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 Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/08/2020

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

Before starting the procedure, the shaver, ar-8330f, was tested and the shaver would not run.So, the surgeon change the procedure to an open procedure instead.

Manufacturer Narrative

Complaint confirmed.(motor hall sensor) the evaluation determined that the reported event was caused by a motor hall sensor malfunction.

• 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: 10213459
• MDR Text Key: 199684209
• Report Number: 1220246-2020-01928
• 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

• Date FDA Received: 06/30/2020
• 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: 10132667
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/11/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other