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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery to treat an acromioclavicular joint separation, the button of the tightrope detached from the implant holder after passing through the clavicle and before passing through the acromion.No fragments remained in the patient.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.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• 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: 24817083
• Report Number: 1220246-2026-02066
• Device Sequence Number: 9693551
• Product Code: HTN
• UDI-Device Identifier: 00888867340152
• UDI-Public: (01)00888867340152(11)250604(17)300531(10)15446462
• 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
• Report Date (Section B): 06/16/2026

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: 15446462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 06/16/2026
• 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