MAUDE Adverse Event Report: ARTHREX, INC. 3.0 X 14MM VAL SCREW, TI, STRL; BONE FIXATION SCREW/PLATE

Model Number	3.0 X 14MM 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	12/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, it was reported by an arthrex subsidiary employee via email that an ar-8933v-14s low profile va locking screw could not be locked to the plate.After drilling through the variable drill guide, the screw was inserted but failed to lock.Multiple reinsertion attempts were made, but the screw still would not lock properly.The surgery was completed using a new ar-8933v-14s low profile va locking screw.No significant surgical delay was reported, no additional anesthesia was administered, and no adverse patient effects were reported during or following the procedure.This was discovered during a procedure on (b)(6) 2025.Additional information was received on 5-jan-2026: the plate part number remains unknown; however, the same plate was used to complete the case, and only the screw was replaced.
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 the complaint allegation was confirmed.One unpackaged ar-8933v-14s batch number 15409517 was received for evaluation.Visual inspection identified missing anodized coating on the head threads, most likely resulting from an attempt to position the screw on the plate.The head threads were bent and damaged, with deformation noted at the start of the locking threads.Functional testing was performed using a well-known good plate; however, the screw could not be locked due to damage to the head threads, which prevented proper engagement.Drawing specifications at revision c6244 at revision 10, component c6244-03 at revision 7.Head major diameter: ø 0.170 + 0.001/ - 0.000 inches, result: 0.171 inches locking threads thinkness: 0.003 ± 0.005 inches, result: 0.008 inches locking threads depth measure at three different points: 0.011 ± 0.005 inches, result: 0.009,0.010 and 0.010 inches.The most likely cause of the reported failure is use error, including misalignment of the insertion, which can damage the threads and prevent the device from working as intended.

• Brand Name: 3.0 X 14MM 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: 24006641
• Report Number: 1220246-2026-00105
• Device Sequence Number: 9405724
• Product Code: HWC
• UDI-Device Identifier: 00888867210264
• UDI-Public: (01)00888867210264(11)250325(17)300228(10)15409517
• 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): 04/28/2026

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 14MM VAL SCREW, TI, STRL
• Device Catalogue Number: AR-8933V-14S
• Device Lot Number: 15409517
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2025
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2025
• 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