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

Model Number	AR-1410LP
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
While using arthrex reamer low profile 10mm ref ar-1410lp lot 14922102, inside patient's left knee, the reamer end broke into three pieces, all three pieces removed from knee.Continued and completed with surgery without any other adverse events.Reamer pieces given to nurse manager.

• Brand Name: ARTHREX®
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside blvd; naples FL 34108
• MDR Report Key: 17583745
• Report Number: 17583745
• Device Sequence Number: 11662828
• Product Code: LXH
• UDI-Device Identifier: 00888867016811
• UDI-Public: (01)00888867016811
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/17/2023
• Report Date (Section F): 05/17/2023

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-1410LP
• Device Catalogue Number: AR-1410LP
• Device Lot Number: 14922102
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/21/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/21/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/17/2023