MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX®; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	AR-8991CP
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An anchor from the dx knotless fiber tak instability implant kit was broke off/retained during the procedure.

• Brand Name: ARTHREX®
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside blvd; naples FL 34108
• MDR Report Key: 25228934
• Report Number: 25228934
• Device Sequence Number: 13351473
• Product Code: MBI
• UDI-Device Identifier: 00888867424715
• UDI-Public: (01)00888867424715(17)301031(10)15541096
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/12/2026
• Report Date (Section F): 05/12/2026

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: AR-8991CP
• Device Catalogue Number: AR-8991CP
• Device Lot Number: 15541096
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/20/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/20/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 15 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Date Report Sent to FDA: 05/12/2026