MAUDE Adverse Event Report: ARTHREX, INC. DRIVER, T15 HEXALOBE, BEVELED FT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	DRIVER, T15 HEXALOBE, BEVELED FT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a screw removal surgery after a minimally invasive chevron akin (mica) the screwdriver broke off under load.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a different device.It was not necessary to do a second surgery.
Additional Manufacturer Narrative
The complaint allegation is confirmed based on the customer-provided picture.Visual evaluation of the customer provided photo noted an ar-8741-42 cannulated, t15 hexalobe 4.0 mm beveled ft driver with a damaged tip.Based on the information provided which may include pictures, videos, the event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to applying excessive mechanical forces, over-torquing/over-engaging the driver with the screw head and/or prying/leveraging the driver while engaged with the screw.
Additional Manufacturer Narrative
Additional information: d4, g3, h3, h6.Lot# 1392332 provided.The complaint allegation is confirmed based on the customer-provided picture.Visual evaluation of the customer provided photo noted an ar-8741-42 cannulated, t15 hexalobe 4.0 mm beveled ft driver with a damaged tip.Based on the information provided which may include pictures, videos, the event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to applying excessive mechanical forces, over-torquing/over-engaging the driver with the screw head and/or prying/leveraging the driver while engaged with the screw.

• Brand Name: DRIVER, T15 HEXALOBE, BEVELED 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: 22736652
• Report Number: 1220246-2025-03300
• Device Sequence Number: 17939371
• Product Code: LXH
• UDI-Device Identifier: 00888867362659
• UDI-Public: 00888867362659
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2025

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, T15 HEXALOBE, BEVELED FT
• Device Catalogue Number: AR-8741-42
• Device Lot Number: 1392332
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown