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

Catalog Number 0606-563-000

Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)

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

Event Date 04/26/2019

Event Type  malfunction  

Event Description

Mixer blade of cement mixer was not attached and fell off, making it unusable.

• Brand Name: REVOLUTION
• Type of Device: MIXER, CEMENT, FOR CLINICAL USE
• Manufacturer (Section D): STRYKER INSTRUMENTS; 4100 east milham ave.; kalamazoo MI 49001
• MDR Report Key: 9197679
• MDR Text Key: 162515259
• Report Number: 9197679
• Device Sequence Number: 1
• Product Code: JDZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 0606-563-000
• Device Lot Number: 18282012
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/12/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/16/2019
• Type of Device Usage: N
• Patient Sequence Number: 1