MAUDE Adverse Event Report: ARTHREX, INC. DRILL GUIDE, 6MM TRANSTIBIAL FEMORAL ACL; MANUAL INSTR, GENERAL SURGICAL

Model Number	DRILL GUIDE, 6MM TRANSTIBIAL FEMORAL ACL
Medical Device Problem Codes	Use of Device Problem (1670); Defective Device (2588)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
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
On (b)(6) 2025, it was reported by an arthrex employee via email that for an ar-1804, transtibial femoral acl drill guide, 6 mm, the offset guide inner core was not smooth and the drill pin was not able to slide nicely.This was detected during an acl reconstruction + let procedure on (b)(6) 2025.The procedure was completed successfully as another size offset guide was used.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided, which may include the returned device (if available), photographs, videos, event description, and any additional field input, arthrex has determined the most likely cause.The most likely cause is attributed to user-related factors such as off-axis loading, which could increase resistance.

• Brand Name: DRILL GUIDE, 6MM TRANSTIBIAL FEMORAL ACL
• 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: 23425671
• Report Number: 1220246-2025-04895
• Device Sequence Number: 9798583
• Product Code: MDM
• UDI-Device Identifier: 00888867021402
• UDI-Public: (01)00888867021402(10)021218
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 02/25/2026

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: DRILL GUIDE, 6MM TRANSTIBIAL FEMORAL ACL
• Device Catalogue Number: AR-1804
• Device Lot Number: 021218
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 10/22/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown