MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP CHILD NAIL CONICAL EXTRACTION ADAPTOR

Model Number	01-1501-0128
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Bolt tip broke off in nail while trying to extract nail causing a delay greater than 30 mins.

• Brand Name: CHILD NAIL CONICAL EXTRACTION ADAPTOR
• Common Device Name: EXTRACTION ADAPTOR
• Manufacturer (Section D): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw IN 46582
• Manufacturer (Section G): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw IN 46582
• Manufacturer Contact: james gunnels ; 2850 frontier drive; warsaw, IN 46582
• MDR Report Key: 15921661
• Report Number: 3006460162-2022-00041
• Device Sequence Number: 16777278
• Product Code: HWB
• UDI-Device Identifier: 00841132177624
• UDI-Public: 00841132177624
• 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): 12/05/2022

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: 01-1501-0128
• Device Catalogue Number: 01-1501-0128
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male