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

Model Number	DRL PIN,ACL T-ROPE OPEN EYELET,4MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
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 12/01/2025, a distributor reported via (b)(4) that an ar-1595t acl tightrope open eyelet spade tip broke during malleting into the femur during an acl procedure.This was completed successfully with no patient harm.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the provided information, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional field data, arthrex concluded that the most likely cause of the reported failure is user error.This includes misaligned insertion, and/or prying or levering the device during insertion, which resulted in the device breaking and/or being damaged.The complaint allegation could not be confirmed upon reviewing the customer¿s attached photograph, which appears to show the broken portion of the reported ar-1595t drill pin, acl tightrope®, open eyelet, 4 mm.However, the image quality is insufficient to clearly determine which side of the pin was fractured.Appears to be the back of the pin (eyelet), not the tip.

• Brand Name: DRL PIN,ACL T-ROPE OPEN 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: 23863253
• Report Number: 1220246-2025-05746
• Device Sequence Number: 10066879
• Product Code: LXH
• UDI-Device Identifier: 00888867019898
• UDI-Public: (01)00888867019898(11)250804(17)300731(10)15476976
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2026

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: DRL PIN,ACL T-ROPE OPEN EYELET,4MM
• Device Catalogue Number: AR-1595T
• Device Lot Number: 15476976
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2025
• 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