NA 412.217Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982211019), received between Dec 15, 2017 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. How this data works · Data updated Oct 13, 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 JUNE 11, 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 46MM. THIS IS REPORT 5 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Fall; Limb Fracture

  MAUDE report 17250635 ↗
• InjuryDec 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION OF A TITANIUM DISTAL FEMUR LESS INVASIVE STABILIZATION SYSTEM (LISS) PLATE AND THIRTEEN (13) SCREWS TO AN UNKNOWN ZIMMER PLATE CONSTRUCT DUE TO A FRACTURE WHICH WAS SLIGHTLY DISTAL TO THE SYNTHES LISS FEMUR PLATE ON (B)(6) 2017. ONE (1) LISS PLATE ALONG WITH APPROXIMATELY THIRTEEN (13) UNKNOWN SCREWS WERE INITIALLY IMPLANTED ON AN UNKNOWN DATE A FEW YEARS AGO. BASED ON A PREVIOUSLY TAKEN X-RAY (UNAVAILABLE) TAKEN BEFORE THE REVISION SURGERY, THE PLATE AND SCREWS ALL SEEMED INTACT AND WERE FOUND INTACT DURING SURGERY. THE REVISION PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNKNOWN DELAY IN SURGERY DUE TO THREE (3) SYNTHES SCREWDRIVERS BREAKING WHILE REMOVING THE THREE (3) COLD WELDED / CROSS THREADED SCREWS THAT WERE STUCK TO THE PLATE. AFTER THE SCREWDRIVERS BROKE, THE SCREWS HAD TO BE CUT OUT WITH A BIG BURR. IT IS UNKNOWN IF THERE WERE ANY FRAGMENTS LEFT INSIDE THE PATIENT. THIS REPORT ADDRESSES THE POSTOPERATIVE REVISION DUE TO PATIENT¿S FRACTURE WHICH WAS SLIGHTLY DISTAL TO THE SYNTHES LISS FEMUR PLATE THE INTRAOPERATIVE ISSUE OF COLD WELDED / CROSS THREADED SCREWS THAT WERE STUCK TO THE PLATE. THE INTRAOPERATIVE ISSUE OF TH

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 7121330 ↗