MAUDE Adverse Event Report: ARTHREX, INC. Ø8 X 30MM PEEK IF SCRW NON-VENTED; BIO SOFT TISSUE FIXATN FASTNR

Model Number	Ø8 X 30MM PEEK IF SCRW NON-VENTED
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during an acl repair surgery the screw was slightly tilted so that the surgeon couldn't get a good grip with the screwdriver.There was no harm for patient, operator or third party.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.
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 for the reported failure can be attributed to user error due to misaligned insertion and/or improper bone preparation.

• Brand Name: Ø8 X 30MM PEEK IF SCRW NON-VENTED
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: 20041406
• Report Number: 1220246-2024-07243
• Device Sequence Number: 20807470
• Product Code: MAI
• UDI-Device Identifier: 00888867295056
• UDI-Public: 00888867295056
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 06/23/2025

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: Ø8 X 30MM PEEK IF SCRW NON-VENTED
• Device Catalogue Number: AR-4030P-08
• Device Lot Number: 15009811
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2024
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/07/2022
• 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