NA 456.358SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982227300), received between May 9, 2018 and Dec 31, 2020 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 31, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, WHEN IMPLANTING A 10MM/130DEGREE TI CANNULATED TROCHANTERIC FIXATION NAIL 380MM, THE INTERNAL LOCKING MECHANISM WAS ALREADY DAMAGED. THE LOCKING MECHANISM WAS ENGAGED AND BECAUSE OF THAT THE DRILL/HELICAL BLADE COULD NOT GO THOROUGH THE NAIL. THE INTERNAL LOCKING MECHANISM WAS RELEASED IN ORDER TO GET THE HELICAL BLADE. THE FLEXIBLE SCREWDRIVER HAD TO USE TO GET THE INTERNAL LOCKING MECHANISM TO THE RIGHT PLACE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: UNKNOWN HELICAL BLADE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 10MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/RIGHT-STER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11102318 ↗
• InjuryMay 9, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A TROCHANTERIC FIXATION NAIL IN 2009. IN 2013, THE PATIENT COMPLAINED OF THE NAIL STICKING HIS SKIN IN THE BACK OF HIS HIP WHICH CAUSED A HOLE IN THE SKIN. THE NAIL ALSO FELL APART. PATIENT DEVELOPED A STAPHYLOCOCCUS INFECTION AND UNDERWENT SURGERY TO REMOVE THE NAIL ON AN UNKNOWN DATE. THE INFECTION DETERIORATED THE BONE AND THE HIP WAS REFRACTURED IN THE SAME LOCATION. THE SURGEON REMOVED 5 INCHES OF BONE (THE JOINT OF THE HIP) AND ALSO REMOVED TISSUE. AS A RESULT, OF THE HIP JOINT BEING REMOVED, THE PATIENT COULD NOT BE REVISED TO ANOTHER IMPLANT. PATIENT WAS PLACED ON ANTIBIOTICS AND WAS ATTENDED BY A HOME NURSE EVERY WEEK. PATIENT COMPLAINED THAT HIS NERVOUS SYSTEM HAS BEEN AFFECTED. PRIOR TO THE SURGERY, PATIENT WAS ACTIVE AND WORKED ON CARS. PATIENT HAS BEEN BED RIDDEN, UNABLE TO WALK AND IN A WHEEL CHAIR SINCE 2013. PATIENT WAS 5¿4¿ AND IS NOW 5¿3¿ AND WEIGHED (B)(6). AND NOW WEIGHS (B)(6). THIS REPORT IS FOR ONE (1) 10MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/RIGHT-STER. THIS IS REPORT 1 OF 1 FOR (B)(4).

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

  MAUDE report 7500379 ↗

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.