MAUDE Adverse Event Report: ORTHOPEDIATRICS 2.0MM DRILL BIT

Model Number	01-1005-0003
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
This case was a non-union repair of an ulnar fx.Surgeon was using the drill bit to drill out the canal of the ulna after a flex nail was removed when the tip of the driver broke off in the canal.Further dissection was needed and the broken piece was retrieved after about a 30 minute delay.

• Brand Name: 2.0MM DRILL BIT
• Common Device Name: 2.0MM DRILL BIT
• Manufacturer (Section D): ORTHOPEDIATRICS; 2850 frontier drive; warsaw IN 46582
• Manufacturer (Section G): ORTHOOEDIATRICS, CORP; 2850 frontier drive; warsaw IN
• Manufacturer Contact: james gunnels ; 2850 frontier drive; warsaw, IN
• MDR Report Key: 23436423
• Report Number: 3006460162-2025-00061
• Device Sequence Number: 14642162
• Product Code: GFG
• UDI-Device Identifier: 00841132122570
• UDI-Public: 00841132122570
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 10/30/2025

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: 01-1005-0003
• Device Lot Number: 923017730-D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 10/31/2025
• 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