NA 412.218Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982211026), received between Jan 19, 2021 and Jan 19, 2021 — classified as 1 injury.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, A HARDWARE REMOVAL AND OPEN REDUCTION INTERNAL FIXATION (ORIF) WITH AN INTRAMEDULLARY NAIL WAS PERFORMED DUE TO SUB-TROCHANTERIC FEMUR FRACTURE. THE PATIENT ORIGINALLY UNDERWENT SURGERY FOR DISPLACED FEMORAL NECK FRACTURE ON (B)(6) 2020. AT THAT TIME, THE PATIENT WAS TREATED WITH A FEMORAL NECK SYSTEM. PATIENT SUBSEQUENTLY SLIPPED AND FELL AT HOME ON (B)(6) 2020 AND SUSTAINED A COMMINUTED SUB-TROCHANTERIC FEMUR FRACTURE. THE FNS HARDWARE WAS REMOVED AND THE PATIENT WAS IMPLANTED WITH FEMORAL RECON NAIL. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCR SLF-TPNG WITH T25 STARDRIVE RECESS 40MM. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 11195685 ↗