MAUDE Adverse Event Report: ARTHREX, INC. DRIVER, T10 HEXALOBE; MANUAL INSTR, GENERAL SURGICAL

Model Number	DRIVER, T10 HEXALOBE
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
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 mtp fusion surgery the threads turned on this driver due to force when inserting the screw.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
Complaint allegation is confirmed.One unpackaged, driver, t10 hexalobe, ar-8944dh, serial/batch number (b)(6), was received for investigation.Visual inspection noted that the tip of the driver was warped/twisted.Functional testing was not performed due to the damage of the device.The most likely cause for the reported failure can be attributed to wear and tear and over-torquing/over-engaging the driver reputedly over time.The manufacturing date is 2017.

• Brand Name: DRIVER, T10 HEXALOBE
• 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: 19623832
• Report Number: 1220246-2024-06457
• Device Sequence Number: 8204981
• Product Code: MDM
• UDI-Device Identifier: 00888867053045
• UDI-Public: 00888867053045
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

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
• Device Catalogue Number: AR-8944DH
• Device Lot Number: 1391744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown