MAUDE Adverse Event Report: ARTHREX, INC. DRIVER, T8 HEXALOBE SELF RETAINING; MANUAL INSTR, GENERAL SURGICAL

Model Number	DRIVER, T8 HEXALOBE SELF RETAINING
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
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 10/24/2025, it was reported by a facility representative via (b)(4) that an ar-8916-27 driver is not holding the screws.Discovered during a case with no patient effect.

• Brand Name: DRIVER, T8 HEXALOBE SELF RETAINING
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 23451922
• Report Number: 1220246-2025-04960
• Device Sequence Number: 20847298
• Product Code: MDM
• UDI-Device Identifier: 00888867177628
• UDI-Public: (01)00888867177628(11)241206(10)1392442
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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
• Report Date (Section B): 11/03/2025

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: DRIVER, T8 HEXALOBE SELF RETAINING
• Device Catalogue Number: AR-8916-27
• Device Lot Number: 1392442
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown