MAUDE Adverse Event Report: ORTHOPEDIATRICS 1.25MM X 150MM SS GUIDE WIRE, THREADED

Model Number	01-9473-3115
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Threaded tip guide wire broke off in patient's humerus.Dr.(b)(6) states she was not manipulating wire trajectory and was not passing wire through/against cortical bone.This was the first pass with the wire.

• Brand Name: 1.25MM X 150MM SS GUIDE WIRE, THREADED
• Common Device Name: 1.25MM X 150MM 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: 25015764
• Report Number: 3006460162-2026-00023
• Device Sequence Number: 21406303
• Product Code: KIJ
• UDI-Device Identifier: 00840194465359
• UDI-Public: 00840194465359
• 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): 04/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 01-9473-3115
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown