MAUDE Adverse Event Report: ARTHREX, INC. 2.4 X 14MM VAL SCREW, TI, STERILE; BONE FIXATION PLATE

Model Number	2.4 X 14MM VAL SCREW, TI, STERILE
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 11/21/2023, it was reported by an arthrex subsidiary employee via email that an ar-8724v-14s low profile va locking screw, 2.4 x 14 mm would not lock into an ar-8916vsl-03s volar distal radius plate.A new ar-8724v-14s low profile va locking screw, 2.4 x 14 mm was used to complete the case.This was discovered during a procedure on (b)(6) 2023.
Additional Manufacturer Narrative
The complaint cannot be confirmed due to the device being unable to be visually and functionally evaluated.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 reason for the reported failure is user error misalignment the insertion.

• Brand Name: 2.4 X 14MM VAL SCREW, TI, STERILE
• 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: emily shafer ; 8009337001
• MDR Report Key: 18358422
• Report Number: 1220246-2023-09486
• Device Sequence Number: 7771734
• Product Code: HRS
• UDI-Device Identifier: 00888867209770
• UDI-Public: 00888867209770
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131474
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2025

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: 2.4 X 14MM VAL SCREW, TI, STERILE
• Device Catalogue Number: AR-8724V-14S
• Device Lot Number: 15001605
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2023
• Supplement Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2022
• 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
• Patient Sex: Unknown