MAUDE Adverse Event Report: ORTHOPEDIATRICS 1.6MM X 200MM SS GUIDE WIRE, THREADED

Model Number	01-9473-4120
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
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.

• Brand Name: 1.6MM X 200MM SS GUIDE WIRE, THREADED
• Common Device Name: 1.6MM X 200MM SS GUIDE WIRE, THREADED
• Manufacturer (Section D): ORTHOPEDIATRICS; 2850 frontier drive; warsaw IN 46582
• Manufacturer (Section G): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw IN
• Manufacturer Contact: james gunnels ; 2850 frontier drive; warsaw, IN
• MDR Report Key: 24486256
• Report Number: 3006460162-2026-00008
• Device Sequence Number: 20109825
• Product Code: KIJ
• UDI-Device Identifier: 00840194465434
• UDI-Public: 00840194465434
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 01-9473-4120
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female