MAUDE Adverse Event Report: ARTHREX, INC. Ø7X 30MM BC IF SCRW, VENTED; BIO SOFT TISSUE FIXATN FASTNR

Model Number	Ø7X 30MM BC IF SCRW, VENTED
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.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 a knee arthroscopy the screw tip turned off at the top of the screw.The screw was left in the patient.There was no harm for patient, operator or third party.The surgery was finished successfully with the broken screw.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 descriptions, and any additional information from the field, arthrex concluded that the most likely cause of the reported failure is user error including improper bone preparation, misaligned insertion, and/or prying or levering the device during insertion, which resulted in the device breaking.The complaint allegation was not confirmed.The device was not received for evaluation, and no evidence of the failure was received.

• Brand Name: Ø7X 30MM BC IF SCRW, 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: 18804308
• Report Number: 1220246-2024-01194
• Device Sequence Number: 17925028
• Product Code: MAI
• UDI-Device Identifier: 00888867277649
• UDI-Public: 00888867277649
• 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): 06/05/2025

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 30MM BC IF SCRW, VENTED
• Device Catalogue Number: AR-4030C-07
• Device Lot Number: 15110866
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2024
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 02/28/2024
• Supplement Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2023
• 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