MAUDE Adverse Event Report: ARTHREX ARTHREX; BURR

Model Number AR-8500FOE

Device Problem Bent (1059)

Patient Problem No Information (3190)

Event Date 09/08/2016

Event Type  Injury  

Event Description

During use end of shaver, blade became bent and distorted.

• Brand Name: ARTHREX
• Type of Device: BURR
• Manufacturer (Section D): ARTHREX; napels FL 34108
• MDR Report Key: 5945831
• MDR Text Key: 54666510
• Report Number: MW5064678
• Device Sequence Number: 1
• Product Code: HTT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: AR-8500FOE
• Device Lot Number: 10034577
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/08/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR