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	11/25/2025
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 a knee surgery the screw broke.The broken pieces were retrieved out of the patient.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 dw (b)(6) 2025: further information was provided that the fragment remained inside the patient and was not retrieved.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.-complaint allegation is confirmed.-visual inspection of the fastthread¿ biocomposite¿ interference screw 8 x 20 mm, identified that the screw was broken off; only one half of the screw was returned for investigation.-functional testing was not performed due to the damage to the device.The method of bone preparation and the quality of the bone encountered were not specified.Per dfu-0111-eo - g.Precautions - 4.Bio-tenodesis screw only: use the appropriate size arthrex drill to create a pilot hole in the bone.6.Bio-absorbable interference screw only: it is important to completely seat the screwdriver to prevent potential stripping of the hex and/or screw fracture during insertion or removal.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation, misalignment insertion, and/or prying/leveraging of the device during insertion.

• 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: 23828389
• Report Number: 1220246-2025-05660
• Device Sequence Number: 21154360
• Product Code: MAI
• UDI-Device Identifier: 00888867276963
• UDI-Public: (01)00888867276963(11)240702(17)280630(10)15281063
• 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): 02/11/2026

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: Ø8X 20MM BC IF SCRW, VENTED
• Device Catalogue Number: AR-4020C-08
• Device Lot Number: 15281063
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2024
• 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