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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the most likely cause.The most likely cause of the reported failure is user error, including incorrect surgical technique during device application.These factors may have contributed to the malfunction or compromised the integrity of the implant during the procedure.The device was not received for evaluation.
Event or Problem Description
It was reported that during a surgery the implant did not hold.No further information received.Update dw 20-nov-2025: further information was provided that the first arthrex employee became aware of this issue on 28th october 2025.It was further reported that the issue occurred during a shoulder surgery.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update dw 21-nov-2025: further information was provided that the reported device has the batch 15446460.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Visual inspection, reveals that the edges around the threaded area of the button were chipped/damaged.Threads at the distal end of the shaft were stripped.The button was returned disassembled from the shaft.Functional testing was not performed due to the damage to the device.Per surgical technique - lt1-000162-en - 1-through an open or mini-open incision, drill a 3.7 mm tunnel through both the clavicle and coracoid.Fluoroscopy can be used to confirm proper tunnel placement.The method of bone preparation and the quality of the bone encountered were not specified.The most likely cause of the reported failure is attributed to user error resulting from improper surgical technique.Contributing factors may include inadequate bone preparation, misalignment/prying or leveraging of the device during insertion, which could lead to the button separating or disengaged from the shaft.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Visual inspection, reveals that the edges around the threaded area of the button were chipped/damaged.Threads at the distal end of the shaft were stripped.The button was returned disassembled from the shaft.Functional testing was not performed due to the damage to the device.Per surgical technique - lt1-000162-en - 1-through an open or mini-open incision, drill a 3.7 mm tunnel through both the clavicle and coracoid.Fluoroscopy can be used to confirm proper tunnel placement.The method of bone preparation and the quality of the bone encountered were not specified.The most likely cause of the reported failure is attributed to user error resulting from improper surgical technique.Contributing factors may include inadequate bone preparation, misalignment/prying or leveraging of the device during insertion, which could lead to the button separating or disengaged from the shaft.

• 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: 23657357
• Report Number: 1220246-2025-05215
• Device Sequence Number: 4903319
• Product Code: HTN
• UDI-Device Identifier: 00888867340152
• UDI-Public: (01)00888867340152(11)250604(17)300531(10)15446460
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K220947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/06/2026

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: KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLAN
• Device Catalogue Number: AR-2372BLO
• Device Lot Number: 15446460
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 10/28/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 02/17/2026; 03/04/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 02/19/2026; 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown