NA 456.420SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982227867), received between May 30, 2018 and Aug 27, 2020 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• 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: 11.0MM TI HELICAL BLADE 100MM (PART NUMBER 456.305, 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: HAMMER/MALLET: TR (PART NUM

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10460184 ↗
• InjuryMay 27, 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 OF A TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL DUE TO NON-UNION. THE TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL WAS REMOVED WITH NO ISSUES AND A TOTAL HIP ARTHROPLASTY WAS PERFORMED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10093146 ↗
• InjuryJul 16, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE A BROKEN TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL AND DISTAL SCREW. THE PATIENT REPORTED ALSO EXPERIENCED HIP PAIN AND NON-UNION. THE NAIL HAD BROKEN INTO TWO (2) PIECES. ALL BROKEN PIECES OF BOTH DEVICES WERE RETRIEVED AND REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. ORIGINAL IMPLANT DATE WAS UNKNOWN. PATIENT WAS REVISED TO A TOTAL HIP REPLACEMENT. THE REMOVAL OF THE NAIL TOOK APPROXIMATELY FORTY-FIVE (45) MINUTES BEFORE THE SURGEON COULD BEGIN THE HIP ARTHROPLASTY. IT WAS NOTED THE REMOVAL PROCEDURE WAS CHALLENGING BUT UNEVENTFUL AND THE PATIENT OUTCOME WAS REPORTED AS STABLE. CONCOMITANT DEVICE/S REPORTED: HELICAL BLADE (PART 456.305, LOT H390536, QUANTITY 1). THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 7689913 ↗
• 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 11MM/130 DEG TI CANN TROCH FIXATION NAIL 400MM/RIGHT-STER. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Arthritis; No Code Available

  MAUDE report 7554706 ↗

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.