NA 456.322SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982226969), received between Apr 25, 2018 and Feb 11, 2022 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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.

• InjuryFeb 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, PATIENT UNDERWENT A HARDWARE REMOVAL AND REVISION SURGERY. THERE WAS A FRACTURE THAT OCCURRED BELOW THE NAIL. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR A 12MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE. THIS IS REPORT 3 OF 3 FOR PC-(B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 13518401 ↗
• InjurySep 10, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING INSERTION OF CANNULATED TROCHANTERIC FIXATION NAIL (TFN), DIFFICULTY WAS ENCOUNTERED UPON DRILLING THROUGH THE 130-DEGREE AIMING ARM. THE DRILL BIT COLLIDED WITH THE TFN IMPLANT. THE RESULT WAS ADDITIONAL DRILL HOLES IN THE FEMUR. THE PROCEDURE WAS EXTENDED APPROXIMATELY 20 MINUTES. ADDITIONAL C-ARM TIME WAS REQUIRED. THE LOCKING SCREW WAS SUCCESSFULLY INSERTED IN THE LOCKING OPTION. THE INNER DRILL SLEEVES WERE REMOVED, AND THE DRILL BIT WAS THEN USED TO DRILL THROUGH BOTH CORTICES IN A FREEHAND TECHNIQUE. THERE WERE NO FRAGMENTS GENERATED. THERE WAS A SURGICAL DELAY APPROXIMATELY TWENTY (20) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN LOCKING SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS IS REPORT 4 FOR 5 (B)(4).

  Patient problems: Injury

  MAUDE report 8983856 ↗
• InjuryJan 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT HARDWARE REMOVAL DUE TO INFECTION OF THE HIP. DURING THE REMOVAL, THE TITANIUM TROCHANTERIC FIXATION NAIL SCREW, TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL, AND TITANIUM LOCKING SCREW WITH T25 STARDRIVE WERE REMOVED. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR ONE (1) TITANIUM TROCHANTERIC FIXATION NAIL. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8232414 ↗
• MalfunctionApr 25, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT A TROCHANTERIC FIXATION NAIL (TFN) NAIL MALFUNCTIONED DURING A PATIENT PROCEDURE ON (B)(6) 2018 THAT WAS PERFORMED TO TREAT AN INTERTROCHANTERIC FRACTURE. DURING THE PROCEDURE AFTER ALIGNMENT OF THE TFN NAIL WITH THE INSERTION HANDLE, THE INTERNAL LOCKING MECHANISM IN THE TFN NAIL WAS SEATED TOO HIGH IN THE DEVICE AND WOULD NOT ADVANCE. THE THREADS ON THE TFN NAIL BECAME STRIPPED AFTER THE CONNECTING SCREW WAS PASSED THROUGH THE INSERTION HANDLE TO MATE WITH THE TFN NAIL. SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE TO MATE THE CONNECTING SCREW WITH THE TFN NAIL WHICH RESULTED IN A 5-7 MINUTE SURGICAL DELAY. THERE WAS A SIMILAR BACK-UP IMPLANT OF THE SAME SIZE THAT WAS USED TO COMPLETE THE PROCEDURE. NO HARM WAS REPORTED TO THE PATIENT. PATIENT OUTCOME WAS REPORTED FINE. NO MALFUNCTIONS WERE AGAINST THE INSERTION HANDLE OR COUPLING SCREW. CONCOMITANT DEVICES REPORTED: INSERTION HANDLE (UNKNOWN PART AND LOT NUMBERS, QUANTITY: 1), CONNECTING SCREW (UNKNOWN PART AND LOT NUMBERS, QUANTITY: 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7462356 ↗

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.