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

Model Number	01-1400-0041
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The threaded portion of the 1.25mm threaded wire in the 4.0 cannulated screw set broke off into the patient's arm without any severe manipulation.

• Brand Name: 1.25MM X 150MM GUIDE WIRE, THREADED
• Common Device Name: 1.25MM X 150MM 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: 24874938
• Report Number: 3006460162-2026-00018
• Device Sequence Number: 9331868
• Product Code: HWC
• UDI-Device Identifier: 00841132168905
• UDI-Public: 00841132168905
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K190324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 04/14/2026

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: 01-1400-0041
• Device Lot Number: 924024010-C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 9 YR
• Patient Sex: Female