NA 412.214Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982210982), received between Dec 15, 2017 and Jan 19, 2021 — classified as 3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 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 4 OF 5 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 11195462 ↗
• InjuryOct 4, 2018Break; Break

  IT WAS REPORTED THAT INITIALLY ON (B)(6) 2018 A PATIENT UNDERWENT, THE OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE LEFT FEMUR, WHEREIN THE SURGEON IMPLANTED A TITANIUM BROAD LOCKING COMPRESSION PLATE WITHOUT ANY REPORTED ISSUES. ON AN UNKNOWN POSTOPERATIVE DATE, THE PATIENT COMPLAINED OF A TWINGE FEELING IN HIS LEG. RADIOLOGY IMAGES WERE TAKEN AND REVEALED A BROKEN PLATE AT THE PREVIOUS FRACTURE SITE. PATIENT UNDERWENT THE REVISION SURGERY WITH ORIF TO TREAT THE FEMORAL SHAFT PERI PROSTHETIC FRACTURE AND TAKE DOWN MALUNION ON (B)(6) 2018. DURING REVISION SURGERY THE SURGEON EXPLANTED THE BROKEN TITANIUM BROAD LOCKING COMPRESSION PLATE AND REPLACED IT WITH A NEW PLATE, SCREWS, CABLE AND BONE GRAFT. ALL FRAGMENTS WERE REMOVED WITHOUT COMPLICATIONS. THERE WERE NO ISSUES DURING THE REVISION SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT WAS STABLE AFTER SURGERY. PRELIMINARY INVESTIGATION OF THE RETURNED DEVICES REVEALED ONE OF THE 5.0MM LOCKING SCREWS IS BROKEN. IT IS NOT KNOWN IF THE DEVICE WAS BROKEN PRIOR TO OR DURING THE REMOVAL PROCEDURE. THE 4.5MM TITANIUM THREADED CERCLAGE POSITIONING PIN (498.803, LOT H476436, QUANTITY 4), 5.0MM TITANIUM LOCKING SCREW 40MM (412.214

  Patient problems: Bone Fracture(s); Discomfort; Not Applicable

  MAUDE report 7934163 ↗
• 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 7121191 ↗