NA 456.401SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982227690), received between Jun 28, 2019 and Jun 28, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 reports).

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.

• InjuryJun 28, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, PATIENT UNDERWENT TOTAL HIP SURGERY WHEREIN TROCHANTERIC FIXATION NAIL (TFN) AND TITANIUM HELICAL BLADE WAS EXPLANTED. OPERATIVE NOTES SAY THAT 125 DEGREE NAIL WAS PUT IN THE PATIENT BUT THE DOCTOR DID NOT HAVE A 125 DEGREE HELICAL BLADE AIMING ARM SO TRIED TO USE 130 DEGREE ARM. THE HELICAL BLADE WAS LEFT UPSIDE DOWN IN THE PATIENT AND NAIL. DUE TO THIS, THE NAIL COULD NOT BE LOCKED. SURGICAL DELAY WAS UNKNOWN. PATIENT OUTCOME STATUS IS UNKNOWN. CONCOMITANT DEVICE/S REPORTED: UNKNOWN LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY OF 1). THIS REPORT IS FOR ONE (1) 11MM/125 DEG TI CANN TROCH FIXATION NAIL 400MM/LEFT-STER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8744238 ↗
• InjuryJun 28, 2019Device-Device Incompatibility; Device-Device Incompatibility

  ON (B)(6) 2019: IT WAS REPORTED THAT THE DEVICE WAS PUT IN IMPROPERLY AND IT COULD NOT BE LOCKED BECAUSE THE HELICAL BLADE WAS UPSIDE DOWN.

  Patient problems: No Code Available

  MAUDE report 8743979 ↗

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.