MAUDE Adverse Event Report: ARTHREX, INC. 3.0 X 22MM VAL SCREW, TI, STRL; BONE FIXATION SCREW/PLATE

Model Number	3.0 X 22MM VAL SCREW, TI, STRL
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 6/19/2025, it was reported via email by an arthrex subsidiary employee that during a procedure on (b)(6) 2025 involving an ar-8933v-22s low profile va locking screw, a piece of metal was observed dislodging upon screw insertion.The screw was removed and reinserted, and the procedure was successfully completed.All debris was retrieved, and no patient harm was reported.Additional information was requested on 07/03/2025: this occurred during a hallux valgus procedure on (b)(6) 2025.The case was completed by using the initial screw by removing it once and then reinserting it to complete the surgery.No case delay or added anesthesia was administered to the patient.
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 user error of the device due to applying excessive mechanical forces and/or misaligned insertion.

• Brand Name: 3.0 X 22MM VAL SCREW, TI, STRL
• Common Device Name: BONE FIXATION SCREW/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: 22520964
• Report Number: 1220246-2025-02899
• Device Sequence Number: 8827131
• Product Code: HWC
• UDI-Device Identifier: 00888867210301
• UDI-Public: (01)00888867210301(11)230817(17)280731(10)15129886
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143614
• 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: 3.0 X 22MM VAL SCREW, TI, STRL
• Device Catalogue Number: AR-8933V-22S
• Device Lot Number: 15129886
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/19/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Supplement Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown