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	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a sindesmosis instability surgery after positioning the knotless tighrope and pulling the fiberwire sutures, the system broke / frayed the fiberwire.All broken parts were retrieved from the patient.According to the surgeon no harm for patient, operator or third party occurred.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
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint allegation cannot be confirmed without the device for evaluation.The device was not received for evaluation, and no photos of the failure were provided.Per the event description, the most likely cause for the reported failure is user error.According to dfu-0147-8.Precautions.0.Acl/pcl/btb/rt/abs tightrope only: excessive force on the shortening suture strands and/or tensioning the shortening suture strands not in-line with the bone socket may break the strands and impair ability to fully seat the implant.No additional force on the shortening suture strands is required when the graft/wedge construct reaches the desired position in the femoral socket and the graft stability is verified by pulling distally on the graft.2.Load the acl/pcl tightrope button over the unspliced, thinner portion of the acl/pcl tightrope suture to assist assembly.Once assembled slide the acl/pcl tightrope button down to the thicker, spliced portion of the acl/pcl tightrope suture to help prevent disassembly.

• 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: 19505252
• Report Number: 1220246-2024-05480
• Device Sequence Number: 7072303
• Product Code: HTN
• UDI-Device Identifier: 00888867049086
• UDI-Public: 00888867049086
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K043248
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/10/2024

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: 26976
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2022
• 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