MAUDE Adverse Event Report: Arthrex, Inc. Ø9X 20MM BC IF SCRW, VENTED; BIO SOFT TISSUE FIXATN FASTNR

Model Number	Ø9X 20MM BC IF SCRW, VENTED
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Granuloma (1876); Swelling/ Edema (4577)
Date of Event	06/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On 14-aug-2026, a sales representative reported via email that a patient who underwent an acl reconstruction on (b)(6) 2025 developed a caseating granuloma at the tibial screw site.The procedure involved a btb acl reconstruction utilizing an ar-4020c-07 fastthread biocomposite interference screw (7 x 20 mm) in the femur and an ar-4020c-09 fastthread biocomposite interference screw (9 x 20 mm) in the tibia.The reported reaction was localized to the tibial site associated with the ar-4020c-09 screw.No issues were reported with the ar-4020c-07 screw implanted in the femur.Additional information was received on 19-aug-2026: follow-up information was received from the surgeon.The surgeon reported that the first signs and symptoms were observed in (b)(6) 2026 and consisted of painful swelling.The surgeon further reported that the diagnosis of a caseating granuloma was based on mri findings and operative findings.Cyst formation was reportedly identified, and the surgeon suspected the screw contributed to the granuloma because the reaction was localized to the screw location.The surgeon reported that pathology and culture results showed no evidence of infection.Infection was reportedly ruled out based on the absence of clinical signs of infection and negative culture results.The granuloma was surgically removed.The arthrex implants were not removed, and screw remnants remain in the tibia and femur.No revision surgery is planned to remove the tibial screw.No device was removed or retained for evaluation.At the time of follow-up, the surgeon reported that the patient was approximately one-week post-treatment, and no ongoing symptoms or residual effects had been reported to date.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: Ø9X 20MM BC IF SCRW, VENTED
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50497111
• Report Number: 1220246-2026-04521
• Device Sequence Number: 16100130
• Product Code: MAI
• UDI-Device Identifier: 00888867276970
• UDI-Public: (01)00888867276970(11)250623(17)290531(10)15454391
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K202535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: Ø9X 20MM BC IF SCRW, VENTED
• Device Catalogue Number: AR-4020C-09
• Device Lot Number: 15454391
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2026
• Initial Report FDA Received Date: 08/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown