MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP 10MM X 360MM ADOLESCENT NAIL, LEFT

Catalog Number 00-1503-1036

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2024

Event Type  malfunction  

Event Description

The lateral-medial static screw hole would not fit a 5.0 fully threaded screw.Screws were swapped with a screw of the same corresponding length m without any success.And not only was inserting these screws difficult, removing them took a vice grip and a ton of force.Caused a delay of greather than 30 mins.

• Brand Name: 10MM X 360MM ADOLESCENT NAIL, LEFT
• Type of Device: 10MM X 360MM ADOLESCENT NAIL, LEFT
• 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: 18915532
• MDR Text Key: 337801821
• Report Number: 3006460162-2024-00012
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00084113214689
• UDI-Public: 0084113214689
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NANA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 00-1503-1036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 14 YR
• Patient Sex: Female
• Patient Weight: 101 KG