MAUDE Adverse Event Report: ARTHREX, INC. VAL SCREW, TI, 2.0 X 14MM; BONE FIXATION SCREW/PLATE

Model Number	VAL SCREW, TI, 2.0 X 14MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	02/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 2/24/2025, it was reported by a sales representative via email that two 2.0 mm screw heads snapped off.The first screw head broke off during insertion and the second one broke when it was being removed, in exchange for a shorter screw.The fragments were removed.This was discovered during a metacarpal fracture procedure on (b)(6) 2025.
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, d1, d4, h3, h6.
Event or Problem Description
Additional information received on 3/6/2025: the part number for the screws are ar-18720v-14 val screw and ar-18720-12 cortical screw.The body of both screws remains in the patient.The case was completed using an ar-18720v-14 val screw and an ar-18720-12 cortical screw.The case was delayed for about five minutes without additional anesthesia.
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 can be attributed misuse due to misaligned insertion; or prying/leveraging the screw during insertion.

• Brand Name: VAL SCREW, TI, 2.0 X 14MM
• 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: 21582956
• Report Number: 1220246-2025-00885
• Device Sequence Number: 9275651
• Product Code: HRS
• UDI-Device Identifier: 00888867311718
• UDI-Public: 00888867311718
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 09/10/2025

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: VAL SCREW, TI, 2.0 X 14MM
• Device Catalogue Number: AR-18720V-14
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: Not provided; 09/03/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 03/26/2025; 09/10/2025
• 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