MAUDE Adverse Event Report: ARTHREX, INC. DRL PIN,ACL T-ROPE CLOSED EYELET,4MM; ORTHOPEDIC MANUAL SURG INSTR

Model Number	DRL PIN,ACL T-ROPE CLOSED EYELET,4MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 17 march 2025, it was reported by a sales representative via email that an ar-1595tc drl pin, acl t-rope closed eyelet,4mm was reported to have snapped off at the tip.This occurred on (b)(6) 2025 during use in an unknown procedure.There was case involvement.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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 of the reported failure can be attributed to user error due to prying/leveraging the device during use.

• Brand Name: DRL PIN,ACL T-ROPE CLOSED EYELET,4MM
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 21771997
• Report Number: 1220246-2025-01213
• Device Sequence Number: 9700728
• Product Code: LXH
• UDI-Device Identifier: 00888867019904
• UDI-Public: (01)00888867019904(11)231113(17)281031(10)15166630
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 09/03/2025

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: DRL PIN,ACL T-ROPE CLOSED EYELET,4MM
• Device Catalogue Number: AR-1595TC
• Device Lot Number: 15166630
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown