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 Codes	Positioning Failure (1158); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, a sales representative reported via phone that an ar-2372blo knotless ac tightrope open repair implant with pec button would not tension and failed to achieve ac joint reduction.The surgeon ultimately cut and removed the implant and tied the graft over the construct.The case was delayed approximately five minutes, with no additional anesthesia administered.The issue occurred during a clavicle orif and ac joint stabilization procedure with internal open reduction performed on (b)(6) 2026.No patient harm was reported.
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 returned device (if available), photographs, videos, event description, and any additional field input arthrex has determined the most likely cause.The most likely cause is attributed to user-related factors, such as if the 3.7 mm tunnels through the clavicle and coracoid are not properly aligned, the implant may not seat correctly, preventing effective tensioning and reduction.

• 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: 24251816
• Report Number: 1220246-2026-00388
• Device Sequence Number: 8309646
• Product Code: HTN
• UDI-Device Identifier: 00888867340152
• UDI-Public: (01)00888867340152(11)250806(17)300731(10)15478356
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 05/18/2026

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: 15478356
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/14/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown