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	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device could not be tensioned sufficiently because it locked up prematurely.It had to be removed from the patient.According to the surgeon no harm or adverse event for patient, operator or third party occurred.No further information was provided.Update avoe 06-apr-2021: the arthroscopy 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.Complaint confirmed.Visual evaluation identified suture breakage at both the round and oblong buttons of the returned ar-8926t.Suture has signs of being frayed.Also, superficial surface damage was identified across the oblong button component.The complaint device was not received for evaluation, based off the information provided, the most likely cause cause for the reported failure is due to the result of the application of excessive force during the process of tightening the suture and/or the mishandling of the device based on the damaged state of the returned device.

• 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: 19539180
• Report Number: 1220246-2024-05815
• Device Sequence Number: 6030987
• Product Code: HTN
• UDI-Device Identifier: 00888867049086
• UDI-Public: 00888867049086
• 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,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/14/2024

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 Expiration Date: 07/31/2025
• Device Model Number: KNOTLESS T-ROPE SYN-DESMOSIS REPR TI
• Device Catalogue Number: AR-8926T
• Device Lot Number: 23333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2020
• 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