MAUDE Adverse Event Report: ARTHREX, INC. PEEK, MENISCAL ROOT REPAIR KIT; NON-DEGRADABLE FIXATN FASTENER

Model Number	PEEK, MENISCAL ROOT REPAIR KIT
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	01/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 26-jan-2026, it was reported by a sales representative via (b)(4) that an ar-4550p meniscal root repair with peek swivelock implant system had been implanted recently and the patient has an infection.Additional information has been requested.Additional information provided on 03-feb-2026: it was further reported that the infection was localized and was identified as an mssa infection and the patient is now stable.The arthrex products were initially implanted in an acl reconstruction with btb autograft, internal brace procedure for an acl tear.The devices have since been explanted.No intraoperative complications were reported.Additional information has been requested.

• Brand Name: PEEK, MENISCAL ROOT REPAIR KIT
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; 8009337001-73216
• MDR Report Key: 24324345
• Report Number: 1220246-2026-00553
• Device Sequence Number: 9475975
• Product Code: MBI
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K173845
• 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,Followup
• Report Date (Section B): 05/29/2026

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: PEEK, MENISCAL ROOT REPAIR KIT
• Device Catalogue Number: AR-4550P
• Device Lot Number: 15376447
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2025
• 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