MAUDE Adverse Event Report: ARTHREX, INC. LOW PROFILE SCREW, 1.4X12MM, CORTICAL,TI; BONE FIXATION PLATE

Model Number	LOW PROFILE SCREW, 1.4X12MM, CORTICAL,TI
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2024
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 12/9/2024, it was reported by a sales representative via (b)(4) that an ar-18714-12 cortical screw broke mid-shaft.The surgeon stated that the screw disintegrated and broke like plastic.The screw was removed, and the patient was not affected.The case was delayed twenty-five minutes as the screw kept falling apart more and more during removal.The case ended successfully after the removal and insertion of another screw from the same set.This was discovered during an orif procedure on (b)(6) 2024.Additional information received on 12/17/2024: per the sales representative, x-ray images were taken; however, they were not saved.The case was delayed about twenty minutes and additional anesthesia was administered.There were no other issues with any other arthrex product during the procedure.
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 excessive force being used during insertion of the screw and/or prying/leveraging the device during insertion.

• Brand Name: LOW PROFILE SCREW, 1.4X12MM, CORTICAL,TI
• 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: 21079440
• Report Number: 1220246-2025-09215
• Device Sequence Number: 17824590
• Product Code: HRS
• UDI-Device Identifier: 00888867303829
• UDI-Public: (01)00888867303829(11)201120(10)2755601
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K191326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2025

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: LOW PROFILE SCREW, 1.4X12MM, CORTICAL,TI
• Device Catalogue Number: AR-18714-12
• Device Lot Number: 2755601
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2020
• 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