NA 456.418SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982227843), received between Oct 16, 2018 and Sep 20, 2019 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 20, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A TROCHANTERIC FEMORAL NAIL PROCEDURE, THE LOCKING MECHANISM THAT ROTATIONALLY LOCKS THE HELICAL BLADE OR LAG SCREW FELL DOWN INTO THE NAIL DURING THE OPERATION BEFORE IT WAS SUPPOSED TO. THE FOLLOWING ARE THE DEVICES USED DURING THE INSERTION OF THE HELICAL BLADE: UNKNOWN HELICAL BLADE INSERTION HANDLE, UNKNOWN CONNECTING SCREW, AIMING ARM, OUTER SLEEVE THROUGH THE AIMING ARM. WHILE INSERTING THE HELICAL BLADE, THE BLADE GOT STUCK HALFWAY BETWEEN FULLY INSERTED AND COMING OUT, AND UNABLE TO EXTRACT THE HELICAL BLADE OR ADVANCE IT FORWARD BECAUSE IT¿S A LITTLE TOO IN THE LOCKING MECHANISM BROKE OFF AND GOT LEDGE IN BETWEEN THE HELICAL BLADE AND THE NAIL ITSELF IN THE MIDDLE. THERE WAS A BACKUP DEVICE USED, THE NAIL AND HELICAL BLADE WERE REMOVED AND A NEW NAIL AND BLADE WERE USED. THERE WAS A DIFFICULTY IN THE REMOVAL. THE DOCTOR ATTEMPTED TO USE STANDARD TFN EXTRACTION INSTRUMENTATION BUT WAS UNSUCCESSFUL AS THE HELICAL BLADE WAS NOT ABLE TO BE REMOVED INDEPENDENTLY FROM THE NAIL. EVENTUALLY, HE EXTRACTED BOTH THE NAIL AND BLADE OUT TOGETHER. THE FOLLOWING ARE THE DEVICES USED IN THE CASE BUT ARE UNABLE TO DISASSEMBLE THEM

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9099841 ↗
• InjuryOct 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION SURGERY OF PROXIMAL FEMUR DUE TO FEMUR FRACTURE. THE PLAN WAS TO IMPLANT A TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA). WHEN IT CAME TIME TO IMPLANT THE NAIL, THE NURSE LEFT THE ROOM TO GET A TROCHANTERIC FIXATION AND A NAIL. UPON HER RETURN SHE HAD A TFN INSTEAD OF A TFNA AND THE NAIL WAS IMPLANTED. A NEW TYPE OF HELICAL BLADE WAS IMPLANTED ALONG WITH A TFN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY. THE PATIENT IS STABLE AND DOING FINE. THIS COMPLAINT INVOLVES TWO (2) DEVICE. THIS COMPLAINT IS FOR (1) 11MM/130 DEG TI CANN TROCH FIXATION NAIL. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7970602 ↗

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.