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); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
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 8/18/2025, it was reported by a sales representative via email that an ar-2372blo knotless ac tightrope did not hold the reduction.During the case, the clavicle and coracoid were drilled with a 3.7 mm drill and the ar-2372blo knotless ac tightrope was inserted.The coracoid button was released from the inserter and confirmed to have flipped using a c-arm.The surgeon then tensioned the tightrope by pulling on the free white strands, manually reduced the clavicle, and tensioned the clavicle button down to the superior surface.However, upon releasing manual tension, the button repeatedly slid backward and failed to hold the reduction despite multiple attempts.Due to concerns about locating the coracoid button, it was decided not to remove the tightrope.Instead, the surgeon released the luggage tag on the clavicle button, fed one of the free tensioning strands through the button and tied a knot over the top to secure it.The implant was left in the patient.This was discovered during an ac joint reconstruction procedure on (b)(6) 2025.
Event or Problem Description
Additional information received on 9/8/2025: although the button failed to hold the reduction, nothing broke inside the patient.The case experienced a 10-minute delay; however, additional anesthesia was not needed.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.Based on the information provided which may include the 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 use error.The knotless ac repair system surgical technique, lt1-000162, outlines the following in step 4: with the button firmly against the base of the coracoid, sequentially pull on the free suture limbs 1 cm to 2 cm at a time to the reduce the clavicle cup button onto the clavicle.A hemostat or blunt instrument can be placed under the clavicle cup button to aid in reduction.
Additional Manufacturer Narrative
Additional information: b5, d9, g3, h3, h6.Based on the information provided which may include the 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 use error.The knotless ac repair system surgical technique, lt1-000162, outlines the following in step 4: with the button firmly against the base of the coracoid, sequentially pull on the free suture limbs 1 cm to 2 cm at a time to the reduce the clavicle cup button onto the clavicle.A hemostat or blunt instrument can be placed under the clavicle cup button to aid in reduction.
Event or Problem Description
Additional information received on 9/8/2025: although the button failed to hold the reduction, nothing broke inside the patient.The case experienced a 10-minute delay; however, additional anesthesia was not needed.

• 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: 22993046
• Report Number: 1220246-2025-03744
• Device Sequence Number: 9619558
• Product Code: HTN
• UDI-Device Identifier: 00888867340152
• UDI-Public: (01)00888867340152(11)250604(17)300531(10)15446464
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 09/25/2025

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: 15446464
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/18/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Supplement Date Received by Manufacturer: 09/25/2025; 09/25/2025
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 09/25/2025; 09/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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