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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a knee surgery the tips of both pins ar-1595tc (lot: 15458338 and 15461606) broke during use.All fragments were retrieved from the patient.Per complaint reporter 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
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• 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: 23888340
• Report Number: 1220246-2025-05806
• Device Sequence Number: 18507760
• Product Code: LXH
• UDI-Device Identifier: 00888867019904
• UDI-Public: (01)00888867019904(11)250630(17)300531(10)15458338
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 12/24/2025

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: 15458338
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2025
• 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