MAUDE Adverse Event Report: STRYKER CORPORATION REVOLUTION; MIXER, CEMENT, FOR CLINICAL USE

Model Number	0606600000
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The cement mixer completely malfunctioned.All the liquid came out the bottom and top once i started mixing.It appeared to be defective.

• Brand Name: REVOLUTION
• Common Device Name: MIXER, CEMENT, FOR CLINICAL USE
• Manufacturer (Section D): STRYKER CORPORATION; 1941 stryker way; portage MI 49002
• MDR Report Key: 21558726
• Report Number: 21558726
• Device Sequence Number: 11869827
• Product Code: JDZ
• UDI-Device Identifier: 04546540437037
• UDI-Public: (01)04546540437037
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/20/2025
• Report Date (Section F): 02/20/2025

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
• Operator of Device: Other
• Device Model Number: 0606600000
• Device Catalogue Number: 0606600000
• Device Lot Number: 24316012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/10/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/20/2025