MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX®; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	AR-7820
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Fibertape cerclage disposable tensioner x 2 opened, malfunctioning per surgeon, alternative tray used to complete procedure.

• Brand Name: ARTHREX®
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside blvd.; naples FL 34108
• MDR Report Key: 24578858
• Report Number: 24578858
• Device Sequence Number: 9434992
• Product Code: LXH
• UDI-Device Identifier: 00888867373976
• UDI-Public: (01)00888867373976(17)290
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/14/2026
• Report Date (Section F): 01/14/2026

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
• Device Model Number: AR-7820
• Device Catalogue Number: AR-7820
• Device Lot Number: 4214151436
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 03/12/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/12/2026
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/14/2026