MAUDE Adverse Event Report: ARTHREX, INC. 2.4 X 18MM VAL SCREW, TI, STERILE; BONE FIXATION PLATE

Model Number	2.4 X 18MM VAL SCREW, TI, STERILE
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 10/06/2025, an arthrex subsidiary employee reported via email that an ar-8724v-18s low profile va locking screw did not lock into the plate and became stuck halfway through.The screw was successfully removed.The case was completed by using the same product, a replacement ar-8724v-18s low profile va locking screw, with no issues reported.There was no detailed information on the type of surgery.There was no significant delay, no additional anesthesia was administered, and no adverse effects were reported.No photos were taken of the event.The event occurred during a procedure performed on (b)(6) 2025, with no patient harm reported.Additional information was received on 10/09/2025: there was no report of breakage of the ar-8724v-18s low profile va locking screw when the issue occurred.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.Based on the information provided ¿ which may include the returned device (if available), photographs, videos, event description, and any additional field input ¿ arthrex has concluded a most likely cause.The most likely cause can be attributed misuse due to improper bone preparation; misaligned insertion; or prying/leveraging the screw during insertion.
Event or Problem Description
Additional information was received on 10/20/2025: only a replacement ar-8724v-18s low profile va locking screw was required to complete the case, using the original plate without the need for a new plate.

• Brand Name: 2.4 X 18MM 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: jared engle ; 8009337001
• MDR Report Key: 23311102
• Report Number: 1220246-2025-04641
• Device Sequence Number: 5814805
• Product Code: HRS
• UDI-Device Identifier: 00888867209794
• UDI-Public: (01)00888867209794(11)240327(17)290228(10)15225952
• 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): 11/13/2025

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: 2.4 X 18MM VAL SCREW, TI, STERILE
• Device Catalogue Number: AR-8724V-18S
• Device Lot Number: 15225952
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Supplement Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown