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	Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/17/2022
Type of Reportable Event	Malfunction
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 contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The most likely cause for the reported failure can be attributed to a manufacturing issue; however, due to the device not being returned, we are unable to confirm the reported event.As no further investigation was able to be performed no change in harm was identified.This complaint will be included in trending per (b)(4).
Event or Problem Description
On 03/17/2022, it was reported by a sales representative via email that an ar-8958tds dual tightrope syndesmosis implant system, while tensioning down the second tightrope from the kit one of the sutures of the loops as it was going through the button was bunching up and wouldn't tighten.Upon further and closer examination the surgeon determined that one of the four holes located on the plate side button did not have any suture going through it.The tightrope was cut out and a new tightrope was opened to replace.Case was complete without further issues.This was discovered during a syndesmosis repair procedure on (b)(6) 2022.

• 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: 19203239
• Report Number: 1220246-2024-02560
• Device Sequence Number: 7927417
• Product Code: HTN
• UDI-Device Identifier: 00888867249790
• UDI-Public: 00888867249790
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/29/2024

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: 09/30/2025
• Device Model Number: IMPL SYS, DUAL TR SYNDESMOSIS 2H PLATE
• Device Catalogue Number: AR-8958TDS
• Device Lot Number: 23678
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown