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

Model Number	KNOTLESS AC TIGHTROPE REPAIR SYSTEM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
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 04/15/2025, a sales representative reported via email that an ar-2371bl knotless ac tightrope repair system encountered an issue during tensioning the clavicle cup button.The suture ripped, preventing the final tensioning and necessitating a different anchor kit.No further details were provided.This was discovered during a procedure.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: b5, g3, h6.
Event or Problem Description
Additional information was received on 05/14/2025: this occurred during an ac joint reconstruction procedure on (b)(6) 2025.All fragments were successfully retrieved from the patient.Another ar-2371bl knotless ac tightrope repair system was used to complete the case.The procedure proceeded without delay, and no additional anesthesia was required.No adverse effects on the patient were reported on or after the procedure.
Additional Manufacturer Narrative
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 excessive user-applied mechanical forces.

• Brand Name: KNOTLESS AC TIGHTROPE REPAIR SYSTEM
• 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: 22001686
• Report Number: 1220246-2025-01987
• Device Sequence Number: 9164260
• Product Code: HTN
• UDI-Device Identifier: 00888867340145
• UDI-Public: (01)00888867340145(11)241028(17)290930(10)15338708
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K220947
• 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,Followup
• Report Date (Section B): 09/24/2025

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: KNOTLESS AC TIGHTROPE REPAIR SYSTEM
• Device Catalogue Number: AR-2371BL
• Device Lot Number: 15338708
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/15/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 05/14/2025; 09/18/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 06/04/2025; 09/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown