MAUDE Adverse Event Report: Arthrex, Inc. Ø7X 30MM PEEK IF SCRW NON-VENTED; NON-DEGRADABLE FIXATN FASTENER

Model Number	Ø7X 30MM PEEK IF SCRW NON-VENTED
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgery that the screws are not providing sufficient fixation.As a result, instead of using two screws as initially planned, they are sometimes required to use additional screws or a larger size to finish the surgery successfully.Per complaint reporter there was no harm for patient, operator or third party.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: Ø7X 30MM PEEK IF SCRW NON-VENTED
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50838389
• Report Number: 1220246-2026-04829
• Device Sequence Number: 21344972
• Product Code: MAI
• UDI-Device Identifier: 00888867295049
• UDI-Public: 00888867295049
• Combination Product (Y/N): N
• Initial Reporter Country: MD
• PMA/510(K) Number: K202535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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 30MM PEEK IF SCRW NON-VENTED
• Device Catalogue Number: AR-4030P-07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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