NA 456.325SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982226990), received between Apr 24, 2018 and Nov 14, 2018 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2018Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A TROCHANTERIC FIXATION NAIL (TFN) SYSTEM PROCEDURE, THE SURGEON WAS UNABLE TO ADVANCE A HELICAL BLADE DUE TO A LOCKING MECHANISM INTERFERENCE. THE SURGEON USED A DRILL BIT TO PREPARE FOR THE HELICAL BLADE INSERTION WITHOUT DIFFICULTY AND WITHOUT EVIDENCE OF ABNORMAL CONTACT WITH THE NAIL. AFTER DRILLING, THE SURGEON WAS UNABLE TO ADVANCE THE HELICAL BLADE. THERE WAS SURGICAL DELAY WHILE THE SURGEON DETERMINED WHAT THE PROBLEM WAS, BUT THE EXACT DURATION OF THE DELAY IS NOT KNOWN. THE SURGEON WAS ABLE TO IDENTIFY THAT THE LOCKING MECHANISM WAS OBSTRUCTING THE PATH OF THE HELICAL BLADE. THE SURGEON CONFIRMED WITH THE SCRUB NURSE THAT THE LOCKING MECHANISM HAD NOT BEEN ADVANCED PRIOR TO THE PROCEDURE OR DURING THE ASSEMBLY OF THE NAIL AND THE TARGETING DEVICE. THE FLEXIBLE DRIVER WAS THEN INSERTED AND USED TO REVERSE THE LOCKING MECHANISM. THE HELICAL BLADE WAS THEN INSERTED WITHOUT ANY FURTHER ABNORMAL RESISTANCE AND THE LOCKING MECHANISM WAS THEN ENGAGED. THE PROCEDURE WAS THEN COMPLETED ACCORDING TO SPECIFICATION IN THE TECHNIQUE. NO ADVERSE PATIENT OUTCOMES WERE NOTED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8071646 ↗
• InjuryApr 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A TROCHANTERIC FEMORAL NAIL (TFN) IN 2016. THE PATIENT SUFFERED FROM VARIOUS ILLNESS AND IS ADVANCED IN AGE. DUE TO INFECTION, THE PATIENT UNDERWENT A REMOVAL SURGERY ON (B)(6) 2018. IT WAS REPORTED THAT THE TFN NAIL, HELICAL BLADE AND A 5.0 LOCKING SCREW WERE REMOVED AND NOTHING WAS REPLACED. IT WAS ALSO REPORTED THAT AT THE END OF THE PROCEDURE THERE WAS A COMPLETE IRRIGATION OF THE INFECTED AREA WHICH WAS THE ENTIRE LEFT LEG OF THE PATIENT. THERE WERE LABORATORY CULTURE TESTS TAKEN DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. THE PATIENT OUTCOME IS UNKNOWN. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR ONE (1) 10MM/130 DEG TI CANN TROCH FIXATION NAIL 235MM-STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7454232 ↗

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.