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

Model Number	Syndesmosis TightRope PRO Implant, SS
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 28-aug-2026, a sales representative reported via email that an ar-9925ss syndesmosis tightrope pro implant experienced a button deployment issue during an ankle syndesmosis procedure on (b)(6) 2026.After the implant was passed through the bone and plate, the button reportedly did not flip off the inserter as intended.The device was removed.No harm to the patient was reported.Additional information was received on 31-aug-2026: the button failed to flip after being passed through the bone and plate.The surgeon attempted to deploy the implant according to the surgical technique and palpated the medial side of the ankle in an effort to facilitate button deployment; however, the button did not flip.The button was observed to remain attached to the inserter and did not appear to release from the inserter despite activation of the black deployment button.The entire implant was inserted through the fibula and tibia before the issue was identified.The implant was subsequently removed by pulling it straight out through the pre-drilled hole.Resistance was encountered during removal, and the tightrope construct began to tension; however, all implant components were successfully removed from the patient.Syndesmosis fixation was completed using a replacement ar-9925ss syndesmosis tightrope pro implant.No surgical delay occurred, and no additional anesthesia was administered.No instrument was used to prepare the bone socket.The surgeon described the patient's bone quality as normal.No instrument or implant breakage occurred.No adverse patient effects have been reported during or following the procedure related to this event.
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, SS
• 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: 50733338
• Report Number: 1220246-2026-04689
• Device Sequence Number: 10591925
• Product Code: HTN
• UDI-Device Identifier: 00888867569423
• UDI-Public: (01)00888867569423(11)260716(17)310630(10)15655149
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/11/2026

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, SS
• Device Catalogue Number: AR-9925SS
• Device Lot Number: 15655149
• 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: 08/28/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2026
• 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