MalfunctionHSB

REDEMPTION DUO HINDFOOT NAIL SYSTEM

Received Oct 24, 2024 · Event occurred Oct 10, 2024

Report 20522062 · MDR key 20522062

Device

Generic name

Rod, Fixation, Intramedullary And Accessories

Manufacturer

Vilex Llc

Model number

RD-INST-T

Patient

46 YR · Female

Insufficient Information
Insufficient Information

Narrative

Description of Event or Problem

VILEX IMPLANTABLE TRAY: THE INSERTION TOOL BROKE OFF THE IMPACTOR PLATE WHEN THE SHALLOT MALLET WAS USED TO DRIVE THE IMPLANTABLE NAIL. THIS ALSO CAUSED THE INSERTION TOOL LOCKING MECHANISM ON THE ROD PIECE TO BECOME JAMMED AND UNABLE TO UNSCREW.