MAUDE Adverse Event Report: ARTHREX, INC. VA LOCKING SCREW, 1.4X9MM; BONE FIXATION PLATE

Model Number	VA LOCKING SCREW, 1.4X9MM
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 5/16/2025, a sales representative reported via phone that qty.2 of an ar-18714v-09 val screw, 1.4 mm x 9 mm, had an issue during a metacarpal fracture repair procedure on (b)(6) 2025.When the surgeon was trying to insert two of those screws into the locking plate, both screws would not lock into the locking plate.Both screws were removed in one piece from the patient, nothing broke, and there was no harm.An ar-18714-09 cortical screw, 1.4 mm x 9 mm with an unknown lot was used to complete the procedure successfully.The complaint devices were available for return.There was no case delay reported, and no additional anesthesia was administered.This occurred during use with no reported patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.-upon visual inspection, the screw single-use device was used/damaged/removed and returned for investigation because it did not lock into the plate.It was observed that the screw had nicks around the threads/threads head of the val screw, 1.4 mm x 9 mm.-dimensional inspection was conducted in accordance with drawing c12860-04, and all measured values were found to be within specified tolerances.(refer to dimension results for details.) -functional testing was not performed due to the damage to the device.Dfu-0125-eo b.Indications - the arthrex mini cfs screws (1.4-1.6 mm solid) are intended for use in selective trauma, reconstructive procedures, and general surgery of the hand, wrist, and other small bones.The mini cfs screws are to be used with the arthrex mini cfs plates (1.4-1.6 mm).The most likely cause of the reported failure can be attributed to user error in the device, which is related to not following the instructions that the mini cfs screws are to be used with the arthrex mini cfs plates (1.4-1.6 mm).

• Brand Name: VA LOCKING SCREW, 1.4X9MM
• 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: 22149167
• Report Number: 1220246-2025-02386
• Device Sequence Number: 20741697
• Product Code: HRS
• UDI-Device Identifier: 00888867303713
• UDI-Public: (01)00888867303713(11)210315(10)1102793
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2025

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, 1.4X9MM
• Device Catalogue Number: AR-18714V-09
• Device Lot Number: 1102793
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 09/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2021
• 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