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	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 10/25/2023, it was reported by a sales representative via email that the tightrope from an ar-2370bl knotless ac tightrope repair implant with dog bone button got jammed.The surgeon drilled the tunnels through the clavicle and coracoid, and an sd wire loop was passed.The knotless ac tightrope was passed, and a dog bone button was attached.The dog bone button was placed on the coracoid, and the clavicle button was walked down to the clavicle, but before the clavicle button was tight to the clavicle, the tightrope got jammed.The surgeon used kite handles to pull on the tightrope tails with force while the physician assistant held the reduction on the clavicle.After pulling on it hard, the button did not get tight to the clavicle and the white pull suture on one of the kite handles snapped right at the tightrope mechanism.The surgeon cut the clavicle button off and used the sutures to pass another tightrope to complete the case without further issues.This was discovered during an ac joint reconstruction procedure on (b)(6) 2023.
Additional Manufacturer Narrative
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: emily shafer ; 8009337001
• MDR Report Key: 18184400
• Report Number: 1220246-2023-08847
• Device Sequence Number: 12692039
• Product Code: HTN
• UDI-Device Identifier: 00888867340138
• UDI-Public: 00888867340138
• 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): 01/16/2025

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: 15100592
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2023
• Supplement Date Received by Manufacturer: 12/23/2024
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2023
• 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