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

Model Number 01-1501-0128

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

The extractor was threaded into the child size pnp nail.Final screw was removed and the extraction handle was mounted to the extractor.The backslap was used to start to remove the nail.The mail came out about 3cm before it stopped.After multiple blows the tip of the extractor broke off in the nail.A specialized nail removal set was then used as the tip of the extractor was in the nail preventing a second extractor from being threaded in.It took about an additional 1 hour to remove.

• Brand Name: CHILD NAIL CONICAL EXTRACTION ADAPTOR
• Type of Device: 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: 15555090
• MDR Text Key: 302026444
• Report Number: 3006460162-2022-00032
• Device Sequence Number: 1
• Product Code: HWB
• 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

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 01-1501-0128
• Device Catalogue Number: 01-1501-0128
• Device Lot Number: 1776101-A
• Patient Sequence Number: 1
• Patient Sex: Female