MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS STRYKER CEMENT MIX SYSTEM; MIXER, CEMENT, FOR CLINICAL USE

Device Problems Failure to Fire (2610); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2017

Event Type  malfunction  

Event Description

During a surgical procedure cement was mixed with the stryker cement mix system.While applying cement the system malfunctioned and was not allowing the cement gun to completely fire.The doctor applied the cement with added effort.There was no injury to the patient.

• Brand Name: STRYKER CEMENT MIX SYSTEM
• Type of Device: MIXER, CEMENT, FOR CLINICAL USE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS
• MDR Report Key: 6427209
• MDR Text Key: 70689472
• Report Number: MW5068581
• Device Sequence Number: 1
• Product Code: JDZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 86 YR
• Patient Weight: 61