MAUDE Adverse Event Report: ARTHREX, INC. PROXIMAL HUMERAL PLATE, 8 HOLE; FIXATN NAIL/BLADE/PLATE COMBO

Model Number	PROXIMAL HUMERAL PLATE, 8 HOLE
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994)
Date of Event	10/03/2023
Type of Reportable Event	Serious Injury
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
On (b)(6) 2024, it was reported by a patient who underwent a procedure where arthrex devices were implanted was experiencing a painful reaction.The initial procedure occurred on (b)(6) 2023.T he patient began to experience pain 3-4 weeks post.The patient was referred to a pain specialist who suggested she was having an allergic reaction as the scar was red and puffy.She noted she feels terrible pain and throbbing, and when attempting to lift, it's painful.The surgeon mentioned she could have the devices removed in 6 months from her surgery date.However, she is not sure she can take the pain that much longer.No additional information was provided, and additional information has been asked.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to a patient-specific event.

• Brand Name: PROXIMAL HUMERAL PLATE, 8 HOLE
• Common Device Name: FIXATN NAIL/BLADE/PLATE COMBO
• 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: emily shafer ; 8009337001
• MDR Report Key: 18634023
• Report Number: 1220246-2024-00719
• Device Sequence Number: 15444867
• Product Code: KTW
• UDI-Device Identifier: 00848665006360
• UDI-Public: 00848665006360
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K080590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2025

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: PROXIMAL HUMERAL PLATE, 8 HOLE
• Device Catalogue Number: 3012-008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2024
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 02/02/2024
• Supplement Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Sex: Female