MAUDE Adverse Event Report: ARTHREX, INC. 1.8MM PERC INSERT KIT FOR FIBERTAK; MANUAL INSTR, GENERAL SURGICAL

Model Number	1.8MM PERC INSERT KIT FOR FIBERTAK
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/11/2024, it was reported by a sales representative via email that an ar-3610pk-3 fibertak percutaneous insertion kit had a switching stick not fully cannulated and the nitinol wire could not advance.This was discovered during a labral repair procedure on (b)(6) 2024.
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 for the reported failure can be attributed to user error of the device due to misaligned insertion.

• Brand Name: 1.8MM PERC INSERT KIT FOR FIBERTAK
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 21102742
• Report Number: 1220246-2025-09277
• Device Sequence Number: 20996911
• Product Code: LXH
• UDI-Device Identifier: 00888867358225
• UDI-Public: (01)00888867358225(11)240926(17)290831(10)15322865
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2025

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: 1.8MM PERC INSERT KIT FOR FIBERTAK
• Device Catalogue Number: AR-3610PK-3
• Device Lot Number: 15322865
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2024
• 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