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

Model Number	DRIVER SHAFT, T-15, SHORT
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/21/2025
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 02/21/2025, a sales representative reported via (b)(4) that an ar-9545-t15-01 driver shaft did not function.This occurred in a case, they had a spare driver and completed the case without incident or delay.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 the complaint allegation is confirmed.One unpackaged ar-9545-t15-01, serial/batch number (b)(6), was received for evaluation.A visual evaluation found that the instrument's hex had nicks and was twisted.Functional testing cannot be performed due to the damage to the hex tip, which can potentially damage a mating part.The most likely reason for the reported failure is a user error or excessive force during use.

• Brand Name: DRIVER SHAFT, T-15, SHORT
• 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: 21571921
• Report Number: 1220246-2025-00870
• Device Sequence Number: 8737989
• Product Code: LXH
• UDI-Device Identifier: 00888867225183
• UDI-Public: 00888867225183
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/15/2025

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 SHAFT, T-15, SHORT
• Device Catalogue Number: AR-9545-T15-01
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2025
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 04/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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