MAUDE Adverse Event Report: ARTHREX, INC. KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLAN; WASHER, BOLT, NUT

Model Number	KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLAN
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a sales representative reported via sems-07010204 that (2) ar-2372blo knotless ac tightrope® open repair implants pec button deployed too early both times.This occurred during use.
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.Complaint allegation is not confirmed.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 misalignment insertion, and/or prying/leveraging of the device during insertion.

• Brand Name: KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLAN
• Common Device Name: WASHER, BOLT, NUT
• 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: 22859806
• Report Number: 1220246-2025-03568
• Device Sequence Number: 18075725
• Product Code: HTN
• UDI-Device Identifier: 00888867340152
• UDI-Public: 00888867340152
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K220947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2025

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: KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLAN
• Device Catalogue Number: AR-2372BLO
• Device Lot Number: 15205812
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Supplement Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown