MAUDE Adverse Event Report: ARTHREX, INC. 2.4 X 22MM VAL SCREW, TI, STERILE; BONE FIXATION PLATE

Model Number	2.4 X 22MM VAL SCREW, TI, STERILE
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 08/07/2025, an arthrex subsidiary employee reported via email that an ar-8724v-22s low profile va locking screw penetrated the ar-8924vsl-03s 2.4 mm volar distal radius plate, including its screw head, during insertion into the bone hole.The surgeon removed the screw and inserted a new one into the same bone hole, successfully achieving fixation.The removed screw was then reused in a different bone hole and was fixed without issue.No implant components broke off inside the patient, and no adverse effects were reported.This event occurred during a procedure on (b)(6) 2025.Additional information was received on 08/15/2025: this event occurred during a distal radius fracture repair procedure on (b)(6) 2025.A replacement ar-8724v-22s low profile va locking screw (lot is unknown) was inserted after the original screw penetrated the plate and was removed.There was no significant delay to the procedure, and no additional anesthesia was administered.It was also confirmed that no other products were involved in this event.
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.Complaint allegation is not confirmed.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 of the reported failure can be attributed to user error of the device due to excessive force being used during insertion of the screw.

• Brand Name: 2.4 X 22MM 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: 22883364
• Report Number: 1220246-2025-03613
• Device Sequence Number: 9604674
• Product Code: HRS
• UDI-Device Identifier: 00888867209817
• UDI-Public: (01)00888867209817(11)220418(17)270331(10)14951407
• 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): 10/20/2025

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 22MM VAL SCREW, TI, STERILE
• Device Catalogue Number: AR-8724V-22S
• Device Lot Number: 14951407
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown