MAUDE Adverse Event Report: ARTHREX, INC. K-LESS T-ROPE W/DRV, SYN REPR, TI; WASHER, BOLT, NUT

Model Number	K-LESS T-ROPE W/DRV, SYN REPR, TI
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, it was reported by an arthrex subsidiary employee via email that an ar-8925t syndesmosis tightrope xp button was not attached to the inserter.The surgeon could not reattach the button on the inserter, as this was noticed during insertion into the bone tunnel.The button was attached by the sutures and never loose in the patient.The case was completed using another r-8925t syndesmosis tightrope xp.This was discovered during a syndesmosis repair procedure on (b)(6) 2024.The case was not delayed.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.Upon visual inspection, it was noted that the tip of the rod, inserter handle of the syndesmosis tightrope® xp, titanium had bent.The button returned was not attached to the tip.The shaft was observed to have abrasion marks.Functional testing was not performed with the button due to damage to the tip of the rod.The most likely cause of the reported failure is a user error of the device due to misalignment insertion, and/or prying/leveraging of the device during insertion.

• Brand Name: K-LESS T-ROPE W/DRV, SYN REPR, 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: 20193372
• Report Number: 1220246-2024-07527
• Device Sequence Number: 7535467
• Product Code: HTN
• UDI-Device Identifier: 00888867281608
• UDI-Public: 00888867281608
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K043248
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2025

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: K-LESS T-ROPE W/DRV, SYN REPR, TI
• Device Catalogue Number: AR-8925T
• Device Lot Number: 15181428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: 12/26/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 01/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2023
• 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