MAUDE Adverse Event Report: ARTHREX, INC. CANNULATED HEX DRIVER, 2.5MM X 7" LONG; MANUAL INSTR, GENERAL SURGICAL

Model Number	CANNULATED HEX DRIVER, 2.5MM X 7" LONG
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2023
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
On the 8th december 2023, it was reported by a arthrex rep.Via email that for an ar-7000-13, (cannulated hex driver, 2.5 mm x 7 '' long) the screwdriver shaft was found to be too stripped to engage properly with the 3.75 latarjet screws.This was detected during use in a latarjet procedure on 5th december 2023.The case was completed successfully with a non-arthrex screwdriver to complete insertion of the screws.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause is attributed to user error of the device due to over-torquing/over-engaging the driver within the screw head.Manufactured date 2019.

• Brand Name: CANNULATED HEX DRIVER, 2.5MM X 7" LONG
• 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: emily shafer ; 8009337001
• MDR Report Key: 18437219
• Report Number: 1220246-2024-00043
• Device Sequence Number: 12535767
• Product Code: MDM
• UDI-Device Identifier: 00888867040892
• UDI-Public: 00888867040892
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 01/31/2025

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: CANNULATED HEX DRIVER, 2.5MM X 7" LONG
• Device Catalogue Number: AR-7000-13
• Device Lot Number: 021921
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2023
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown