MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO MTP PLT,CONTRD,LNG,L,TI; PLATE, FIXATION, BONE

Model Number	LO-PRO MTP PLT,CONTRD,LNG,L,TI
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
The patient had surgery on the joint of her left big toe on the (b)(6) 2020, which was removed and replaced with a metal plate and screw.The patient returned to work on the (b)(6) 2021 with clearance from the surgeon.On the (b)(6) 2021, around 2 pm after lunch, the patient was walking up the stairs back to the lab when she felt a pain in the ball of her left foot.When she reached the top of the stairs, it was hard to bear weight (this was day 79 after the operation).On the (b)(6) 2021, she went to work and at 9 am, she phoned the surgeon's room to let them know she was in pain.She was asked to go and get an x-ray that morning which she did, and then went back to work for the rest of the day.On the (b)(6) 2021, she went to work until 10.15 am and then to the surgeon's room for an urgent appointment.The surgeon looked at her toe, bent severely to the left and swollen.The surgeon mentioned to the patient that it didn't look good.The patient and the surgeon looked at the x-ray.It showed the plate had broken towards the top.The surgeon said it was an unusual spot to break.
Additional Manufacturer Narrative
The complaint is confirmed based on the customer-provided photos, which identify that the ar-8944cl-l contoured plate broke into two pieces proximal to the bend origin.The cause remains undetermined, as the device was not returned for physical evaluation.No change in harm was identified.

• Brand Name: LO-PRO MTP PLT,CONTRD,LNG,L,TI
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 14195466
• Report Number: 1220246-2022-04808
• Device Sequence Number: 4378072
• Product Code: HRS
• UDI-Device Identifier: 00888867052888
• UDI-Public: 00888867052888
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: LO-PRO MTP PLT,CONTRD,LNG,L,TI
• Device Catalogue Number: AR-8944CL-L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 05/03/2021
• Initial Report FDA Received Date: 04/25/2022
• Supplement Report FDA Received Date: 05/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown