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
OrthopediatricsModel number
01-9473-4120Product 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.