MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW,TI,3.5MMX 24MM; BONE FIXATION SCREW/PLATE

Model Number	LO-PRO SCRW,TI,3.5MMX 24MM
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Malunion of Bone (4529)
Date of Event	10/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2025, it was reported by a sales representative via phone that a patient underwent a proximal humerus fracture procedure on (b)(6) 2023.A 3024-011 left alpha plate, an ar-8935-24 low profile screw, titanium, non-locking, an 8110-026 cortical bone screw, an 8110-024 cortical bone screw, two 8110-028 cortical bone screw, two 8124-036 cancellous locking screw, two 8124-044 cancellous locking screw, an 8124-032 cancellous locking screw, an 8124-048 cancellous locking screw, an 8124-046 cancellous locking screw, three 8114-026 double lead lock cortical screw, an 8124-042 cancellous locking screw, an 8124-038 cancellous locking screw, and an 8124-030 cancellous locking screw were implanted.Due to nonunion, the patient underwent a second surgery on (b)(6) 2024 to have an ar-18827p-16 20 hole reinforced straight plate, an ar-18827-30 cortical screw, ar-18827-18 cortical screw, ar-18827v-18, an ar-18827v-16 val screw, an ar-18827v-22 val screw, two ar-18827v-20 val screw an ar-18827v-10 val screw, and an abs-2010-10 allosync pure implanted.All the previously implanted products during the initial surgery on (b)(6) 2023 remained in the patient.
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 is a patient-specific event.

• Brand Name: LO-PRO SCRW,TI,3.5MMX 24MM
• 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: 21536458
• Report Number: 1220246-2025-00802
• Device Sequence Number: 7857574
• Product Code: HWC
• UDI-Device Identifier: 00888867050501
• UDI-Public: (01)00888867050501(11)220908(10)14999900
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K203294
• 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,Followup
• Report Date (Section B): 09/05/2025

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: LO-PRO SCRW,TI,3.5MMX 24MM
• Device Catalogue Number: AR-8935-24
• Device Lot Number: 14999900
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2022
• 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