MAUDE Adverse Event Report: ARTHREX, INC. 3.0 X 18MM VAL SCREW, TI; BONE FIXATION SCREW/PLATE

Model Number	3.0 X 18MM VAL SCREW, TI
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthrodesis surgery with a 3.0 plate the screw broke during insertion.The screw remained in the patient and the broken part was retrieved.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.
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 confirmed.Upon visual inspection, it was noted that the head returned of the low-profile screw 3.0 x 18mm was broken off from the device.Functional testing was not performed due to the damage to the device.The method of bone preparation and the quality of the bone encountered were not specified.Per dfu-0125-eo g.Precautions - 4.Damage to the driver or screw may result from failure to seat the driver fully into the screw or to align the driver properly with the screw.The most likely cause of the reported failure can be attributed to user error, specifically due to improper misaligned insertion; prying/leveraging and/or user-applied excessive mechanical forces during insertion of the screw implant.

• Brand Name: 3.0 X 18MM VAL SCREW, TI
• 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: 21539832
• Report Number: 1220246-2025-00836
• Device Sequence Number: 7687995
• Product Code: HWC
• UDI-Device Identifier: 00888867050242
• UDI-Public: 00888867050242
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 08/26/2025

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 18MM VAL SCREW, TI
• Device Catalogue Number: AR-8933V-18
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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