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	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6)2026, a sales representative reported via(b)(4) that an ar-9925t syndesmosis tight rope pro implant experienced a bent inserter during insertion, resulting in premature deployment of the button.The deployed tight rope was cut out and replaced with a new implant, which was inserted without issue.The event occurred during an ankle fracture procedure on (b)(6)2026.The surgery was delayed by approximately 2 minutes.No additional anesthesia was administered, and no patient harm was reported.Additional information was received on 08-sep-2026: the inserter was observed to be bent after exiting the far cortex.The button was deployed after the inserter bent as it exited the far cortex.No excessive resistance was encountered during insertion; however, slight resistance was noted while attempting to advance the button through the far cortex.Visual damage was observed on the l-shaped portion of the inserter following removal.No portion of the affected implant remained in the patient.The procedure was completed using a replacement implant of the same part number.The drill bit included in the kit was used to prepare the bone socket for insertion.The patient's bone quality was reported as good.
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: 50770803
• Report Number: 1220246-2026-04717
• Device Sequence Number: 13129447
• Product Code: HTN
• UDI-Device Identifier: 00888867569447
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/15/2026

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: 15611230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/23/2026
• 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