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	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 02-sep-2026, it was reported by a sales representative via phone that an ar-9925t tightrope button, after drilling femoral tunnel and pressing button to seat tightrope, entire button came loose but was still attached to driver and pulled back through tunnel.Tried reseating to no effect.New device opened and case completed with no patient effect.
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: 50804481
• Report Number: 1220246-2026-04788
• Device Sequence Number: 12910814
• Product Code: HTN
• UDI-Device Identifier: 00888867569447
• UDI-Public: (01)00888867569447(11)260724(17)310630(10)15659029
• 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): 09/17/2026

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: 15659029
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2026
• 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