MAUDE Adverse Event Report: ARTHREX, INC. HD ARTHROSCOPE, 30 DEG, 4 X 152.5MM

Model Number	HD ARTHROSCOPE, 30 DEG, 4 X 152.5MM
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that the following devices were present during a procedure,ar-3350-2430, ar-3350-4030, ar-3210-0001, ar-8330f, were a patient got an infection.It was found that the infection is not due to arthrex product(s), however, customer would like to change all their products that were used during this procedure.
Additional Manufacturer Narrative
Complaint not confirmed.The evaluation did not identify any issues relevant to the reported event.Also, as stated in the complaint's narrative the infection is not due to arthrex product(s).

• Brand Name: HD ARTHROSCOPE, 30 DEG, 4 X 152.5MM
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11475243
• Report Number: 1220246-2021-02709
• Device Sequence Number: 4041015
• Product Code: HRX
• UDI-Device Identifier: 00888867029637
• UDI-Public: 00888867029637
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K080560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2021

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: HD ARTHROSCOPE, 30 DEG, 4 X 152.5MM
• Device Catalogue Number: AR-3350-4030
• Device Lot Number: 10224114
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 09/03/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other