MAUDE Adverse Event Report: ARTHREX, INC. Ø10X 30MM BC IF SCRW, VENTED; BIO SOFT TISSUE FIXATN FASTNR

Model Number	Ø10X 30MM BC IF SCRW, VENTED
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	01/06/2026
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
On 12-jan-2026, an arthrex subsidiary employee reported that an ar-4030c-10 fastthread biocomposite interference screw (10 × 30 mm) fractured in half during tibial fixation in an acl reconstruction performed on (b)(6) 2026.The graft was prepared with supersutures and measured 8.5 mm in diameter.The tibial tunnel was created using an 8 mm drill bit and subsequently dilated to 8.5 mm.During insertion of the 10 × 30 mm interference screw, the surgeon noted increased resistance, and the screw fractured.An attempt to retrieve the tip of the screw fragment was unsuccessful.The surgeon assessed knee stability intraoperatively and completed fixation using a non-arthrex 4.5 mm cortical screw post.Additional information was requested on 14-jan-2026.

• Brand Name: Ø10X 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: 24164277
• Report Number: 1220246-2026-00300
• Device Sequence Number: 13159206
• Product Code: MAI
• UDI-Device Identifier: 00888867277670
• UDI-Public: (01)00888867277670(11)250829(17)290731(10)15490682
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 05/13/2026

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: Ø10X 30MM BC IF SCRW, VENTED
• Device Catalogue Number: AR-4030C-10
• Device Lot Number: 15490682
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2025
• 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