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

Model Number	DRIVER, T10 HEXALOBE, SHORT, BEVELED FT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/07/2025
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
It was reported that during a mica surgery the tip of the driver broke off.The x-ray shows that a piece of the tip remains inside the patient, a revision surgery is not planned.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-8741-40s, 3.5 mm beveled ft driver, batch number 1392419, was received for investigation.- visual inspection noted that the distal tip was broken.- functional testing was not performed due to the damage to the device.-the most likely cause can be attributed to misaligned insertion or prying/leveraging the device during use.- refer to the investigation photos.- the complaint allegation is confirmed.

• Brand Name: DRIVER, T10 HEXALOBE, SHORT, 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: 22087963
• Report Number: 1220246-2025-02200
• Device Sequence Number: 8060693
• Product Code: LXH
• UDI-Device Identifier: 00888867362642
• UDI-Public: (01)00888867362642(11)240523(10)1392419
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 08/04/2025

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, T10 HEXALOBE, SHORT, BEVELED FT
• Device Catalogue Number: AR-8741-40S
• Device Lot Number: 1392419
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown