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	03/05/2026
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) 2026, it was reported by a sales representative via sems (b)(4) that an ar-1595t t-rope drill tip snapped while drilling into femur.Noticed during a case, device swapped, and case completed with no patient effect.

• 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: 24688924
• Report Number: 1220246-2026-01643
• Device Sequence Number: 9903305
• 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): 07/09/2026

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: 03/05/2026
• Supplement Date Received by Manufacturer: 07/07/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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