NA 412.215Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982210999), received between Apr 15, 2020 and Jul 3, 2023 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2023, THE SURGEON TOOK OUT THE PLATE, BOLT, ANTI ROTATIONAL AND LOCKING SCREWS AND REVISED IT WITH A LONG FEMUR IM NAIL, (SMITH AND NEPHEW INERTAN ). THE ACTUAL FNS PLATE, BOLT AND SCREWS OR THE COMPLETE IMPLANT CONSTRUCT WAS NOT DAMAGED AT TIME OF EXTRACTION; WHEN THE EXTRACTION TOOK PLACE, IT WAS SEEMED THE PATIENT FELL AND FRACTURED HER FEMUR BELOW THE PLATE OR BELOW THE MOST DISTAL SCREWS IN THE PLATE. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCR SLF-TPNG WITH T25 STARDRIVE RECESS 42MM. THIS IS REPORT 4 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Fall; Limb Fracture

  MAUDE report 17249657 ↗
• InjuryApr 15, 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 PATIENT UNDERWENT A REVISION OF FEMORAL NECK SYSTEM (FNS) IMPLANTS TO HEMIARTHROPLASTY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: BOLT FOR FEMORAL NECK SYSTEM 80MM LENGTH-STERILE (PART NUMBER 04.168.280S, LOT UNKNOWN, QUANTITY 1), FEMORAL NECK SYSTEM PLATE 1 HOLE ¿ STERILE (PART NUMBER 04.168.000S, LOT UNKNOWN, QUANTITY 1), ANTI-ROTATION SCREW FOR FEMORAL NECK SYS 85MM LENGTH ¿ STERILE (PART NUMBER 04.168.485S, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 5.0MM TI LOCKING SCR SLF-TPNG WITH T25 STARDRIVE RECESS 42MM. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Injury; No Code Available

  MAUDE report 9961952 ↗