NA 456.476SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982228369), received between Dec 19, 2017 and Jun 21, 2018 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 21, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HIP SURGERY ON (B)(6) 2018. DURING THE PROCEDURE, THE HELICAL BLADE DID NOT PASS THROUGH THE TROCHANTERIC FIXATION NAIL SYSTEM (TFN) ON BACK TABLE WHEN TESTING THE NAIL PRIOR TO INSERTION INTO PATIENT. THIS RESULTED IN THE USE OF THE TFN-ADVANCED PROXIMAL FEMORAL NAILING SYSTEM (TFNA) INTRAOPERATIVELY. POSTOPERATIVELY, THE SURGERY TEAM CAME TO REALIZE THAT OUT OF THE STERILE PACKAGING, THE SET SCREW WAS ENGAGED TOO FAR INTO THE NAIL, ENGAGING THE LOCKING MECHANISM IN THE NAIL AND PREVENTING THE HELICAL BLADE FROM PASSING. THE SET SCREW NEEDED TO BE DIALED BACK A FEW TURNS IN ORDER THE FOR THE BLADE TO PASS. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES: TFN HELICAL BLADE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), TRAUMA SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A 12MM/130 DEG TITANIUM (TI) CANN TROCH FIXATION NAIL 360MM/RIGHT-STER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7626773 ↗
• InjuryApr 4, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT A PATIENT HAD A REMOVAL AND REVISION SURGERY ON (B)(6) 2018. THE PATIENT WAS INITIALLY IMPLANTED WITH (1)12MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/RIGHT, ONE (1) 11.0MM TI HELICAL BLADE AND ONE (1) DISTAL LOCKING SCREW ON AN UNKNOWN DATE. THE SURGEON REMOVED THE NAIL ON (B)(6) 2018 DUE TO THE NAIL COLLAPSING AND THE PATIENT WAS REVISED TO A CEMENT BIPOLAR NAIL IMPLANT. THE REMOVAL PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE PATIENT HAD A LESS THAN DESIRABLE TREATMENT OUTCOME DUE TO THE NAIL COLLAPSING, BUT WAS REPORTED TO BE FINE AT THE END OF THE PROCEDURE. CONCOMITANT DEVICE (S) REPORTED: 11.0MM TI HELICAL BLADE 95 MM (PART # 456.304, LOT # H0283791), UNKNOWN DISTAL LOCKING SCREW (UNKNOWN PART AND LOT NUMBER, QTY # 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7396704 ↗
• InjuryDec 19, 2017Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2017 DUE TO BROKEN TROCHANTERIC FIXATION NAIL (TFN). THE NAIL WAS INITIALLY IMPLANTED IN (B)(6) 2017. THE BROKEN NAIL WAS REMOVED ALONG WITH A LAG SCREW 95 MM AND LOCKING SCREW 36 MM. THE PATIENT WAS IMPLANTED WITH A NEW TFN NAIL 12/360, LAG SCREW 95 MM AND LOCKING SCREW 36 MM. THE SURGERY WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: LAG SCREW 95 MM (PART # 04.032.095 LOT # H302966 QTY # 1), 36 MM LOCKING SCREW (PART # 458.936, LOT # H257568, QUANTITY 1). THIS REPORT IS FOR ONE (1) 12 MM/130 DEG TI CANN TROCH FIXATION NAIL 360 MM/RIGHT-STER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 7128215 ↗

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.