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
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Foreign Body In Patient (2687)
Date of Event	02/14/2024
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional Manufacturer Narrative
Mw5152261.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause can be attributed to misuse due to misaligned insertion, or prying/leveraging the screw during insertion.

• Brand Name: Ø7X 20MM PEEK IF SCRW NON-VENTED
• Common Device Name: 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
• Report Number: 1220246-2024-02050
• Device Sequence Number: 15347407
• Product Code: MAI
• UDI-Device Identifier: 00888867295001
• UDI-Public: 00888867295001
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K180662
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/09/2025

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 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided; 05/17/2025
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 07/18/2024; 08/14/2024; 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2023
• 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