MAUDE Adverse Event Report: ARTHREX, INC. LOW PROFILE SCREW, 1.0X9MM, CORTICAL, TI; BONE FIXATION SCREW/PLATE

Model Number	LOW PROFILE SCREW, 1.0X9MM, CORTICAL, TI
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	03/31/2025
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 3/31/2025, it was reported by a sales representative via email that two ar-18710 cortical screw head broke off.The screws were tightened with 2-finger tightness and broke as the head of the screw was making contact with the cortical bone.There was no plate used during the procedure.The surgeon located the heads of the screws and was able to remove them successfully.This was discovered during a metacarpal fracture procedure on (b)(6) 2025.Additional information requested on 4/24/2025.
Additional Manufacturer Narrative
Additional information: d6a, d6b, 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 the most likely cause.The most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: LOW PROFILE SCREW, 1.0X9MM, CORTICAL, 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: 21917264
• Report Number: 1220246-2025-01764
• Device Sequence Number: 21090388
• Product Code: HWC
• UDI-Device Identifier: 00888867303591
• UDI-Public: 00888867303591
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K193156
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2025

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, 1.0X9MM, CORTICAL, TI
• Device Catalogue Number: AR-18710-09
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 08/12/2025
• 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