MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS, INC. FORMULA AGGRESSIVE PLUS CUTTER (RED/BLUE); ARTHROSCOPE

Model Number 375-544-000

Device Problem Metal Shedding Debris (1804)

Patient Problem No Information (3190)

Event Date 02/20/2017

Event Type  malfunction  

Event Description

During case, metal pieces were observed coming off the shaver.

• Brand Name: FORMULA AGGRESSIVE PLUS CUTTER (RED/BLUE)
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 5300 region ct.; lakeland FL 33815
• MDR Report Key: 6371510
• MDR Text Key: 68767904
• Report Number: 6371510
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2017,02/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 375-544-000
• Device Catalogue Number: 375-544-000
• Device Lot Number: 5491151
• Other Device ID Number: 4MM
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/22/2017
• Event Location: Hospital
• Date Report to Manufacturer: 02/22/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/02/2017
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 91