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	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/10/2019
Type of Reportable Event	Serious Injury
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 30 degree hd arthroscope, ar-3350-4030, was being used during a procedure.During the surgery, the view through the arthroscope was very vague and the surgeon was unable to see the structure of the patient's tissue clearly.As no other arthroscope was available for the procedure, the surgeon had to terminate the surgery and reschedule for another day after speaking with the patient and their family.The arthroscope was sent to a third party for repair and will not be returned as it is no longer in the condition it was at the time of the incident detailed above.

• 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: 9631793
• Report Number: 1220246-2020-01613
• Device Sequence Number: 14245896
• Product Code: HRX
• UDI-Device Identifier: 00888867029637
• UDI-Public: 00888867029637
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K080560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/27/2020

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: 10286962
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 01/27/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other