MAUDE Adverse Event Report: Arthrex, Inc. Syndesmosis TightRope PRO Implant, Ti; WASHER, BOLT, NUT

Model Number	Syndesmosis TightRope PRO Implant, Ti
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 21-aug-2026, a sales representative reported via email that an ar-9925t syndesmosis tightrope pro implant experienced a button detachment from the tightrope prior to implantation.The issue was identified before use during a procedure on (b)(6) 2026.No patient harm was reported.Additional information was received on 26-aug-2026: the issue was identified while passing the button through the tibia.The button was reportedly discovered to be detached when attempting to set it on the medial side after a portion of the device had already entered the patient.The detached button was accounted for; however, it could not be reattached to the inserter.A replacement device of the same part number and lot number was used to complete the procedure.No surgical delay was reported.The procedure being performed was an ankle fracture with syndesmosis repair.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: Syndesmosis TightRope PRO Implant, Ti
• Common Device Name: WASHER, BOLT, NUT
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50690175
• Report Number: 1220246-2026-04634
• Device Sequence Number: 20312075
• Product Code: HTN
• UDI-Device Identifier: 00888867569447
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K253727
• 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
• Report Date (Section B): 09/09/2026

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: Syndesmosis TightRope PRO Implant, Ti
• Device Catalogue Number: AR-9925T
• Device Lot Number: 15653557
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2026
• 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