MAUDE Adverse Event Report: ARTHREX, INC. CORTICAL BONE SCREW, Ø3.5MM X 32MM; FIXATN NAIL/BLADE/PLATE COMBO

Model Number	CORTICAL BONE SCREW, Ø3.5MM X 32MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	11/05/2025
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 11/06/2025, a sales representative reported via email that an 8110-032 cortical bone screw, 3.5 mm x 32 mm, snapped off during insertion with an alpha plate.The break occurred in the humerus, and the broken screw fragment was left in the patient.This issue was identified during a proximal humerus fracture procedure performed on (b)(6) 2025.
Event or Problem Description
Additional information: during the procedure, a 3025-018 alpha plate, right, 18-hole was used when an 8110-032 cortical bone screw (3.5 mm x 32 mm) fractured during insertion.No other screws were implicated, and no damage or malfunction was reported with the alpha plate.To complete the case, additional screws were used, including two ar-8935-26 low profile screw (3.5 x 26 mm) and one ar-8935 low profile screw from the titanium ankle fracture set.The surgery was delayed by approximately 45 minutes, and it is unclear whether additional anesthesia was administered during this time.The patient¿s bone quality was assessed as good, and bone preparation for implant insertion was performed using an ar-8943-30 2.5 mm drill bit from the titanium ankle fracture set.No further intervention was considered or planned to retrieve the screw fragment.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6 based on the information provided ¿ which may include the returned device (if available), photographs, videos, event description, and any additional field input ¿ arthrex has determined the most likely cause.The most likely cause is attributed to user-related factors such as mechanical overstress, off-axis loading, or improper bone preparation.

• Brand Name: CORTICAL BONE SCREW, Ø3.5MM X 32MM
• Common Device Name: FIXATN NAIL/BLADE/PLATE COMBO
• 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: 23659359
• Report Number: 1220246-2025-05229
• Device Sequence Number: 10124102
• Product Code: KTW
• UDI-Device Identifier: 00848665033236
• UDI-Public: (01)00848665033236(11)240917(10)240991
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K080590
• 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): 03/09/2026

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: CORTICAL BONE SCREW, Ø3.5MM X 32MM
• Device Catalogue Number: 8110-032
• Device Lot Number: 240991
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/17/2024
• 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