MAUDE Adverse Event Report: ARTHREX, INC. Ø8X 20MM BC IF SCRW, VENTED; BIO SOFT TISSUE FIXATN FASTNR

Model Number	Ø8X 20MM BC IF SCRW, VENTED
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a knee surgery the device broke.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update kpilz 17-jun-2025: further information was received that there will be no revision surgery.Update kpilz 16-jun-2025: further information was received that some fragments remained inside the patient.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-4020c-08, batch 15314341 was received for evaluation.A visual inspection confirmed that the bio screw was fractured.Only a fragment of the screw was returned for evaluation.Notably, damage to the threads was observed on the returned piece.Functional testing was not performed due to the device being damaged.The most likely cause for the reported failure is user error for applying excessive force during insertion or through leveraging/prying the device.

• Brand Name: Ø8X 20MM 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: 22285000
• Report Number: 1220246-2025-02526
• Device Sequence Number: 18213318
• Product Code: MAI
• UDI-Device Identifier: 00888867276963
• UDI-Public: (01)00888867276963(11)240909(17)280831(10)15314341
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 09/03/2025

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: Ø8X 20MM BC IF SCRW, VENTED
• Device Catalogue Number: AR-4020C-08
• Device Lot Number: 15314341
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2024
• 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