MAUDE Adverse Event Report: ARTHREX, INC. LOW PROFILE SCREW, 2.0 X 18MM, CORTICAL; BONE FIXATION SCREW/PLATE

Model Number	LOW PROFILE SCREW, 2.0 X 18MM, CORTICAL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/17/2025
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 07/22/2025, a sales representative reported via phone that an ar-18720-20 cortical screw and an ar-18720-18 cortical screw broke.This occurred during a pilon fracture on (b)(6) 2025.The screw remains in the patient, who had normal bone quality.There was no delay in the procedure, and no additional anesthesia was administered.The case was completed using a larger screw in the set.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional field information, arthrex was able to determine the most likely cause.The most likely cause(s) for the reported failure can be attributed to user error, improper bone preparation, misaligned insertion, or excessive forces through leveraging/prying the device.The complaint allegation could not be confirmed, as the device was not received for evaluation, and no evidence of the reported failure was provided.

• Brand Name: LOW PROFILE SCREW, 2.0 X 18MM, CORTICAL
• 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: 22751334
• Report Number: 1220246-2025-03375
• Device Sequence Number: 8716145
• Product Code: HRS
• UDI-Device Identifier: 00888867311763
• UDI-Public: 00888867311763
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K220937
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2025

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, 2.0 X 18MM, CORTICAL
• Device Catalogue Number: AR-18720-18
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown