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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
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 07/18/2025, it was reported by a sales representative via (b)(4) that an ar-9545-t15-02 driver shaft tip of screwdriver was torqued and broke at the head of the screw while trying to remove the central screw from the cug baseplate.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
Additional information: one unpackaged ar-9545-t15-02, batch: 8001828, was returned for evaluation.Visual inspection found that the instrument's hex tip was twisted/damaged.The most likely cause of the reported failure is user error, which involves over-torquing or over-engaging the driver with the screw head.No functional testing was performed due to the physical damage of the device's tip.Refer to the investigation photos.Complaint allegation is confirmed.

• 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: 22737867
• Report Number: 1220246-2025-03309
• Device Sequence Number: 7218468
• Product Code: LXH
• UDI-Device Identifier: 00888867225190
• UDI-Public: (01)00888867225190(11)180724(10)8001828
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• 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): 09/26/2025

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, MEDIUM
• Device Catalogue Number: AR-9545-T15-02
• Device Lot Number: 8001828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown