MAUDE Adverse Event Report: ORTHOPEDIATRICS ADOLESCENT NAIL CONICAL EXTRACTION ADAPTOR

Model Number	01-1503-0128
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The extraction adaptors broke intraoperatively during the removal of the pnp nail in the child and adolescent system.The adaptors broke inside the nails.This issue caused difficulties and a delay.

• Brand Name: ADOLESCENT NAIL CONICAL EXTRACTION ADAPTOR
• Common Device Name: ADOLESCENT NAIL CONICAL EXTRACTION ADAPTOR
• 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: 23607395
• Report Number: 3006460162-2025-00074
• Device Sequence Number: 13062461
• Product Code: HWB
• UDI-Device Identifier: 00841132177631
• UDI-Public: 00841132177631
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 11/20/2025

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: 01-1503-0128
• Device Lot Number: 2057901-A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown