MAUDE Adverse Event Report: ARTHREX, INC. Ø7X 20MM PEEK IF SCRW NON-VENTED; NON-DEGRADABLE FIXATN FASTENER

Model Number Ø7X 20MM PEEK IF SCRW NON-VENTED

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/14/2024

Event Type  malfunction  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

On 3/21/2024, an fda medwatch notification was received via email.A facility nurse reported that an ar-4020p-07 fastthread peek interference screw was not an adequate fit.As the surgeon removed the screwdriver, it was noticed the peek screw was not at the end of the screwdriver.The surgical site as well as the surrounding areas were searched for the screw but could not be located.An x-ray was taken using fluoroscopy and the screw could still not be located.An mri was taken post-operative which revealed a plastic screw in the patient's patellar pouch.This occurred during a patellar ligament repair procedure on (b)(6) 2024.Additional information received on 3/25/2024: on (b)(6) 2024, the patient underwent revision surgery and had the retained foreign object removed.No known harm to the patient during or after these procedures were completed.No additional information has been provide.Additional information received on 3/26/2024: the revision surgery took place on (b)(6) 2024, and the fastthread peek interference screw was successfully removed from inside the patient.No other arthrex products were explanted and no new products were implanted.The procedure was performed to only remove the fastthread peek interference screw.

• Brand Name: Ø7X 20MM PEEK IF SCRW NON-VENTED
• Type of Device: NON-DEGRADABLE FIXATN FASTENER
• 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: 19116689
• MDR Text Key: 340303635
• Report Number: 1220246-2024-02050
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867295001
• UDI-Public: 00888867295001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180662
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: Ø7X 20MM PEEK IF SCRW NON-VENTED
• Device Catalogue Number: AR-4020P-07
• Device Lot Number: 15155255
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/17/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1