MAUDE Adverse Event Report: ARTHREX, INC. KNOTLESS MINI TR IMPLANT, 1.1MM, TI; WASHER, BOLT, NUT

Model Number	KNOTLESS MINI TR IMPLANT, 1.1MM, TI
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 02/13/2024, it was reported by a sales representative via e-mail that an ar-8906ds knotless mini tightrope® implant bunched up when shuttling.This occurred during a case where they used the link pull suture to shuttle, not the tightrope tensioning sutures.
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.
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 descriptions, and any additional information from the field, arthrex concluded that the most likely cause of the reported failure is user error, improper surgical technique.The complaint allegation was confirmed based on the customer's attached picture, which showed an irregularity in the suture loop.

• Brand Name: KNOTLESS MINI TR IMPLANT, 1.1MM, TI
• 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: 18873927
• Report Number: 1220246-2024-01397
• Device Sequence Number: 11632717
• Product Code: HTN
• UDI-Device Identifier: 00888867373983
• UDI-Public: 00888867373983
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K213644
• 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): 06/04/2025

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 MINI TR IMPLANT, 1.1MM, TI
• Device Catalogue Number: AR-8906DS
• Device Lot Number: 15005211
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2024
• Supplement Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2022
• 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