NA 456.315SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982226907), received between Feb 21, 2018 and Jun 24, 2021 — classified as 4 injuries, 3 malfunctions.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN ORTHOPEDIC PROCEDURE, AFTER THE TFNA IMPLANTED ON (B)(6) 2021, THE FEMUR WAS BROKEN BELOW DISTAL INTERLOCKING SCREW IN NAIL. NAIL, LAG SCREW, AND DISTAL INTERLOCKING SCREW WERE REMOVED ON (B)(6) 2021 AND SWAPPED OUT WITH NEW TFNA EXCHANGE NAIL, LAG SCREW AND NEW INTERLOCKING SCREW DISTALLY. THE PROCEDURE SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) 10/130 DG TI CAN TROCH FIXATN NL 170-S THIS REPORT IS 1 OF 3 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 12060553 ↗
• MalfunctionMar 19, 2021Break; Break

  IT WAS REPORTED THAT DURING A REVISION PROCEDURE ON (B)(6) 2021, A SHORT TITANIUM TROCHANTERIC FIXATION NAIL (TFN) WAS REMOVED DUE TO A FRACTURE DISTAL TO END OF THE NAIL. THE TFN NAIL BROKE AT THE DISTAL SCREW HOLES WHEN IT WAS BEING EXTRACTED. THE BROKEN FRAGMENT WAS THEN PUSHED OUT OF THE FRACTURE SITE. THE SHORT TFN NAIL WAS THEN REPLACED WITH A LONG TFN NAIL. THERE WAS A SURGICAL DELAY OF 30 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT CAPTURES THE INTRA-OP EVENT OF TFN NAIL BREAKAGE WHILE RELATED COMPLAINT (B)(4) CAPTURES THE POST-OP OF EVENT OF SHORT TFN REMOVAL DUE TO A FRACTURE DISTAL TO THE END OF THE NAIL. THIS REPORT IS FOR 1 10MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11531977 ↗
• InjuryJun 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON REMOVED TROCHANTERIC FIXATION IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON REMOVED ALL THREE TROCHANTERIC FIXATION NAIL (TFN) TO THE PATIENT NOT HEALING AND NEEDING TO CONVERT TO A TOTAL HIP. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: 11.0MM TI HELICAL BLADE 95MM (PART NUMBER 456.304, LOT 3L39728, QUANTITY (B)(4)),5.0MM TI LOCKING SCREW 38MM- FOR IM NAILS (PART NUMBER 458.938, LOT H856858, QUANTITY (B)(4)). THIS REPORT INVOLVES ONE (1) 10MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10194854 ↗
• MalfunctionNov 18, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019 WHILE USING A TROCHANTERIC FIXATION NAIL (TFN) NAIL THE SURGEON MISSED THE NAIL WHEN DRILLING AND IT RESULTED IN THE SCREW MISSING THE NAIL. THE SURGEON TRIED TO REDO IT BUT DECIDED TO LEAVE IT OUTSIDE THE NAIL. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR ONE (1) 10MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE. THIS IS REPORT 7 OF 7 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9336962 ↗
• InjuryOct 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, A PATIENT UNDERWENT A REMOVAL OF TITANIUM TROCHANTERIC FIXATION NAIL (TFN) DUE TO A NON-UNION OF INTERTROCHANTERIC HIP FRACTURE. THE HARDWARE WAS ORIGINALLY IMPLANTED ON (B)(6) 2018. THE IMPLANT WAS REVISED TO A TOTAL HIP PROSTHESIS. IT IS UNKNOWN IF THE SURGERY WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 10MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Bone Fracture(s); Failure of Implant

  MAUDE report 7985916 ↗
• InjuryOct 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT REMOVAL OF A TROCHANTERIC FIXATION NAIL (TFN) DUE TO A FRACTURE BELOW THE SHORT NAIL. THE SURGEON REMOVED THE NAIL AND REPLACED IT WITH A LONG PROXIMAL FEMORAL NAILING SYSTEM (TFNA). ORIGINAL SURGERY WAS DONE ON (B)(6) 2018. THE SURGEON MISSED WITH THE DISTAL LOCKING SCREW FOR THE NAIL IN THE ORIGINAL SURGERY. THERE WAS NO SURGICAL DELAY. PATIENT OUTCOME WAS STABLE. THIS COMPLAINT CAPTURES THE POST-OPERATIVE FRACTURE. THE SURGEON MISSING WITH THE DISTAL LOCKING SCREW IN THE ORIGINAL PROCEDURE IS BEING CAPTURED UNDER RELATED COMPLAINT (B)(4). THIS REPORT IS FOR A TFN NAIL. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 7926996 ↗
• MalfunctionFeb 21, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT IN PREPARATION FOR A SHORT TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) IN THE PROXIMAL FEMUR PROCEDURE ON (B)(6) 2018 THE INTERNAL LOCKING PIECE WITHIN A STERILE TI CANNULATED TROCHANTERIC FIXATION NAIL FELL OUT. THE SCRUB TECH WAS GETTING THE DEVICE READY FOR THE PROCEDURE, WHEN HE PULLED THE PLASTIC PIECE OUT OF THE DEVICE (PER PROCEDURE) AND THE INTERNAL LOCKING PIECE CAME OUT ALONG WITH IT. THE DEVICE WAS TAKEN OFF OF THE FIELD AND ANOTHER DEVICE WAS USED IN THE PROCEDURE. THE REPORTED DEVICE WAS NEVER USED IN SURGERY OR IN A PATIENT. THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT REPORTED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7285733 ↗

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.