MAUDE Adverse Event Report: ORTHOPEDIATRICS 13.5MM MODULAR REAMER HEAD

Model Number	01-1500-135
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reamer tip broke off of the reamer shaft inside of the tibial canal.Unable to complete surgery, temporary ex fix put on, revision surgery the next day using a smith and nephew trigen nail.

• Brand Name: 13.5MM MODULAR REAMER HEAD
• Common Device Name: 13.5MM MODULAR REAMER HEAD
• 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: 24224034
• Report Number: 3006460162-2026-00001
• Device Sequence Number: 21178431
• Product Code: HTO
• UDI-Device Identifier: 00841132150108
• UDI-Public: 00841132150108
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 01/30/2026

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: 01-1500-135
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/01/2026
• Initial Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 15 YR
• Patient Sex: Male