MAUDE Adverse Event Report: ARTHREX, INC. DRIVER SHAFT, T-15, MEDIUM; ORTHOPEDIC MANUAL SURG INSTR

Model Number	DRIVER SHAFT, T-15, MEDIUM
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
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 (b)(6), a sales representative reported via sems-(b)(4) that the ar-9545-t15-02 t-15 driver shaft is twisted.This issue was discovered after a case with no patient harm.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint is confirmed.One unpackaged ar-9545-t15-02 batch 1392329 was received for investigation.Upon visual inspection, it was noted that the driver geometry at the distal tip had twisted, and circular lines were noted close to the tip.A functional test was not performed due to the damage to the distal tip.It was not indicated if the device had been used with a torque-indicating adapter.The most likely cause of this failure is wear and tear from repeatedly torquing/engaging the driver within the screw head, and the extended field use manufacturing date of 2023.

• Brand Name: DRIVER SHAFT, T-15, MEDIUM
• 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: 24621804
• Report Number: 1220246-2026-01477
• Device Sequence Number: 13302991
• Product Code: LXH
• UDI-Device Identifier: 00888867225190
• UDI-Public: (01)00888867225190(11)230803(10)1392329
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 05/05/2026

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: DRIVER SHAFT, T-15, MEDIUM
• Device Catalogue Number: AR-9545-T15-02
• Device Lot Number: 1392329
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 02/25/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown