MAUDE Adverse Event Report: ARTHREX, INC. T10 HEXALOBE, CMP FT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	T10 HEXALOBE, CMP FT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
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-mar-2026, a facility representative reported via (b)(4) that an ar-8737-38 t10 hexalobe shaft broke during a hardware removal.No patient was affected.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 one unpackaged ar-8737-38 t10 hexalobe driver, batch 5038841, was received for investigation.Visual evaluation found that the tip of the device was twisted and fractured.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user-related factors such as excessive torque application.The complaint allegation is confirmed.Refer to the investigation photos.

• Brand Name: T10 HEXALOBE, CMP FT
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 24792054
• Report Number: 1220246-2026-01961
• Device Sequence Number: 18344566
• Product Code: LXH
• UDI-Device Identifier: 00888867127166
• UDI-Public: (01)00888867127166(11)250807(10)5038841
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2026

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: T10 HEXALOBE, CMP FT
• Device Catalogue Number: AR-8737-38
• Device Lot Number: 5038841
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 04/06/2026
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown