MAUDE Adverse Event Report: ARTHREX, INC. APS II SHVR HANDP,FT-SWCH CNTRL; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	APS II SHVR HANDP,FT-SWCH CNTRL
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, whereas 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
(no problem found) the evaluation did not reveal any issues relevant to the reported event.
Additional Manufacturer Narrative
(no problem found) the evaluation did not reveal any issues relevant to the reported event.

• Brand Name: APS II SHVR HANDP,FT-SWCH CNTRL
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11485644
• Report Number: 1220246-2021-02752
• Device Sequence Number: 3913057
• Product Code: HWE
• UDI-Device Identifier: 00888867043220
• UDI-Public: 00888867043220
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K932699
• 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,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: APS II SHVR HANDP,FT-SWCH CNTRL
• Device Catalogue Number: AR-8330F
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 02/23/2021; 02/23/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 08/10/2021; 09/03/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other