MAUDE Adverse Event Report: ARTHREX, INC. KL AC TIGHTROPE REPAIR IMP. W/DOG BONE; WASHER, BOLT, NUT

Model Number	KL AC TIGHTROPE REPAIR IMP. W/DOG BONE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 4/17/2025, it was reported by a sales representative via email that an ar-2370bl knotless ac tightrope with dog bone button repair system was involved in an intraoperative issue during an ac reconstruction procedure on (b)(6) 2025.During the surgery, the surgeon drilled through the clavicle and coracoid using an ar-2257d-30 drill and passed a passing wire.The tightrope was placed, and the dog bone button was secured onto the coracoid.However, while attempting to tighten the tightrope, the surgeon encountered difficulty getting it to slide properly.Upon applying additional force, the pull suture snapped at the tightrope mechanism.As a result, the surgeon had to cut the tightrope off the clavicle side and remove the dog bone button from beneath the coracoid.The components were fully removed, and the ac reconstruction was completed using an ar-2370bl knotless ac tightrope with dog bone button repair system.The issue caused approximately a two-minute delay, but no additional anesthesia was administered, as confirmed by the crna in the operating room.
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 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 misuse/mishandling due to damage to the device.

• Brand Name: KL AC TIGHTROPE REPAIR IMP. W/DOG BONE
• 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: 22008492
• Report Number: 1220246-2025-02019
• Device Sequence Number: 20829572
• Product Code: HTN
• UDI-Device Identifier: 00888867340138
• UDI-Public: (01)00888867340138(11)230808(17)280731(10)15125666
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 09/23/2025

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: KL AC TIGHTROPE REPAIR IMP. W/DOG BONE
• Device Catalogue Number: AR-2370BL
• Device Lot Number: 15125666
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown