MAUDE Adverse Event Report: NEXTREMITY SOLUTIONS, INC. AXI+LINE; PLATE

Device Problem Unintended Movement (3026)

Patient Problem Insufficient Information (4580)

Event Date 10/18/2021

Event Type  malfunction  

Event Description

2nd axi+line case by dr.(b)(6).Procedure was thought to be a great case.Dr.(b)(6) was pleased with hardware at the time of suturing up the patient.This is his second axi+line case and lots of movement post op.Patient claims wb minimally in cam boot the whole time.Alignment ok, but hardware will likely come out.

Manufacturer Narrative

The complaint device information was not reported by the surgeon or the representative who reported the complaint to nextremity solutions, inc.The device remains implanted, but the patient is due to have the current plate removed, and replaced.The representative who reported the complaint will return the complaint device to nextremity once the revision has taken place, and product review can be completed.The information provided was specific to the axi+line instrument kit, which does not contain the actual complaint device so no dhr investigation could take place due to lack of accurate part and lot information for the complaint device.The plate is not sold inside of the kit, so traceability to components in the kit could not be performed for this complaint.A follow-up report will be provided when the complaint device is received and a full investigation can take place.

• Brand Name: AXI+LINE
• Type of Device: PLATE
• Manufacturer (Section D): NEXTREMITY SOLUTIONS, INC.; 1195 polk drive; warsaw IN 46582
• Manufacturer (Section G): NEXTREMITY SOLUTIONS, INC.; 1195 polk drive; warsaw IN 46582
• Manufacturer Contact: travis christman ; 1195 polk drive; warsaw, IN 46582
• MDR Report Key: 12915285
• MDR Text Key: 286134895
• Report Number: 3009540749-2021-00040
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention