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
Additional Manufacturer Narrative
The reported event was confirmed as the evaluation revealed that the drive geometry at the distal tip is twisted and therefore the screwdriver cannot grip the screw properly (see evaluation pictures 3 + 4).The complainant's event is most likely caused by over-torquing/over-engaging the driver within the screw head.
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.

• 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: 24251573
• Report Number: 1220246-2026-00386
• Device Sequence Number: 8309163
• Product Code: MDM
• UDI-Device Identifier: 00888867133747
• UDI-Public: (01)00888867133747(11)240708(10)1392421
• 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: 1392421
• 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: 07/08/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown