MAUDE Adverse Event Report: ARTHREX, INC. KNOTLESS MINI TR IMPLANT, 2.7MM, TI; WASHER, BOLT, NUT

Model Number	KNOTLESS MINI TR IMPLANT, 2.7MM, TI
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/21/2022, it was reported by a sales representative via email that an ar-8908ds knotless mini tightrope feedline broke.Surgeon was able to remove it backwards and open a new one to complete the case without further issues.This was discovered during a lis franc procedure on (b)(6) 2022.Additional information received on 11/22/2022: case was completed using another ar-8908ds knotless mini tightrope from the same lot number.
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 device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: KNOTLESS MINI TR IMPLANT, 2.7MM, 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: 19499204
• Report Number: 1220246-2024-05412
• Device Sequence Number: 6652805
• Product Code: HTN
• UDI-Device Identifier: 00888867351578
• UDI-Public: 00888867351578
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K213644
• 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): 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 Expiration Date: 09/30/2026
• Device Model Number: KNOTLESS MINI TR IMPLANT, 2.7MM, TI
• Device Catalogue Number: AR-8908DS
• Device Lot Number: 14263338
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2021
• 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