MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP 4.5MM CANNULATED SCREW, CANCELLOUS THREAD, 24MM

Catalog Number	00-1015-8024
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Situation: six out of six screw heads were deformed during extraction.All screws, including the deformed screw heads, were removed using a hospital-owned carbide drill and other tools.Surgeon's comment: i consider that there may have been a structural or design problem with the product in question, which may have caused this event.Delays in surgery: there was a delay of approximately two hours.Patient's post-operative course: it was good and uneventful and the patient was discharged on the second post-operative day.

• Brand Name: 4.5MM CANNULATED SCREW, CANCELLOUS THREAD, 24MM
• Common Device Name: CANNULATED SCREW
• 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: 21969513
• Report Number: 3006460162-2025-00025
• Device Sequence Number: 12880616
• Product Code: HWC
• UDI-Device Identifier: 00841132144749
• UDI-Public: 00841132144749
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• 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): 05/06/2025

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 Catalogue Number: 00-1015-8024
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 05/06/2025
• 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: 14 YR
• Patient Sex: Male