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

Catalog Number 0606-563-000

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 07/03/2014

Event Type  malfunction  

• 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: 3983122
• Report Number: 3983122
• Device Sequence Number: 1
• Product Code: JDZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/15/2014

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: Invalid Data
• Device Catalogue Number: 0606-563-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/15/2014
• Event Location: Hospital
• Date Report to Manufacturer: 08/06/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/15/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR