDARY FRACTURE OF THE PROXIMAL FEMUR UPON THE NAIL REMOVAL. THIS FRACTURE WILL BE ADDRESSED AT A LATER DATE. THERE WAS NO SURGICAL DELAY. THE DEVICES WERE REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 11.0MM TI HELICAL BLADE 100MM. THIS IS REPORT 6 OF 8 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9662133 ↗
• InjuryFeb 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT UNDERWENT THE REMOVAL OF BILATERAL TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAILS IN BOTH RIGHT AND LEFT LEGS DUE TO NON-UNION AND INFECTION. FOR THE RIGHT LEG, ONE (1) TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL, ONE (1) HELICAL BLADE, AND TWO (2) UNKNOWN 5.0MM SCREWS WERE REMOVED. FOR THE LEFT LEG, ONE (1) TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL, ONE (1) END CAP, ONE (1) HELICAL BLADE, AND ONE (1) UNKNOWN 5.0MM SCREW WERE REMOVED. THE RIGHT LIMB INCURRED A SECONDARY FRACTURE OF THE PROXIMAL FEMUR UPON THE NAIL REMOVAL. THIS FRACTURE WILL BE ADDRESSED AT A LATER DATE. THERE WAS NO SURGICAL DELAY. THE DEVICES WERE REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 11.0MM TI HELICAL BLADE 100MM. THIS IS REPORT 2 OF 8 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9661559 ↗
• InjuryOct 30, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF A TROCHANTERIC FIXATION NAIL (TFN) NAIL DUE TO TOTAL HIP REPLACEMENT. A CONICAL EXTRACTION BOLT AND THE TIP OF A HELICAL BLADE/SCREW EXTRACTOR BROKE WHILE TRYING TO REMOVE THE IM NAIL. IT WAS MENTIONED THAT THE IM NAIL WAS NOT REMOVED FOR A COUPLE OF HOURS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A TWO (2) HOURS SURGICAL DELAY. THE PATIENT STATUS WAS FINE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# / LOT# UNKNOWN, QUANTITY: UNKNOWN); THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) 11.0MM TI HELICAL BLADE 100MM THIS IS REPORT IS 4 OF 4 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9257979 ↗
• InjuryJul 11, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT APPROXIMATELY SIX WEEKS PRIOR TO REMOVAL, THE PATIENT WAS IMPLANTED WITH A SHORT TROCHANTERIC FIXATION NAIL (TFN), HELICAL BLADE, AND DISTAL LOCKING SCREW FOR REPAIR OF A HIP FRACTURE. PATIENT LATER PRESENTED WITH HIP PAIN. SUBSEQUENT X-RAY TAKEN ON UNKNOWN DATE SHOWED THAT THE FEMORAL HEAD HAD COLLAPSED AND THE HELICAL BLADE WAS JUST STARTING TO PROTRUDE THROUGH THE FEMORAL HEAD. ON (B)(6) 2018, THE 100MM HELICAL BLADE WAS REMOVED AND REPLACED WITH 85MM HELICAL BLADE. HOWEVER, THE NAIL AND DISTAL LOCKING SCREW REMAINED IMPLANTED IN THE PATIENT AS THERE WAS NO ISSUE WITH THESE TWO (2) DEVICES. NO SURGICAL DELAY OR PATIENT CONSEQUENCE WAS REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: SHORT TFN NAIL (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1); DISTAL LOCKING SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 11.0MM HELICAL BLADE 100MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 7678234 ↗
• InjuryFeb 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 AFTER A TROCHANTERIC FIXATION NAIL (TFN) AND HELICAL BLADE MIGRATED. ON AN UNKNOWN DATE, A PATIENT WITH POOR BONE QUALITY (OSTEOPOROSIS) WAS ORIGINALLY IMPLANTED WITH A TFN, HELICAL BLADE AND LOCKING BOLT TO TREAT A RIGHT HIP FRACTURE. SUBSEQUENTLY, THE PATIENT FELL. X-RAY ON AN UNKNOWN DATE SHOWED LATERAL MOVEMENT OF THE TFN AND HELICAL BLADE AND BREAKAGE OF THE LATERAL CORTEX OF THE BONE. ON (B)(6) 2017, THE TFN, HELICAL BLADE AND LOCKING BOLT WERE EXPLANTED AND THE PATIENT WAS REVISED TO A SIX-HOLE 4.5 MILLIMETER LOCKING COMPRESSION PLATE PROXIMAL FEMUR PLATE AND SCREWS AND CHRONOS BONE VOID FILLER. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS REPORTED AS STABLE. THIS IS REPORT 2 OF 3 FOR (B)(4).

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

  MAUDE report 6303482 ↗

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.