MAUDE Adverse Event Report: STRYKER STRYKER; FORMULA AGGRESSIVE PLUS CUTTER

Model Number 375-544-000

Device Problem Metal Shedding Debris (1804)

Patient Problem No Information (3190)

Event Date 01/07/2016

Event Type  Injury  

Event Description

The operating room was using a reprocessed stryker formula aggressive plus cutter when the doctor noticed metal shavings coming off the device.The doctor immediately removed the device and thoroughly irrigated the site.

• Brand Name: STRYKER
• Type of Device: FORMULA AGGRESSIVE PLUS CUTTER
• Manufacturer (Section D): STRYKER; lakeland FL
• MDR Report Key: 5409563
• MDR Text Key: 37526501
• Report Number: MW5059977
• Device Sequence Number: 1
• Product Code: HRX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/08/2016

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: 11/30/2018
• Device Model Number: 375-544-000
• Device Lot Number: 4018588
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2016
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR
• Patient Weight: 80