NA 458.952SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982230980), received between Jun 27, 2018 and Mar 9, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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.

• InjuryMar 9, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE THE DEFECTIVE BROKEN SCREW. ONLY ONE-HALF OF THE 5.0 MM LOCKING SCREW WAS ABLE TO BE REMOVED. ON OR ABOUT (B)(6) 2018, THE PATIENT FELL AND FRACTURED HIS LEFT HIP. ON OR ABOUT (B)(6) 2018, THE PATIENT UNDERWENT HIP PINNING SURGERY ON HIS LEFT HIP AND WAS IMPLANTED WITH A SYNTHES TFN ADVANCED PROXIMAL FEMORAL NAILING SYSTEM DEVICE INTO THE LEFT HIP AND LEFT FEMUR CONSISTING OF SYNTHES TFN ADVANCED SYSTEM LONG NAIL 12MM DISTAL DIAMETER, TITANIUM HELICAL BLADE 100 MM, AND ONE (1) SYNTHES 5.0 MM (5X52 MM) TITANIUM LOCKING SCREW WITH HEXAGONAL DRIVE. IN (B)(6) 2019, PLAINTIFF BEGAN TO EXPERIENCE DISCOMFORT AND PAIN IN THE LEFT HIP, THIGH, AND ABOVE THE KNEE AREA. ON OR ABOUT (B)(6) 2019, THE PATIENT WAS ADVISED THAT THE IMPLANTED FEMORAL SCREW WAS BROKEN. CONCOMITANT DEVICE REPORTED: TFN ADVANCED SYSTEM LONG NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1); TITANIUM HELICAL BLADE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW 52MM- FOR IM NAILS-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Discomfort; Foreign Body In Patient; Pain

  MAUDE report 11446752 ↗
• InjuryJun 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT WAS IMPLANTED WITH THE TROCHANTERIC FEMORAL NAIL-ADVANCED (TFNA) WHICH INCLUDES ONE (1) 11MM/125 DEG TI CANN TFNA 380MM/RIGHT - STERILE, ONE (1) TFNA SCREW 95MM - STERILE AND ONE (1) 5.0MM TI LOCKING SCREW 52MM- FOR IM NAILS-STERILE. ON AN UNKNOWN DATE POST-OPERATIVE, THE FEMORAL NECK COLLAPSED CAUSING THE PATIENT DISCOMFORT. ON (B)(6) 2018, THE PATIENT UNDERWENT REVISION SURGERY DUE TO NON-UNION IN THE FRACTURE SITE. THE ENTIRE IMPLANT WAS REMOVED AND REPLACED WITH A TOTAL HIP ARTHROPLASTY. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW 52MM- FOR IM NAILS-STERILE. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7642255 ↗