MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP EXTRACTION ADAPTOR; EXTRACTOR

Model Number 01-1500-9018

Device Problem Difficult to Remove (1528)

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

Event Date 12/21/2021

Event Type  malfunction  

Event Description

They could not remove the nail in the surgery because this did not thread on the nail.They had to plan another surgery to remove the nail.In the end everything was correct, but this reference did not work correctly.Delay greater than 30 minutes.

• Brand Name: EXTRACTION ADAPTOR
• Type of Device: EXTRACTOR
• 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: 13714969
• MDR Text Key: 289451355
• Report Number: 3006460162-2022-00002
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 01-1500-9018
• Device Catalogue Number: 01-1500-9018
• 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: 13 YR
• Patient Sex: Male