MAUDE Adverse Event Report: Arthrex, Inc. COMPR FT SCRW, 5.0 LG, 34MM LGTH; BONE FIXATION PLATE

Model Number	COMPR FT SCRW, 5.0 LG, 34MM LGTH
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	09/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On 09-sep-2026, it was reported by a sales representative via phone that an ar-8750-34h compression screw is causing irritation to the skin at the incision site.The device was implanted into the patient on (b)(6) 2026.The patient has been complaining about this issue after implantation.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: COMPR FT SCRW, 5.0 LG, 34MM LGTH
• Common Device Name: BONE FIXATION PLATE
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50881867
• Report Number: 1220246-2026-04875
• Device Sequence Number: 10704735
• Product Code: HRS
• UDI-Device Identifier: 00888867262898
• UDI-Public: 00888867262898
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K201132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: COMPR FT SCRW, 5.0 LG, 34MM LGTH
• Device Catalogue Number: AR-8750-34H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/24/2026
• 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