MAUDE Adverse Event Report: ARTHREX, INC. ARTHROSCOPE, 30 DEG, 2.4 X 72MM

Model Number ARTHROSCOPE, 30 DEG, 2.4 X 72MM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 02/23/2021

Event Type  malfunction  

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 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.

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: ARTHROSCOPE, 30 DEG, 2.4 X 72MM
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11475497
• MDR Text Key: 239506312
• Report Number: 1220246-2021-02720
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00888867029545
• UDI-Public: 00888867029545
• Combination Product (y/n): N
• PMA/PMN Number: K080560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: ARTHROSCOPE, 30 DEG, 2.4 X 72MM
• Device Catalogue Number: AR-3350-2430
• Device Lot Number: 11295901
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/23/2021
• Initial Date FDA Received: 03/12/2021
• Supplement Dates Manufacturer Received: 02/23/2021
• Supplement Dates FDA Received: 09/03/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other