MAUDE Adverse Event Report: ARTHREX, INC. T20 HEXALOBE DRIVER; MANUAL INSTR, GENERAL SURGICAL

Model Number	T20 HEXALOBE DRIVER
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgery the screwdrivers were heavily worn.Per complaint reporter there was no harm for patient, operator or third party.No further information received.Update 14-jan-2026: the reported devices arrived at arthrex gmbh and during an initial inspection of the devices it was notices that the tip of the device ar-8970-03 (lot: 1392436) is broken off.Update 27-jan-2026: it was confirmed that no fragments remained inside the patient and the device might have broken during surgery.
Additional Manufacturer Narrative
The reported event was confirmed as one unpackaged ar-8970-03, t20 hexalobe driver, batch number 1392436, was received for investigation and the evaluation revealed that a part of the hexalobe tip is broken off (see evaluation pictures 3 + 4).Functional testing was not performed due to the damage of the device.No fragments were returned for evaluation.The most likely cause for the reported failure can be attributed to user error of the device due to prying/leveraging the driver while engaged with the screw and/or over-torquing/over-engaging the driver with the screw head.

• Brand Name: T20 HEXALOBE DRIVER
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 24251575
• Report Number: 1220246-2026-00387
• Device Sequence Number: 18220023
• Product Code: MDM
• UDI-Device Identifier: 00888867133747
• UDI-Public: (01)00888867133747(11)240916(10)1392436
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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
• Report Date (Section B): 02/03/2026

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: T20 HEXALOBE DRIVER
• Device Catalogue Number: AR-8970-03
• Device Lot Number: 1392436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2026
• Distributor Facility Aware Date: 01/14/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown