MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP ROUND TIP 2.0MM X 300MM TI; ROUND TIP PIN

Model Number 00-1001-0120

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 01/24/2022

Event Type  malfunction  

Event Description

Patient has wound break down and subsequent infection at the top of the nail on the ulna.

• Brand Name: ROUND TIP 2.0MM X 300MM TI
• Type of Device: ROUND TIP PIN
• 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: 13714908
• MDR Text Key: 289491994
• Report Number: 3006460162-2022-00003
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 00-1001-0120
• Device Catalogue Number: 00-1001-0120
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: No
• Patient Sequence Number: 1
• Patient Age: 8 YR
• Patient Sex: Female
• Patient Weight: 18 KG