inforMED
MalfunctionKIJ

1.6MM X 200MM SS GUIDE WIRE, THREADED

Received Mar 2, 2026 · Event occurred Feb 13, 2026

Report 3006460162-2026-00008 · MDR key 24486256

Device

Generic name

1.6mm X 200mm Ss Guide Wire, Threaded

Manufacturer

Orthopediatrics

Model number

01-9473-4120

Product problems

  • Fracture

Patient

NA · Female

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

TWO THREADED 1.6MM SS GUIDE WIRES BROKE OFF AT THE THREAD BASE INSIDE PATIENT'S HUMERUS DURING IMPLANTATION OF A SINGLE CANNULATED SCREW FOR TREATMENT OF A HUMERAL EPICONDYLE FRACTURE. THE FIRST BREAKAGE WAS INEXPLICABLE, THE SECOND BREAKAGE OCCURRED WHEN A SECOND WIRE WAS PASSING NEARBY THE FIRST RETAINED WIRE FRAGMENT. EXCESSIVE MANIPULATION OF WIRE TRAJECTORY WAS NOT OBSERVED.