MAUDE Adverse Event Report: ARTHREX, INC. 3.5X20MM BEVELED FT SCREW; BONE FIXATION SCREW/PLATE

Model Number	3.5X20MM BEVELED FT SCREW
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Implant Pain (4561)
Date of Event	10/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/18/2024, it was reported by a facility representative that a patient who was part of the clinical research study returned for a month's visit, in which it was found that the fracture had subsided, and the ar-8735bv-20 beveled ft screw was protruding into the mcp joint space.It was determined that removing the screw was the next step.No further information was provided.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: b5, g3.
Event or Problem Description
Additional information received on 10/24/2024: per the patient's medical records, the original procedure occurred on (b)(6) 2024 for a right angulated fifth metacarpal neck fracture.An arthrex non-compressive headless screw, 38 mm by 3.5 mm, was implanted.The patient's post-operation medical records note that on (b)(6) 2024, the patient showed no sign of infection.The patient was instructed to removal brace of a clamshell handcuffed brace all the time unless the patient is working on range of motion.On (b)(6) 2024, it was noted in the post-operative notes that the screw was starting to protrude.However, the patient was improving with range of motion as well as pain.On (b)(6) 2024, during a postoperative visit, the patient reported discomfort from the im screw.However, in the office visit note from (b)(6) 2024, radiographs showed a healed small finger metacarpal fracture in good alignment with minor unchanged protrusion of the screw into the pm joint.Given that the patient is experiencing pain, the surgeon recommended removing the screw.No further information was provided.
Additional Manufacturer Narrative
Additional information: d6a, g3, h3, h6 the failed device was not received for evaluation.Based on the provided information, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional details from the field, arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported failure is a patient-specific event, specifically foreign body sensitivity.The complaint allegation was confirmed based on the customer's attached x-rays, which show the screw protruding.

• Brand Name: 3.5X20MM BEVELED FT SCREW
• 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: 20586774
• Report Number: 1220246-2024-08366
• Device Sequence Number: 15085136
• Product Code: HWC
• UDI-Device Identifier: 00888867360655
• UDI-Public: 00888867360655
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K210994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Study,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/13/2025

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: 3.5X20MM BEVELED FT SCREW
• Device Catalogue Number: AR-8735BV-20
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2024
• Supplement Date Received by Manufacturer: 10/24/2024; 06/12/2025
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 11/14/2024; 06/13/2025
• 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
• Patient Sex: Unknown