MAUDE Adverse Event Report: ORTHOPEDIATRICS T15 HEXALOBE DRIVER

Model Number	01-0903-0003
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The 3.5 wide medial plate was used to reduce & fix a distal tibial fracture.When the t15 driver was used to hand tighten the middle distal (3.5) screw, the tip of the driver sheared off.The tip of the driver shaft was embedded into the screw head and couldn't be removed by suction or with dental curette on examination.Therefore the tip of the driver shaft was left in-situ.

• Brand Name: T15 HEXALOBE DRIVER
• Common Device Name: T15 HEXALOBE DRIVER
• 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: 24292457
• Report Number: 3006460162-2026-00002
• Device Sequence Number: 10247695
• Product Code: LXH
• UDI-Device Identifier: 00841132122266
• UDI-Public: 00841132122266
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 02/09/2026

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: 01-0903-0003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 13 YR
• Patient Sex: Male
• Patient Weight: 64 KG