MAUDE Adverse Event Report: ORTHOPEDIATRICS 5.5/6.0 CANNULATED LENKE PROBE HOUSING

Model Number	01-1301-6021
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon was using cannulated probe for s2ai screw prep.When using, it broke in the patient past the si joint and they had to spend time to remove.This caused a delay greater than 30 mins.

• Brand Name: 5.5/6.0 CANNULATED LENKE PROBE HOUSING
• Common Device Name: 5.5/6.0 CANNULATED LENKE PROBE HOUSING
• 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: 23444409
• Report Number: 3006460162-2025-00063
• Device Sequence Number: 9067045
• Product Code: HXB
• UDI-Device Identifier: 00840194417044
• UDI-Public: 00840194417044
• 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): 10/31/2025

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: 01-1301-6021
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2025
• 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
• Patient Sex: Male