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	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2024
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 12/31/2024, it was reported by a sales representative via phone that an ar-8906ds knotless mini tightrope® implant systems tightrope bunched up in the knotless mechanism.This occurred during a cmc arthroplasty procedure where all fragments were removed and the case continued using a second ar-8906ds knotless mini tightrope.There was no harm on the patient.This caused no more than a 30 second delay.
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: 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: 21222845
• Report Number: 1220246-2025-00066
• Device Sequence Number: 18288530
• Product Code: HTN
• UDI-Device Identifier: 00888867373983
• UDI-Public: (01)00888867373983(11)220201(17)270131(10)14920753
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/10/2025

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: 14920753
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2024
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• 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