MAUDE Adverse Event Report: ARTHREX, INC. KNOTLESS T-ROPE SYN-DESMOSIS REPR TI; WASHER, BOLT, NUT

Model Number	KNOTLESS T-ROPE SYN-DESMOSIS REPR TI
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during a syndesmosis rupture surgery when tightening the suture construct, the suture broke at the height of the button.All broken parts were retrieved from the patient.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Visual evaluation of the ar-8926t shows the broken suture detached from the button.Functional testing could not be performed due to the damage to the device.Complaint allegation is confirmed.The most likely cause for the reported event can be attributed to user error of the device due to excessive force used during suture passing/tightening /tensioning.

• Brand Name: KNOTLESS T-ROPE SYN-DESMOSIS 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: 21409928
• Report Number: 1220246-2025-00535
• Device Sequence Number: 13090757
• Product Code: HTN
• UDI-Device Identifier: 00888867049086
• UDI-Public: (01)00888867049086(11)241001(17)290930(10)31883
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K043248
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2025

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: KNOTLESS T-ROPE SYN-DESMOSIS REPR TI
• Device Catalogue Number: AR-8926T
• Device Lot Number: 31883
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2025
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2024
• 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