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	Insufficient Information (4580)
Date of Event	12/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021, implants were placed in a total of four locations on the distal medial and lateral sides of the right femur and on the proximal medial side of the right and left tibia as growth control surgery at the medical institution.The implants were subsequently removed on (b)(6) 2024, some three years later.At that time, the following defects occurred.A total of eight screws were attempted to be removed using a hexagonal screwdriver.Of the eight screws, six screws could not be removed because their heads were deformed or broken during the removal operation.Therefore, a carbide drill was used to destroy the heads of the six screws that were deformed or broken.

• Brand Name: 4.5MM CANNULATED SCREW, CANCELLOUS THREAD, 24MM
• Common Device Name: 4.5MM CANNULATED SCREW, CANCELLOUS THREAD, 24MM
• 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: 21238201
• Report Number: 3006460162-2025-00004
• Device Sequence Number: 8439905
• 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: 2021
• Device Explanted Year: 2024
• 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): 01/26/2025

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: 12/27/2024
• Initial Report FDA Received Date: 01/26/2025
• 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: Other
• Patient Age: 14 YR
• Patient Sex: Male