MAUDE Adverse Event Report: ARTHREX, INC. 2.4MM CANNULATED DRILL AND PASSING WIRE; ORTHOPEDIC MANUAL SURG INSTR

Model Number	2.4MM CANNULATED DRILL AND PASSING WIRE
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2025
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 30th april 2025, it was reported by an arthrex employee via email that for an ar-1594d-24,2.4 mm cannulated drill and suturelasso¿ sd wire loop, the sd wire broke when shuttling sutures.This was detected during use in a meniscal root repair procedure on (b)(6) 2025.The procedure was completed successfully as a 2nd ar-1594d-24 was opened.
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 the most likely cause of the reported failure is user error.This includes improper bone preparation, misaligned insertion, and/or prying or levering the device during insertion, which resulted in the device breaking.The complaint allegation could not be confirmed, as the device was not received for evaluation, and no evidence of the reported failure was provided.

• Brand Name: 2.4MM CANNULATED DRILL AND PASSING WIRE
• 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: 21987171
• Report Number: 1220246-2025-01958
• Device Sequence Number: 11881610
• Product Code: LXH
• UDI-Device Identifier: 00888867365896
• UDI-Public: (01)00888867365896(11)250116(17)291231(10)15374072
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2025

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: 2.4MM CANNULATED DRILL AND PASSING WIRE
• Device Catalogue Number: AR-1594D-24
• Device Lot Number: 15374072
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 10/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2025
• 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