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	Insufficient Information (4580)
Date of Event	12/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/5/2024, it was reported by a sales representative via email that an ar-8906ds knotless mini tightrope suture on the metatarsal side would not shorten the construct.The other limb would shorten, but one would not so the button could not reduce to the first metatarsal.The suture was pulled again and ended up snapping before reducing at all.This was discovered during a procedure on (b)(6) 2024.The case was completed by opening another ar-8906ds knotless mini tightrope.Additional information received on 12/12/2024: this was discovered during a hallux valgus correction procedure.The anchor was removed, and the case was delayed two minutes.
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 user error of the device due to excessive force used during suture passing/tightening /tensioning.

• 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: 21060750
• Report Number: 1220246-2025-09180
• Device Sequence Number: 7947307
• 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: NY
• 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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2024
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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