MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP OFFSET HOOK; 4.5/5.0 OPEN RIGHT 40 DEG OFFSET HOOK, 5MM

Catalog Number	00-1600-3305
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Rods had been placed and final tightening was being performed with the 12nm torque limiter.When the set screw of the hook was tightened an audible pop was heard.After examination it was determined the top 2 threads on the medial side of the hook had sheered off.The rod had to be removed.The hook was replaced with a 00-1600-3315.The new hook was tightened with a 7nm torque limiter and the set screw was flush with the 5.0 cocr rod.

• Brand Name: OFFSET HOOK
• Common Device Name: 4.5/5.0 OPEN RIGHT 40 DEG OFFSET HOOK, 5MM
• Manufacturer (Section D): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw IN
• Manufacturer (Section G): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw IN
• Manufacturer Contact: james gunnels ; 2850 frontier drive; warsaw, IN
• MDR Report Key: 21621900
• Report Number: 3006460162-2025-00020
• Device Sequence Number: 18271782
• Product Code: NKB
• UDI-Device Identifier: 00841132153154
• UDI-Public: 00841132153154
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/17/2025

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?: No
• Device Catalogue Number: 00-1600-3305
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 10 YR
• Patient Sex: Male