MAUDE Adverse Event Report: ORTHOPEDIATRICS 4.5MM/6.0MM CLAMPING HOOK, CLAMP ASSEMBLY

Model Number	00-1600-5000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon stripped a rib hook clamp screw and it broke in half inside the rib hook.Surgeon had to take construct apart when done to replace the rib hook and clamp.This caused a delay greater than 30 mins.

• Brand Name: 4.5MM/6.0MM CLAMPING HOOK, CLAMP ASSEMBLY
• Common Device Name: 4.5MM/6.0MM CLAMPING HOOK, CLAMP ASSEMBLY
• 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: 23490783
• Report Number: 3006460162-2025-00066
• Device Sequence Number: 8671994
• Product Code: MDI
• UDI-Device Identifier: 00840194422024
• UDI-Public: 00840194422024
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 11/06/2025

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: 00-1600-5000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown