MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,4.0 STD,40MM LGTH; BONE FIXATION SCREW/PLATE

Model Number	COMPR FT SCRW,4.0 STD,40MM LGTH
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	05/31/2021
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 3/20/2024, an inquiry was submitted by a nurse case manager via phone for a patch test kit on behalf of a patient and surgeon.The patient is experiencing severe itching on both ankles and femur where the ar-8740-40h standard compression ft, titanium, 4 mm x 40 mm, ar-8740-48h standard compression ft, titanium, 4 mm x 48 mm, and ar-8740-50h standard compression ft, titanium, 4 mm x 50 mm was implanted.They would like to know if these screws are the cause of the sensitivity the patient is experiencing.If proven, there will be an additional surgery to remove the screws.Additional information was received on 3/22/2024: material composition was requested by the nurse case manager on ar-8740-40h standard compression ft, titanium, 4 mm x 40 mm, ar-8740-48h standard compression ft, titanium, 4 mm x 48 mm, and ar-8740-50h standard compression ft, titanium, 4 mm x 50 mm that was implanted in the patient during a orif of left and right talus as well as arthroscopy with foreign body removal of left and right ankle on (b)(6) 2021.Screws were used bilaterally.The symptoms of severe itching and skin irritation have been occurring since shortly after this time and the patient has been treated topically with triamcinolone for the past 2+ years.
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: COMPR FT SCRW,4.0 STD,40MM LGTH
• Common Device Name: BONE FIXATION SCREW/PLATE
• 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: jared engle ; 8009337001
• MDR Report Key: 19107045
• Report Number: 1220246-2024-02020
• Device Sequence Number: 7766442
• Product Code: HRS
• UDI-Device Identifier: 00888867127784
• UDI-Public: 00888867127784
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K201132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2025

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
• Operator of Device: Health Professional
• Device Model Number: COMPR FT SCRW,4.0 STD,40MM LGTH
• Device Catalogue Number: AR-8740-40H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown