MAUDE Adverse Event Report: ARTHREX, INC. 3.0 X 12MM VAL SCREW, TI, STRL; BONE FIXATION SCREW/PLATE

Model Number	3.0 X 12MM VAL SCREW, TI, STRL
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
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 (b)(6) 2025, an arthrex subsidiary employee reported via email that two distal screws, ar-8933v-10s low profile va locking screw (3 x 10 mm) and ar-8933v-12s low profile va locking screw (3 x 12 mm), failed to lock and rotated freely when used with a lateral hook plate.No breakage occurred.Although four screws were planned, the procedure was completed with only two screws inserted.The affected screws were not implanted.There was no significant surgical delay, no additional anesthesia administered, and no adverse patient effects reported.This was discovered during a procedure on (b)(6) 2025, with no reported patient harm.Additional information was requested on 22-dec-2025.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported failure is a use error, including excessive force and/or improper surgical technique associated with the device.The complaint allegation was not confirmed.No evidence of that failure was received.
Event or Problem Description
Additional information: the issue occurred while the device was inside the patient.There was no cross-threading or stripping reported on the two distal screws, which were removed without difficulty.No damage was observed on the lateral hook plate, and the initial lateral hook plate remained implanted.No additional surgery is planned.

• Brand Name: 3.0 X 12MM 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: 24004231
• Report Number: 1220246-2026-00097
• Device Sequence Number: 16082939
• Product Code: HWC
• UDI-Device Identifier: 00888867210257
• UDI-Public: (01)00888867210257(11)240819(17)290731(10)15304249
• 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): 04/20/2026

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 12MM VAL SCREW, TI, STRL
• Device Catalogue Number: AR-8933V-12S
• Device Lot Number: 15304249
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 12/18/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown