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

Model Number	AR-1409LP
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Surgical attending informed circulating rn that the arthrex reamer drill bit tip broke off - pieces were collected and no harm to the patient.The broken item was an arthrex low profile reamer 9mm.Item # ar-1409lp, lot # 15125284, and expiration date of 07/31/2028.

• Brand Name: ARTHREX®
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside blvd.; naples FL 34108
• MDR Report Key: 18491051
• Report Number: 18491051
• Device Sequence Number: 6991914
• Product Code: LXH
• UDI-Device Identifier: 00888867016767
• UDI-Public: (01)00888867016767
• 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): 08/25/2023
• Report Date (Section F): 08/25/2023

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
• Operator of Device: Health Professional
• Device Model Number: AR-1409LP
• Device Catalogue Number: AR-1409LP
• Device Lot Number: 15125284
• 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: 01/11/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/11/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/25/2023