MAUDE Adverse Event Report: ARTHREX, INC. IMPL SYS, DUAL TR SYNDESMOSIS 2H PLATE; WASHER, BOLT, NUT

Model Number	IMPL SYS, DUAL TR SYNDESMOSIS 2H PLATE
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/13/2022, it was reported by a sales representative via email that the tightrope from an ar-8958tds dual tightrope syndesmosis implant system, would not tension on one side.This was discovered while assembling the tightrope during a procedure on (b)(6) 2022.Case was completed by using an individual ar-8926t knotless tightrope.
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 most likely cause for the reported failure can be attributed to user error of the device due to excessive force used during suture passing/tightening /tensioning.However, due to the device being returned unpackaged, we are unable to confirm the reported event.

• Brand Name: IMPL SYS, DUAL TR SYNDESMOSIS 2H PLATE
• 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: 19033503
• Report Number: 1220246-2024-01797
• Device Sequence Number: 7020002
• Product Code: HTN
• UDI-Device Identifier: 00888867249790
• UDI-Public: 00888867249790
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K043248
• 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): 04/03/2024

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: 09/30/2024
• Device Model Number: IMPL SYS, DUAL TR SYNDESMOSIS 2H PLATE
• Device Catalogue Number: AR-8958TDS
• Device Lot Number: 21987
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2019
• 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