MAUDE Adverse Event Report: ARTHREX, INC. 2-0 FW BLUE W/ TPR 1/2CIR NEEDLE; POLYETHYLENE SYNTHETIC SUTURE

Model Number	2-0 FW BLUE W/ TPR 1/2CIR NEEDLE
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/13/2021
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.Complaint could not be confirmed.Seventeen (17) unopened packages of ar-7242 were received for investigation.The complaint device was not returned for evaluation (image 1).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 misuse of the device due to damage to the device.
Event or Problem Description
On (b)(6) 2021, it was reported by a sales representative via e-mail that while the surgeon was using an ar-7242 fiberwire, the needle was rounded or dull and it is difficult for the surgeon to use as it doesn¿t cut through tissue very well.This was discovered during use in a chevron osteotomy on (b)(6) 2021.The case was completed with a new ar-7242.

• Brand Name: 2-0 FW BLUE W/ TPR 1/2CIR NEEDLE
• Common Device Name: POLYETHYLENE SYNTHETIC SUTURE
• 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: 19200325
• Report Number: 1220246-2024-02505
• Device Sequence Number: 7927320
• Product Code: GAT
• UDI-Device Identifier: 00888867041790
• UDI-Public: 00888867041790
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K122374
• 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: 02/28/2026
• Device Model Number: 2-0 FW BLUE W/ TPR 1/2CIR NEEDLE
• Device Catalogue Number: AR-7242
• Device Lot Number: 24376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown