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

Device Problem Defective Device (2588)

Patient Problem No Code Available (3191)

Event Date 03/10/2020

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 during a procedure, the motor on the apsii shaver, ar-8330f, was not working and the surgeon had to switch to an open procedure.Additional information requested.Additional information provided 6/1/2020: this occurred during an acl procedure and the shaver did not show any alarm or error messages.

Manufacturer Narrative

(motor hall sensor) the evaluation confirmed the reported event.The cause was attributed to a defective motor hall sensor.

• Brand Name: APS II SHVR HANDP,FT-SWCH CNTRL
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10159859
• MDR Text Key: 195365888
• Report Number: 1220246-2020-01896
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 00888867043220
• UDI-Public: 00888867043220
• Combination Product (y/n): N
• PMA/PMN Number: K932699
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 08/05/2021

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: APS II SHVR HANDP,FT-SWCH CNTRL
• Device Catalogue Number: AR-8330F
• Device Lot Number: 10161916
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/28/2020
• Initial Date FDA Received: 06/16/2020
• Supplement Dates Manufacturer Received: 05/28/2020
• Supplement Dates FDA Received: 08/05/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other