MAUDE Adverse Event Report: ARTHREX, INC. VA LOCKING SCREW, 1.4X8MM; BONE FIXATION PLATE

Model Number	VA LOCKING SCREW, 1.4X8MM
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 06/06/2024 it was reported by a sales representative via e-mail that an ar-18700-09 driver shaft and an ar-18700-29 driver shafts tips broke off.This occurred during a case where the drivers broke off into the ar-18714v-08 screw head in the ar-18714p-12 plate.One of the tips from an ar-18700-29 driver could not be retrieved as it cold welded to the screw.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
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 improper bone preparation and/or prying/leveraging the screw during insertion.

• Brand Name: VA LOCKING SCREW, 1.4X8MM
• Common Device Name: BONE FIXATION 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: 19668442
• Report Number: 1220246-2024-06573
• Device Sequence Number: 6918022
• Product Code: HRS
• UDI-Device Identifier: 00888867303720
• UDI-Public: 00888867303720
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K191326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,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: VA LOCKING SCREW, 1.4X8MM
• Device Catalogue Number: AR-18714V-08
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2024
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown