MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP T15 BAND DOT RETAINING DRIVER, SHORT

Catalog Number 01-9000-0015

Device Problem Mechanical Problem (1384)

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

Event Date 03/17/2024

Event Type  malfunction  

Event Description

Screws and drivers would not engage each other.

• Brand Name: T15 BAND DOT RETAINING DRIVER, SHORT
• Type of Device: T15 BAND DOT RETAINING DRIVER, SHORT
• 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: 19120158
• MDR Text Key: 340827372
• Report Number: 3006460162-2024-00015
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 00084019440567
• UDI-Public: 0084019440567
• 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: 04/16/2024

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: 01-9000-0015
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/16/2024
• 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): Other